This eBook has attempted to do three key things.

1. Firstly, the importance of taking a long-term and risk-based approach to Data Integrity can’t be understated, which is key to specifying that systems need to be fit for this purpose. This specification should be used to drive the process of selecting, validating and using systems that are demonstrably suitable for long-term retention and archiving of GxP records and data.
2. Secondly, a suitable validation pack can be instrumental in providing evidence of that systems are indeed fit for this purpose, including how both long-term Data Integrity will be met and GxP regulations and guidelines will be supported. This is how we approach the Traceability Matrix in the Arkivum validation pack, which shows that our solution is fit for purpose for long-term retention and archiving of GxP data. This includes: (a) how the solution is designed to meet a wide range of GxP regulations and guidelines, (b) how this can be demonstrated through mappings to specific product features and executed tests, and (c) support for a risk-based approach to validation that focusses on what aspects of the solution are most critical to Data Integrity, Data Confidentiality and Data Privacy.
3. Thirdly, monitoring and oversight is a key part of ensuring systems really are fit for purpose in practice and long-term Data Integrity has been measurably maintained. This is essential to demonstrating that risks have been properly managed and that the system and supplier is doing the job they should be. Specifying the need for this in the URS means proper monitoring and oversight features will be included as part of the chosen supplier and system.

At Arkivum we find that a traceability matrix approach of mapping regulatory requirements and guidelines to product features makes a huge difference to each of these three areas. Validation is essential to ensuring ‘fit for purpose’ regulatory compliance. For example, if a client has a URS that contains specific archiving and retention requirements that their organisation has identified, then these can be easily mapped to corresponding Arkivum product features and from there to the GxP regulations and guidelines that are being met.

Likewise, if a client has a URS that specifies what GxP regulations and guidelines must be followed, then the traceability matrix shows exactly how those regulatory requirements are met by specific Arkivum product features. So either way around, if the question is ‘demonstrate that the system is fit for purpose’, then the traceability matrix and executed tests can be used to provide the answer.