VIEW ATReview User Documentation
VIEW ATReview
User Documentation
1. Introduction
VIEW ATReview is a cloud-based system that supports the analysis, review, and approval of relevant GxP system audit trail records. This is the VIEW ATReview application User Documentation.
This section defines the terms and acronyms used in this document.
Term or Acronym
Definition
VIEW
Validated Integrated Enterprise Workflows
ATReview
Audit Trail Review
GxP
“Good x Practice” quality guidelines and regulations. The “x” stands for various fields e.g. GMP Good Manufacturing Practice or GLP Good Laboratory Practice
CompliantCloud
Odyssey VC owned Qualified Hosting Infrastructure
FDA
Federal Drug Administration
CFR
Code of Federal Regulations
EMA
European Medicines Agency
SSO
Single Sign-On
ID
Identifier
CPP
Critical Process Parameter
CC
Change Control
SOP
Standard Operating Procedure
IP
Internet Protocol
RPC
Relevant Parameter Change
2. Purpose
The purpose of this User Documentation is to guide users on how to access, use and/or troubleshoot the VIEW ATReview product. Through the assistance of this User Documentation, the user will be able to navigate the VIEW ATReview easily and ensure they are getting the full value of the product.
3. Scope
The scope of this user documentation covers the entire user functionality of VIEW ATReview application. How to manage relevant audit trail records, register systems and non-attributable users, retrace activity, and export data to reports.
4. Welcome to VIEW ATReview
VIEW ATReview is a cloud-based system that supports the analysis, review, and approval of GxP system audit trail records. VIEW ATReview helps identify if system audit trail records are completed in accordance with life science regulatory expectations and guidelines. An audit trail record is considered “complete” if it has the Who (attributable), the When, the Where, the What and the Why. This is achieved by using ‘smart’ exception rules defined in the VIEW ATReview Inclusion Registry, which passes original relevant parameter change record data from GxP production systems to VIEW ATReview, where it is assessed for completeness. All relevant parameter change records, for example a system CPP (Critical Process Parameter) change, which require attention by a responsible owner, are logged within VIEW ATReview and can be analysed, reviewed, and approved in real-time.
Compliant Audit Trail Review Solution for GxP Systems
Figure 1: ATReview Solution
GxP system audit trail records are delivered to VIEW ATReview through a secure cloud connection.
GxP system audit trail records are filtered for Relevant Parameter Change records as per pre-defined rules in VIEW ATReview Inclusion Registry
Automatically identified incomplete records are marked for analysis, review, and approval.
VIEW ATReview is delivered as a validated system and hosted on the Odyssey VC CompliantCloud platform.
CompliantCloud is a fully qualified IaaS platform designed from the ground up to meet global life sciences regulations, such as FDA 21 CFR Part 11 and EMA Annex 11. The qualified status of CompliantCloud is fully demonstrable, evidence-backed, and audit-ready always.
Figure 2:VIEW Product Family
5. Get Started with VIEW ATReview
Log in to VIEW ATReview through the CompliantCloud portal using your Single Sign-On (SSO) credentials (Username and Password). Click Sign In.
Figure 3: CompliantCloud Sign In Portal
After Sign In, you will be directed to the VIEW product family homepage.
Figure 4: VIEW Product Family Homepage
Click on Profile Details on the top right-hand side to see
• Login profile details
• The application operating time zone
• ATReview application version number
• Logout feature
If you click on the Logout feature, you will be returned to the CompliantCloud sign in portal.
Figure 5: User Profile Details
In the VIEW product family homepage, click on the ATReview application where you will be directed to the default landing page Relevant Parameter Changes.
Figure 6: Default Landing Page Relevant Parameter Changes
5.1. Main Navigation
When you sign in to VIEW ATReview you will see the core areas of the ATReview application in the main navigation on the left-hand side. You can expand or collapse all the items of the main navigation simultaneously by clicking on the arrow icon to the top right of the vertical main navigation.
Figure 7: Main Navigation – Collapse/Expand
VIEW ATReview has five core areas that work together to enable users to analyse, review and approve relevant GxP system audit trail records.
Figure 8: Main Navigation – Core Areas
5.2. View Relevant Parameter Change Records
Select the Parameter Changes menu item to see a list of relevant audit trail parameter change records. The Parameter Changes summary page provides a list of all individually identified relevant parameter change records that have come from the registered systems.
Figure 9: Relevant Parameter Changes Summary Page
Each individual relevant audit trail parameter change record has an associated ID, Status, Attributable User, Date & Time Stamp, System, Change and Reason.
COLUMN HEADING
DESCRIPTION
ID
The VIEW ATReview application assigns an ID to every relevant audit trail parameter change record that is captured. This ensures that every relevant audit trail parameter change record within VIEW ATReview can be uniquely identified.
Status
A Status is assigned to every relevant audit trail parameter change record captured in VIEW ATReview. This assignment reflects the analysis, review, or approval status of a relevant audit trail parameter change record.
Attributable User
(Who)
Attributable User forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “Who”.
Date & Time Stamp
(When)
Date and Time forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “When”.
System
(Where)
System forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “Where”.
Change
(What)
Change forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “What”.
Reason
(Why)
Reason forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “Why”.
Table 1: Relevant Parameter Changes - Column Headings
6. Manage Relevant Parameter Change Records
VIEW ATReview helps identify if relevant audit trail parameter change records are completed in accordance with life science regulatory expectations and guidelines. VIEW ATReview helps identify if an audit trail parameter change record has the Who (attributable), the When, the Where, the What and the Why.
The very first time a relevant audit trail parameter change record is captured by VIEW ATReview there is an automatic check for “completeness”. The VIEW ATReview automatically checks if the relevant audit trail parameter change record has sufficient audit data i.e., data pertaining to the Who (attributable), the When, the Where, the What and the Why of the relevant activity on the GxP system.
COMPLETENESS DATA
DESCRIPTION
Who?
(Attributable User)
Who performed the activity associated with a relevant audit trail parameter change record, e.g., who performed a CPP (Critical Process Parameter) change?
When?
(Date & Time Stamp)
When did the activity associated with a relevant audit trail parameter change record take place, e.g., when was the CPP (Critical Process Parameter) changed?
Where?
(System)
Where (on which system) did the activity associated with a relevant audit trail parameter change record take place, e.g., on which system was the CPP (Critical Process Parameter) changed?
What?
(Change)
What did the activity associated with a relevant audit trail parameter change record change, e.g., what CPP (Critical Process Parameter) changed?
Why?
(Reason)
Why did the activity associated with a relevant audit trail parameter change record change take place, e.g., why did a CPP (Critical Process Parameter) change?
Table 2: Relevant Parameter Changes – Completeness Data
6.1. Relevant Parameter Status
VIEW ATReview will automatically check a newly captured relevant audit trail parameter change record for “completeness” and will assign an initial Status. The status of a captured relevant parameter change record will then evolve and change as it is analysed, reviewed, and approved by responsible owners.
Incomplete: The relevant audit trail parameter change record has missing and/or non-attributable data. The relevant audit trail parameter change record is considered incomplete if it is missing data associated with one or more of the Who, the When, the Where, the What, the Why. Also, a responsible owner can assign an Incomplete status if they consider the data to be inaccurate.
For Review: The relevant audit trail parameter change record has completed and attributable data and is waiting a review from a responsible owner.
Reviewed: The relevant audit trail parameter change record has complete, attributable data and it has been reviewed by a responsible owner. The relevant parameter change record is awaiting its final approval from a responsible owner.
Complete: The relevant audit trail parameter change record has complete, attributable data and has been reviewed and approved by all responsible owners.
6.2. Find Relevant Parameter Changes
All relevant audit trail parameter change records captured by VIEW ATReview will appear as line items in the Relevant Parameter Changes page(s). There can potentially be a significant number of relevant parameter changes captured, especially over time. ATReview has features to make it easy to find relevant audit trail parameter change records.
6.2.1. Pagination
ATReview utilises a pagination feature to order large lists of relevant parameter changes. You can choose the number of rows to view per page. Click on the drop-down arrow in the field beside Show rows per page to select the number of rows to be viewed pe
Figure 10: Pagination
6.2.2. Search
A built-in Search feature can be used to find relevant parameter changes of interest quickly & easily. You can do a free-text search for IDs, Attributable Users, Systems, Changes and Reasons. The Search feature in ATReview is not case sensitive. When you perform a search, the top results appear immediately. Click in the field with the search icon and search using keyword(s).
Figure 11: Search for Relevant Parameter Changes
6.2.3. Filter
You can use filters to help refine and simplify the sourcing of relevant parameter changes.
Click on Filters to expand and see all filter options.
Figure 12: Expand filters
You can filter by ID, Attributable User, Select date range, System and Status.
Click on the drop-down arrow on ID, Attributable User, System or Status to see initial top 5 suggested filter results for each section. Click into the filter field and type applicable text for more relevant filters.
For Select date range, click on the calendar symbol to choose a filter date range.
Click on Hide Filters to collapse the filter view.
Figure 13: Filter for Relevant Parameter Changes
6.2.4. Sort
You can sort Relevant Parameter Changes by Status, Attributable User, Date & Time Stamp and System. Click the upward and downward arrows located beside the column headings to sort by Status, Attributable User, Date & Time Stamp and System.
Figure 14: Sort Relevant Parameter Changes
6.3 How to Update Relevant Parameter Change Records and Change Status
When VIEW ATReview has automatically identified any missing and/or non-attributable data, it assigns an Incomplete status against the relevant audit trail parameter change record and highlights the data field(s) of concern in red.
Figure 15: Relevant Parameter Change Record with Missing Data
Click on a line item to see the details of that relevant audit trail parameter change record.
Figure 16: Relevant Parameter Change Record Details Page - Status Incomplete
As a responsible owner with the appropriate permissions, you can analyse the relevant audit trail parameter change record, and update the record data where required to ensure the relevant audit trail parameter change record is completed in accordance with life science regulatory expectations.
The data fields that can be updated are Attributable User, Change (old value and new value), Reason and SOP ID / CC ID. Data fields that cannot be updated are Status, Date & Time Stamp, System and ID.
FIELDS AVAILABLE FOR UPDATE
DESCRIPTION
Attributable User
Attributable User forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “Who”.
The identity of a person/system who performed an activity associated with a relevant audit trail parameter change record, e.g., a CPP (Critical Process Parameter) change, must be recorded to ensure data integrity.
Change
Change forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “What”. What did the activity associated with a relevant audit trail parameter change record change, e.g., what CPP (Critical Process Parameter) changed?
All audit trail records should reflect the reality of what happened and should be error-free.
Reason
Reason forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “Why”. Why did the activity associated with a relevant audit trail parameter change record change take place, e.g., why did a CPP (Critical Process Parameter) change?
The reason why some action was performed needs to be clearly understood, even years after it’s occurred. It is important to use consistent and straightforward language.
SOP ID / CC ID
Optional field to allow a relevant parameter change to be linked to an existing SOP (Standard Operating Procedure) ID or CC (Change Control) ID. This option allows for additional information to be provided for the What & the Why.
Table 3:Relevant Parameter Change Details Available for Update
FIELDS UNAVAILABLE FOR UPDATE
DESCRIPTION
Date & Time Stamp
Date and Time forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “When”. When did the activity associated with a relevant audit trail parameter change record take place, e.g., when was the CPP (Critical Process Parameter) changed? The ATReview application enforces that a contemporaneous Date & Time Stamp is recorded.
System
System forms part of the relevant data required to create a complete relevant audit trail parameter change record; it reflects the “Where”. Where (on which system) did the activity associated with a relevant audit trail parameter change record take place, e.g., on which system was the CPP (Critical Process Parameter) changed? The ATReview application ensures that only audit trail records from registered GxP Systems are captured.
ID
The VIEW ATReview application assigns an ID to every relevant audit trail parameter change record that is captured. This ensures that every relevant audit trail parameter change record within VIEW ATReview can be uniquely identified. This cannot be updated.
Table 4: Relevant Parameter Change Record Details Unavailable for Update
As a responsible owner with the appropriate permissions to update relevant audit trail parameter change records, you can update the available data fields as required to complete a relevant audit trail record. Once you are satisfied with the data, you can save it. Click Save.
Figure 17: Relevant Parameter Change Record Details Page - Update & Save
Once saved, the relevant audit trail parameter change record can be sent for review to another responsible owner. To send the relevant audit trail parameter change record to another responsible owner for review, you simply click Change Status.
Figure 18: Relevant Parameter Change Record Details Page - Change Status - Incomplete to For Review
A pop-up window is presented to allow you to complete the Change Status action, Click Yes if you want to complete the action or click Cancel if you want to cancel the action.
Figure 19: Change Status to For Review
If you choose to complete the Change Status action, then the Status will be changed from Incomplete to For Review and automatically saved. This is the only Change Status step allowed when a Relevant Parameter Change record is in Incomplete status.
Figure 20: Change Status Details Page - New Status For Review Saved
A responsible owner with the appropriate permissions to review relevant audit trail parameter change records will receive an automatic email notification, letting them know that a Status Change has occurred on a relevant audit trail parameter change record, and it is ready to be reviewed.
In the case where you choose to complete the Change Status action, i.e., you click Yes, but VIEW ATReview identifies some incomplete or non-attributable data within the relevant audit trail parameter change record, ATReview will block the Change Status action and highlight to you the reason why the Change Status action could not be performed.
Once you fulfil the criteria to satisfy a Change Status i.e., complete and/or attribute the user data of a relevant audit trail parameter change record, then you can proceed as wanted.
Figure 21: Change Status Blocked due to Incomplete Data
6.4 Email notification
Each time a Change Status is actioned in ATReview an automatic email notification will be sent to a responsible owner(s).
The Change Status action, for example, from Incomplete to For Review will trigger an automatic email notification to the responsible Business Owner.
Figure 22: Email Notification
6.5 How to Review Relevant Parameter Change Records and Change Status
As a responsible owner with the appropriate permissions to review relevant audit trial parameter change records, you will have been notified that there are relevant audit trail parameter change records ready for review. When you log in to VIEW ATReview you will see all relevant audit trail parameter change records. Search and/or Filter for the audit trail parameter change record in For Review Status.
Figure 23:Relevant Parameter Change Record in For Review Status
Click on a line item to see the details of that audit trail parameter change record.
Figure 24: Relevant Parameter Change Record Details Page - Status For Review
Review the relevant audit trail parameter change record in For Review status and select Change Status to action the relevant next step.
Figure 25: Select Status Change Action(1)
There are two Change Status options available when the relevant parameter change record is in For Review status.
Or
Selecting Reviewed will result in a pop-up window being presented to allow you to complete the Change Status action.
Figure 26: Complete Change Status Action to Reviewed
Before you finalise the Reviewed Change Status action you must confirm that you have reviewed the audit trail parameter change record by checking the tick box and entering your password. Click Confirm if you want to complete the action, this allows for an official e-Signature to be recorded against the Confirm action. Click Cancel if you want to cancel the action.
Confirming will Change Status from For Review to Reviewed.
Figure 27: Relevant Parameter Change Record Details Page – Status Reviewed (1)
A responsible owner with the appropriate permissions to review and complete relevant audit trail parameter change records will receive an automatic email notification, letting them know that a Status Change has occurred on a relevant audit trail parameter change record, and it is ready to be reviewed and approved.
Selecting the Change Status option Incomplete will result in a pop-up window being presented to allow you to complete the Change Status action.
Figure 28: Complete change Status Action to Incomplete (1)
Before you complete the Incomplete Change Status action you must provide a justification as to why you are reverting the Status from For Review to Incomplete.
Click Confirm if you want to complete the action for Change Status to Incomplete and the justification will be recorded in the Relevant Parameter Change record details. Click Cancel if you want to cancel the action.
Confirming will Change Status from For Review to Incomplete.
Figure 29: Relevant Parameter Change Record Details Page - Status Incomplete with Justification
A responsible owner with the appropriate permissions to update relevant audit trail parameter change records will receive an automatic email notification, letting them know that a Status Change has occurred on a relevant audit trail parameter change record, and it is ready to be updated.
A responsible owner with the appropriate permissions to update relevant parameter change record data, will see a Justification for Change of Status note in the Relevant Parameter Change record details.
Figure 30: Justification Note (1)
Figure 31: Updated Reason to Answer Justification Note
A responsible owner with the appropriate permissions to update relevant parameter change record data should respond appropriately, Save the updates and Change Status.
Once all concerns are answered the Relevant Parameter Change Record can move forward for final approval and completion.
6.6 How to Complete Relevant Parameter Change records and Change Status
As a responsible owner with the appropriate permissions to carry out a final review and complete the review of relevant audit trail parameter change record, you can review the relevant parameter change record in Reviewed status and then assign an appropriate Change Status.
Figure 32: Relevant Parameter Change Record Line Item in Reviewed Status
Click on a line item to see the details of that audit trail parameter change record.
Figure 33: Relevant Parameter Change Record Details Page - Status Reviewed (2)
Review the relevant audit trail parameter change record in Reviewed status and select Change Status to action the appropriate next step.
Figure 34: Select Status Change Action (2)
There are two Change Status options available when the relevant parameter change record is in Reviewed status.
Or
Selecting Complete will result in a pop-up window being presented to allow you to finalise the Change Status action.
Figure 35: Complete Change Status Action Complete
Before you finalise the Complete Change Status action you must confirm that you have reviewed the audit trail parameter change record by checking the tick box and entering your password. Click Confirm if you want to complete the action, this allows for an official e-Signature to be recorded against the Confirm action. Click Cancel if you want to cancel the action.
Confirming will Change Status from Reviewed to Complete.
It is important to note that when a relevant audit trail parameter change record status is Complete, the status and the relevant parameter change record are locked. This means that the relevant parameter change can no longer be changed or updated and is retained as a regulatory record.
Figure 36: Relevant Parameter Change Record Details Page - Status Complete (1)
Responsible owner(s) will receive an automatic email notification, letting them know that a Status Change has occurred on a relevant audit trail parameter change record, and it is approved and complete.
Selecting the Change Status option Incomplete will result in a pop-up window being presented to allow you to finalise the Change Status action.
Figure 37: Complete Change Status Action to Incomplete (2)
Before you complete the Incomplete Change Status action you must provide a justification as to why you are reverting the Status from Reviewed to Incomplete.
Click Confirm if you want to complete the action for Change Status to Incomplete and the justification will be recorded in the Relevant Parameter Change record details. Click Cancel if you want to cancel the action.
Confirming will Change Status from Reviewed to Incomplete.
A responsible owner with the appropriate permissions to update relevant audit trial parameter change records will receive an automatic email notification, letting them know that a Status Change has occurred on a relevant audit trail parameter change record, and it is ready to be updated.
A responsible owner with the appropriate permissions to update relevant parameter change record data, will see a Justification for Change of Status note in the Relevant Parameter Change record details.
Figure 38: Justification Note (2)
A responsible owner with the appropriate permissions to update relevant parameter change record data should respond appropriately, Save the updates and Change Status.
Once all concerns are answered the Relevant Parameter Change record can move forward to completion.
Once a relevant audit trail parameter change record receives a Complete status it is locked within VIEW ATReview and available for review in read-only mode.
Figure 39: Relevant Parameter Change Record Line Item in Complete Status
6.7 Relevant Parameter Change Record Activity Log
Every activity or action that has taken place against a relevant audit trail parameter change record within the VIEW ATReview application is recorded. The activity log associated with an individual relevant parameter change record can be accessed from the Activity Log.
Figure 40: Relevant Change Parameter Record Activity Log
Select the Activity Log tab: A complete history of activity for the selected relevant audit trail parameter change record is documented. The type of activity is coloured coded for ease of visibility.
Figure 41: Relevant Parameter Change Record Activity Log Tab
The Activity Log records Who performed the action within VIEW ATReview (attributable user), When they performed it and What they did on that relevant audit trail parameter change record.
For an alternative, collapsed view of the history of activity for an audit trail relevant parameter change record, select See Details. You can expand out the detail of each activity line item as needed.
Figure 42: Activity Log
An important prerequisite to ensuring that relevant audit trail parameter change records can be captured in VIEW ATReview is the need to register GxP systems. The relevant audit trail parameter change records that you wish to analyse, and review, must be linked to registered systems in ATReview.
Select the System Registry menu item to see a list of registered systems.
Figure 43: System Registry Summary Page
Each registered system can have an associated ID, System Name, IP, Asset ID, Serial Number, Business Owner and System Owner.
COLUMN HEADING
DESCRIPTION
ID (System ID)
The VIEW ATReview application assigns an ID to every system registered. This ensures that each registered system within VIEW ATReview can be uniquely identified.
System Name
A text description that helps identify the system registered. Usually describing the type of system and maybe its location within the manufacturing site.
IP
The IP address of the system on the network so that we can identify the system (or more specifically its network interface) and the location of the system in the network.
Asset ID
A unique asset (system) identifier. Sometimes this is referred to as an asset Tag Number or System Number.
Serial Number
A unique identifier associated with a system. Sometimes this is referred to as a Tag Number or System Number.
Business Owner
A named person responsible for the correct process operation of a system to ensure product quality and adherence to regulatory requirements.
System Owner
A named person responsible for ensuring a system process is executed as requested, that the system is maintained, and that user access is controlled.
Table 5: System Registry - Column Headings
7.1 Responsible Owners and Users
In life science organizations, a system owner is normally a named person responsible for ensuring a system process is executed as requested, that the system is maintained, and that user access is controlled. ATReview requires that every system registered has an assigned responsible System Owner.
- A system owner is the only user with permission to edit a relevant parameter change record.
- A system owner is responsible for completing any incomplete relevant parameter change record.
- A system owner is the only user with permission to change a relevant parameter change record status from Incomplete to For Review.
In life science organizations, a business owner is normally a named person responsible for the correct process operation of a system to ensure product quality and adherence to regulatory requirements. ATReview requires that every system registered has an assigned responsible
Business Owner.
- A business owner does not have permission to edit a relevant parameter change record.
- A business owner is notified when a relevant parameter change record is ready For Review.
- A business owner has permission to change the status of a relevant parameter change record from For Review to Reviewed.
-
A business owner has permission to change the status of a relevant parameter change record from For Review to Incomplete if they feel the system owner has failed to meet the criteria to allow for a status change to Reviewed.
In life science organizations, the Quality Unit is normally responsible for ensuring the appropriate processes are in place and being followed by responsible owners like business owners and system owners. They are also responsible for ensuring changes to relevant GxP data has the correct approvals and sufficient evidence. It is their responsibility to enforce quality checks and standards that underpin an organization’s quality policy. ATReview requires that trained and qualified quality personnel are onboarded and allocated quality unit user permissions in the application.
- A quality unit user does not have permission to edit a relevant parameter change record.
- A quality unit user is notified when a relevant parameter change record is Reviewed.
- A quality unit user has permission to change the status of a relevant parameter change record from Reviewed to Complete.
-
A quality unit user has permission to change the status of a relevant parameter change record from Reviewed to Incomplete if they feel the system owner and business owner have failed to meet the criteria to allow for a status change to Complete.
An Admin user is responsible for system and non-attributable user configuration within ATReview. ATReview requires that trained and qualified admin personnel are onboarded and allocated admin user permissions in the application.
- An Admin user has permission to Add and Edit Systems in the System Registry.
- An Admin user has permission to Add and Edit Non-Attributable Users in the Non-Attributable Registry.
- An Admin user does not have permission to edit a relevant parameter change records.
- An Admin user does not have permission to change the status of a relevant parameter change record.
In life science organizations, there is a group of qualified people who are responsible for ensuring an organization’s audit trail review process is being carried out suitably, consistently and in line with regulatory expectations. These people are often regulatory auditors, and they need access to an organization’s evidence of compliance. ATReview allows for view-only users to be onboarded to support 3rd party requests for access to evidence and compliance.
7.2 How to add a system and responsible owners
Select the System Registry menu item on the main navigation to see a list of registered systems. Within the System Registry summary page, an Admin user can select Add System.
Figure 44: Add System to System Registry
Figure 45: Register New System
When adding a new system to VIEW ATReview there are several mandatory fields which must be completed to ensure the most important information is captured for a particular registered system. This mandatory information distinguishes one system from another and enforces responsible owners for each registered system.
MANDATORY FIELDS
DESCRIPTION
System Name
A text description that helps identify the new system registered. The chosen System Name must be unique. Usually describing the type of system and maybe its location within the manufacturing site.
Asset ID or Serial Number
A unique ID must be applied when registering a new system. The fields Asset ID and Serial Number allow for a unique ID to be registered against a new system (sometimes this is referred to as a Tag Number or other). You do not need to complete both fields, but at least one of these two fields must be completed.
Business Owner
A named person responsible for the correct process operation of a system must be assigned when registering a new system. The Business Owner named will be responsible for reviewing relevant audit trail parameter change records that are in For Review status and changing the status to either Reviewed or Incomplete.
System Owner
A named person responsible for ensuring a system process is executed as requested and that the system is maintained must be assigned when registering a new system. The System Owner named will be responsible for reviewing relevant audit trail parameter change records that are in Incomplete status and changing the status to For Review.
Table 6: New System Registry - Mandatory Fields
When assigning a Business Owner you must select from a list of ATReview authorised and onboarded users. Users that have been onboarded as part of the quality unit group of users will not be permitted to be assigned a Business Owner responsible role.
Figure 46: Assigning a Business Owner
When assigning a System Owner you must select from a list of ATReview authorised and onboarded users. Users that have been onboarded as part of the quality unit group of users will not be permitted to be assigned a System Owner responsible role.
Figure 47: Assigning a System Owner
When you have finished entering in all the new system information, you can click Save and the new system will appear in the System Registry summary page.
Figure 48: New System Added
7.3 How to View and Edit Registered System
All registered systems in VIEW ATReview will appear as line items in the System Registry page.
Figure 49: System Registry - Line Item
Click on a line item to see the details of a registered system.
Figure 50:System Registry - Details Page
As a responsible owner with the appropriate permissions, you can edit the data in the System Registry details page. Click on Edit to update registered system.
The data fields that can be updated are System Name, IP, Business Owner and System Owner. Data fields that cannot be updated are Asset ID, Serial Number, and System ID.
FIELDS AVAILABLE FOR UPDATE
DESCRIPTION
System Name
A text description that helps identify the system registered. Updates can be made, for example, if more specific information is required in this field.
IP
The IP address of the system on the network so that we can identify the system (or more specifically its network interface) and the location of the system in the network. Updates can be made, for example, if the system is moved to another network location.
Business Owner
A named person responsible for the correct process operation of a system to ensure product quality and adherence to regulatory requirements. Updates can be made, for example, if a change of named Business Owner is required because the named Business Owner has left the business.
System Owner
A name person responsible for ensuring a system process is executed as requested, that the system is maintained, and that user access is controlled. Updates can be made, for example, if a change of named System Owner is required because the named System Owner is on annual leave.
Table 7: System Registry Details Available for Update
FIELDS UNAVAILABLE FOR UPDATE
DESCRIPTION
Asset ID
A unique asset (system) identifier. Sometimes this is referred to as an asset Tag Number or System Number. As a unique identifier it is important that it is not changed because it can introduce confusion and impact audit trail records.
Serial Number
A unique identifier associated with a system. Sometimes this is referred to as a Tag Number or System Number. As a unique identifier it is important that it is not changed because it can introduce confusion and impact audit trail records.
System ID
The VIEW ATReview application assigns an ID to every system registered. This ensures that each registered system within VIEW ATReview can be uniquely identified. As a unique identifier it is important that it is not changed because it can introduce confusion and impact audit trail records.
Table 8: System Registry Details Unavailable for Update
Figure 51: System Registry Details Page - Editing
Any updates made to a registered system can be Saved.
7.4 Related Events
While in the System Registry details page you can quickly and easily see a summary of all relevant audit trail parameter change records related to that system. Go to the Related Parameter Changes field and click See Details.
Figure 52: System Registry - Related Parameter Changes
All relevant parameter change records related with that system will be presented.
Figure 53: System Registry - Related Parameter Changes Example
7.5 System Activity Log
Every activity or action that has taken place against a registered system within the VIEW ATReview application is recorded. The activity log associated with a registered system can be accessed through the Activity Log field within the registered system details page. Select See Details to see the history of activity for a registered system of interest.
Figure 54: System Registry - Activity Log
The system Activity Log records Who performed the action within VIEW ATReview (attributable user), When they performed it and What they did, for example, added a registered system.
Figure 55: System Registry Activity Log Example
8. Include Relevant Parameter Change Types
The regulations and guidelines stipulate it is “not necessary for audit trail reviews to include every system activity“.
A risk assessment should be performed to determine the relevance of the audit trail data, its importance, and its impact on product quality. The guidelines also state that “the relevance of the data retained in audit trails should be considered by each organisation to permit robust data review/verification…audit trails may be reviewed as a list of relevant data, or by an exception reporting process”.
The purpose of the Inclusion Registry is to register within ATReview the type of data (or Relevant Parameter Changes) that the organisation has identified as relevant for audit trail analysis and review.
The types of relevant data (or Relevant Parameter Changes) are configured during setup as Rules in the ATReview application. This registration is performed by the Odyssey VC team and cannot be modified without the raising of a change request.
Figure 56: Inclusion Registry
8.1 Inclusion registry
The Inclusion Registry is a view-only summary of all relevant parameter changes that the organisation has identified as relevant for audit trail analysis and review.
COLUMN HEADING
DESCRIPTION
Rule
The type of relevant parameter change that the organisation has identified as relevant for analysis and should be included for audit trail review. A system audit trail parameter change record, that contains this relevant parameter change, is logged as a Relevant Parameter Change record in ATReview.
Description
A description of the relevant parameter change registered in the VIEW ATReview Inclusion Registry.
System
The system that owns the relevant parameter change registered in the Inclusion Registry.
Start Date
The date that the ATReview application will start to include the type of relevant parameter change for analysis and review.
End Date
The date that the ATReview application will end including the type of relevant parameter change for analysis and review.
Owner
The person responsible for approving the inclusion of a type of relevant parameter change in the Inclusion Registry. The responsible person is within the regulated organisation.
Rationale
A reason outlining why this type of relevant parameter change has been identified as relevant by the organisation and included in the Inclusion Registry.
Table 9: Inclusion Registry - Column Headings
9. Register Non-Attributable Users
The ATReview application can register non-attributable users. The advantage of registering non-attributable users is that the ATReview application can automatically check Relevant Parameter Change records for these registered non-attributable users. If a registered non-attributable user is detected, ATReview will automatically bring it to attention by highlighting it in red and requiring you to correct it.
Select the Non-Attributable menu item to see a list of registered non-attributable users.
Figure 57: Non-attributable summary page
Registered non-attributable users will be listed in the non-attributable users’ summary page. Each non-attributable user registered will have a unique ATReview ID, identifiable Non-Attributable User text and associated Description.
COLUMN HEADING
DESCRIPTION
ID
The VIEW ATReview application assigns an ID to every non-attributable user registered. This ensures that every registered non-attributable user within VIEW ATReview can be uniquely identified.
Non-Attributable User
User data that is not capable of being attributed to a specific person or system.
Description
A description giving details of the non-attributable user registered and possible rationale why this non-attributable user should be highlighted if it is found in any relevant parameter change record.
Table 7: Non-attributable - column headings
9.1 How to Add a Non-Attributable User
Select the Non-Attributable menu item on the main navigation to see a list of non-attributable users. Within the Non-Attributable summary page, you can select Add User.
Figure 58: Non-Attributable - Add User
Figure 59: Add User Details Page
When adding a new non-attributable user to VIEW ATReview the mandatory fields of Non-Attributable User and Description must be completed to ensure the most important information is captured for the non-attributable user.
When you have completed the new non-attributable user mandatory fields, you can click Add and the new Non-Attributable User will appear in the Non-Attributable summary page.
Figure 60: Non-Attributable - New User
9.2 How to view and edit non-attributable users
All registered non-attributable users in VIEW ATReview will appear as line items in the Non-Attributable summary page.
Figure 61: Non-Attributable User - Line Item
Click on a line item to see the details of a non-attributable user.
Figure 62: Non-Attributable Details Page
As a responsible owner with the appropriate permissions, you can edit the data in the Non-Attributable Users details page. The Non-Attributable User field and the Description field are available for update.
Figure 63: Non-Attributable Details Page - Editing
Any updates made to a non-attributable user can be Saved.
9.3 Non-Attributable User Activity Log
Every activity or action that has taken place against a non-attributable user within the VIEW ATReview application is recorded. The activity log associated with a non-attributable user can be accessed through the Activity Log field within the Non-Attributable Users details page. Select See Details to see the history of activity for a non-attributable user of interest.
Figure 64: Non-Attributable Activity Log
The non-attributable Activity Log records Who performed the action within VIEW ATReview, When they performed it and What they did, for example, updated the description field.
ATReview keeps a chronological record of all actions and activities that take place within the application in its Activity Log.
The recording of all actions and activities, whether automated or manual, is invaluable for supporting compliance, problem analysis and the reconstruction of events. The activity records in ATReview cannot be changed, removed, or deleted.
Select the Activity Log menu item to see a list of all actions and activities.
Figure 65: Activity Log - Summary Page
All actions and activities both automated and manual will appear as line items in the Activity Log summary page. The default view mode is collapsed for each line item in the Activity Log.
For each activity recorded in the Activity Log you will see, in the collapsed view mode, an associated Entity ID, Entity, Attributable User, Date & Time Stamp and Action Type.
COLUMN HEADING
DESCRIPTION
Entity ID
The VIEW ATReview application assigns an Entity ID to every action or activity that is recorded in the Activity Log. This ensures that each individual activity within VIEW ATReview can be uniquely identified.
Entity
All action and activities are automatically divided into distinct entities (core source activity types) by ATReview. This gives easy visibility of the entity to which each action or activity belongs.
The Entity divisions in the Activity Log are:
Parameter Change
System
Non-attributable User
Attributable User
When a User of ATReview or the ATReview application itself performs any action or activity, the attributable details (person or system identity) of who performed that action or activity is recorded.
Date & Time Stamp
When a User of ATReview or the ATReview application itself performs any action or activity, the date & time of when that action or activity took place is recorded.
Action Type
All action and activities in ATReview are automatically categorised into Action Types (tied to an Entity) by the ATReview application, for easy visualisation, searching, sorting and/or filtering.
The Action Type categories in the Activity Log are:
Created Parameter Change
(Parameter Change)
Modified Parameter Change
(Parameter Change)
Status Changed
(Parameter Change)
Created System
(System)
Modified System
(System)
Created Non-Attributable User
(Non-attributable User)
Modified Non-Attributable User
(Non-attributable User)
Deleted Non-Attributable User
(Non-attributable User)
Table 11: Activity Log – Column Headings
You can see an expanded detailed view of each activity log line item by clinking on the down arrow on the left-hand side.
Figure 66: Activity Log Line Item - Expanded View
11. Exporting data to Excel Reports
You can export the data of Relevant Parameter Change Records, System Registry, Non-Attributable and Activity Log main summary pages and make this data available as reports in Microsoft Excel.
11.1. Relevant Parameter Change Report
On the main navigation bar select Parameter Changes. To the right-hand side, on top of the summary page you will see Export.
Figure 67: Export to Relevant Parameter Change Report
Click on Export.
A Microsoft Excel report will be made available.
Figure 68: Download Relevant Parameter Change Records Report
The reports exported will reflect the column headings and associated data that is available in the Relevant Parameter Change records summary page, that is, any data available under ID, Status, Attributable User, Data and Time Stamp, System, Setting (Old Value, New Value) and Reason.
The reports will reflect any Search, Filter and/or Sort refinements applied in VIEW ATReview application.
The exported report is limited to 10,000-line items i.e., the maximum number of relevant parameter change records that can be exported to a report is 10,000. Please note, that larger exported reports will take a little bit of time to download.
Figure 69: Relevant Parameter Change Records Report - MS Excel
*Note: The reports produced through the Export feature in ATReview should not be considered GxP compliant reports as they do not have sufficient controls in place to assure data integrity.
11.2. System Registry Report
On the main navigation bar select System Registry. To the right-hand side, on top of the summary page you will see Export.
Figure 70: Export System Registry Report
Click on Export.
A Microsoft Excel report will be immediately available.
Figure 71: Download System Registry Report
The reports exported will reflect the column headings and associated data that is available in the System Registry summary page, that is, any data available under System ID, Name, IP, Asset ID, Serial Number, Business Owner and System Owner.
The reports will reflect any Search refinements applied in VIEW ATReview application.
The exported report is limited to 10,000-line items i.e., the maximum number of system registry line items that can be exported to a report is 10,000. Please note, that larger exported reports will take a little bit of time to download.
Figure 72: System Registry Report - MS Excel
*Note: The reports produced through the Export feature in ATReview should not be considered GxP compliant reports as they do not have sufficient controls in place to assure data integrity.
11.3. Non-Attributable Report
On the main navigation bar select Non-Attributable. To the right-hand side, on top of the summary page you will see Export.
Figure 73: Export to Non-Attributable Users Report
Click on Export.
A Microsoft Excel report will be made available.
Figure 74: Download Non-Attributable User Report
The reports exported will reflect the column headings and associated data that is available in the Non-Attributable summary page, that is, any data available under ID, User and Description.
The reports will reflect any Search refinements applied in VIEW ATReview application.
The exported report is limited to 10,000-line items i.e., the maximum number of system registry line items that can be exported to a report is 10,000. Please note, that larger exported reports will take a little bit of time to download.
Figure 75: Non-Attributable User Report - MS Excel
*Note: The reports produced through the Export feature in ATReview should not be considered GxP compliant reports as they do not have sufficient controls in place to assure data integrity.
11.4. Activity Log Report
On the main navigation bar select Activity Log. To the right-hand side, on top of the summary page you will see Export.
Figure 76: Export to Activity Log Report
Click on Export.
A Microsoft Excel report will be made available.
Figure 77: Download Activity Log Report
The reports exported will reflect the column headings and associated data that is available in the Activity Log summary page, that is, any data available under Entity ID, Entity, Action Type, Changes, User, Date.
The reports will reflect any Search, Filter and/or Sort refinements applied in VIEW ATReview application.
The exported report is limited to 10,000-line items i.e., the maximum number of system registry line items that can be exported to a report is 10,000. Please note, that larger exported reports will take a little bit of time to download.
Figure 78: Activity Log User Report - MS Excel
*Note: The reports produced through the Export feature in ATReview should not be considered GxP compliant reports as they do not have sufficient controls in place to assure data integrity.
12. Support Centre
At the bottom of the main navigation (bottom left-hand side) you will see a feature which gives access to the VIEW Support Centre.
Figure 79: Support Centre - Access
Click on Documentation to be brought to the VIEW Support Centre
Figure 80: Support Centre - Homepage
You can either Search for most relevant documents or Browse help articles.
Figure 81: Support Centre - Solutions
The support centre empowers you to source the answers you need by providing you access to VIEW FAQs, Legal documents as well as User Documentation.