Third Party Audit Concludes ValSuite Pro is Designed to Ensure Data Integrity

To ensure compliance, the audit was performed in accordance with all relevant regulations and guidelines:

• 21 CFR Part 11
• EU Annex 11
• WHO: Guideline on Data Integrity
• MHRA: GXP Data Integrity Guidance and Definitions
• ISPE: Records and Data Integrity Guide
• ISPE: Data Integrity, Key Concepts
• FDA: Data Integrity and Compliance with cGMP Guidance for Industry
• PDA: Technical Report 80: Data Integrity Management System for Pharmaceutical Laboratories
• PIC/S: Good Practices for Data Management and Integrity for GMP/GDP Environments
• EMA: Data Integrity Q&A

Ellab’s ValSuite Pro system was thoroughly checked and tested, and the areas that required compliance quickly became clear:

• Raw data cannot be deleted by any users in the software, this includes system administrators
• The software contains no functional limit on the number of user logins and electronic signatures, which eliminates the need for shared logins
• The audit trail is user-friendly for review and cannot be toggled on/off
• The software is capable of setting up user roles with appropriate permissions, so that anyone with a direct interest in the data is unable to delete or alter records
• There are data backup functions present within the software

In conclusion, the audit noted that ValSuite Pro ensured data integrity, though it in some cases came down to the user to utilize the software appropriately for complete compliance. Which is to be expected given that users have to determine the roles of the operators. So all in all a very positive result.