Note: Audit trails for Administrative, Change Control module, Issues module, and Tasks module activities can be independently viewed and exported through the application.

 

ZenQMS understands the regulatory requirements of its clients regarding audit trail reviews, and is here to accommodate and support its clients. The audit trail review process is  a crucial requirement to ensure data integrity and regulatory compliance in GxP systems. The purpose of audit trail review is to verify the accuracy, reliability, and traceability of data generated within GxP-regulated systems. It helps demonstrate that data has not been tampered with, provides transparency in data handling, and enables the reconstruction of events or actions that have occurred during the data lifecycle.

 

Audit trails will contain a large amount of data, therefore we recommend you define the scope of the review and adopt a sampling approach: Select a representative sample of transactions or activities to review in detail, ensuring that it covers various scenarios and time periods. This is why we are offering a standardized set of reports for you. We’ve done the work for you and can provide the following ZenQMS Standardized Audit Trail Reports. Just email us a help@zenqms.com and make the request.

 

If you require more, we ask that you provide exact and short time frames, and a specific or group of records, and the purpose of the review so we can pull the data that is in the scope of your review.

 

Audit Trail Reports

 

Users Added & Disabled

Description:  This audit trail report will generate a list of transactions showing all users added or disabled within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • table_name - name of database table affected
  • action - U = update, I = insert
  • User Name - user affected in transaction
  • is_active - t = true, f = false
  • is_invited - t = true, f = false
  • changed_fields - fields/data updated in transaction

 

Users Added or Removed from Roles

Description:  This audit trail report will generate an audit trail of transactions showing all users added or removed from roles within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • User Name - user affected in transaction
  • Role Name - role affected in transaction
  • Role Description - description of role affected by transaction
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Role Changes

Description:  This audit trail report will generate an audit trail of transactions showing any name or description changes made to roles within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • action - U = update, I = insert
  • table_name - name of database table affected
  • Role Name (New) - role affected in transaction
  • Description  (new) - description of role affected by transaction
  • Role Name - role affected in transaction
  • Description - role description found within the application
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Document Journey

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to documents within the last 14 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • table_name - name of database table affected
  • Action - I = insert, U = update
  • Document ID - document ID of document in transaction
  • Document Name - document name of document in transaction
  • Document Version # - version number of document in transaction
  • Document Category - document category of document in transaction
  • Document State - document state of document in transaction
  • Description (if present/applicable) - document description of document in transaction
  • Author User #1 - author name of document in transaction
  • Author User #2 - author name of document in transaction
  • Author User #3 - author name of document in transaction
  • Version Comments (if applicable) - version comments of document in transaction
  • Workflow Users (if present) - workflow users of document in question
  • Date Approved (utc) - document approval date of document in transaction
  • Date Effective (utc) - effective date of document in transaction
  • Date Retired (utc) - retirement date of document in transaction
  • Date of Next Review (utc) - nest review date of document in transaction
  • Is Current? - is document current, Yes or No
  • Review Interval (months) - document review interval of document in transaction, 0 = never
  • Retraining Interval (months) - document retraining interval of document in transaction, 0 = never
  • Is Training Document? - Yes or No
  • File Name - file name of document in transaction
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Document Assignments

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to a document’s training assignments within the last 90 days. 

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • Document ID - document ID of document in transaction
  • Document Name - document name of document in transaction
  • User Name - user name of user affected by transaction
  • Role Name - role name of role affected by transaction
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Document Attachments

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to document attachments within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • Document ID - document ID of document in transaction
  • Document Name - document name of document in transaction
  • Document Version # - version number of document in transaction
  • File Name - file name of document in transaction
  • Is Current? - is document current, Yes or No
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Document Changes

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to documents within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • Document ID - document ID of document in transaction
  • Document Name - document name of document in transaction
  • User Name - user name of user affected by transaction
  • Role Name - role name of role affected by transaction
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Document Workflow and Versions

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to document workflows and versions within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • table_name - name of database table affected
  • audit_login - user executing the transaction
  • Document ID - document ID of document in transaction
  • Document Version # - version number of document in transaction
  • Document Name - document name of document in transaction
  • Version Comments (if applicable) - version comments of document in transaction
  • Workflow Users (if present) - workflow users of document in question
  • Document State - document state of document in transaction
  • Selected Approver User Name - user name of approver in workflow
  • Actual Approver User Name - user name of user completing workflow step
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Training Course Changes

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to training courses within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • Course ID - training course ID in the transaction
  • Course Name (new) - new course name if updated in transaction
  • Course Name - current course name in transaction
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Training Course Documents

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to a training course document syllabi within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • Course ID - training course ID
  • Course Name (new) - new course name if updated
  • Course Name - current course name
  • Document ID - document ID of document in transaction
  • Document Name - document name of document in transaction
  • Comment (new) - new comment in training course in transaction
  • Comment - current comment on training course in transaction
  • Syllabus Order # - order number of document in training course in transaction
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Training Course Training Events Added or Removed

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to training course events within a training course syllabi within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • Course ID - training course ID
  • Course Name - course name if updated
  • Training Event ID - training event topic of training event in transaction
  • Is OJT? - Yes, only OJT events can be added to courses
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Training Course Assignments

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to training course assignments within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • Course ID - training course ID
  • Course Name - course name if updated
  • User Name - user name of user in transaction
  • Group/Role Name - name of group/role in transaction
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Training Event Changes

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to training events within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • Training Event ID - training event ID of training event in transaction
  • Organizer User #1 - training event organizer name
  • Organizer User #2 - training event organizer name
  • Organizer User #3 - training event organizer name
  • Is Personal Event? (new) - is the training event a personal event, 0 = no, 1 = yes
  • Date (new) - training event date new
  • Date - training event date
  • Instructors (new) - new training event instructors, new
  • Instructors - training event instructors
  • Description (new) - training event description, new
  • Description - training event description
  • Venue (new) - training event description, new
  • Venue - training event description
  • Credits (new) - training event credits, new
  • Credits - training event credits
  • Time (new) - training event time, new
  • Time - training event time
  • Is OJT? (new) - is this training event an OJT event, 0 = no, 1 = yes
  • Is OJT? - is this training event an OJT event, 0 = no, 1 = yes
  • Training Grace Period (new) - training event training grace period in days, new
  • Training Grace Period - training event training grace period in days, new
  • Retraining Interval (months) (new) - training event retraining interval in months, new
  • Retraining Interval (months) - training event retraining interval in months
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction

 

Training Event Assignments

Description:  This audit trail report will generate an audit trail of transactions showing all changes made to a training event’s user/role assignments within the last 90 days.

Key:

  • action_tstamp_tx - timestamp of database transaction
  • transaction_id - unique identifier for transaction
  • summary - summary of transaction
  • audit_login - user executing the transaction
  • Training Event ID - training event ID of training event in transaction
  • Training Event Topic - training event topic of training event in transaction
  • User Name - name of user in transaction
  • Group/Role Name - group/role name in the training event affected by transaction
  • Changed Fields (raw data) - fields/data updated in transaction
  • Row Data (current) - current data linked to this transaction




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