Understanding Validated Archiving Systems in Pharma and Life Sciences

Often, when we hear the term “validated archiving system” within pharma and life sciences, it’s easy to assume it refers to an archive tailored specifically to all GxP data. But we need to ask ourselves, what does it mean to have a validated system, and how does the system meet specific archiving needs?

What is a Validated System?

A validated system in the context of pharma and life sciences is a system that has been thoroughly tested and documented to ensure it operates according to its intended purpose, meets regulatory requirements, and produces reliable and consistent results. Validation is a formal process that includes the design, installation, operation, and performance qualifications (commonly referred to as IQ, OQ, and PQ). The goal is to provide documented evidence that the system consistently performs as expected.

The Importance of Validation

Validation is particularly important in pharma and life sciences, it supports compliance with stringent regulatory standards such as those set by the FDA, EMA, and other global regulatory bodies. It also helps organisations to tackle the ongoing challenges such as ensuring data integrity and managing risk.

Selecting a System to Meet Your Needs

While all systems can be validated, the choice of system depends heavily on your key requirements. The analogy of sports equipment helps to illustrate my point: cricket, badminton, and baseball all use bats, but each sport requires a bat designed for its specific demands, e.g. you wouldn’t play badminton with a cricket bat. Similarly, a validated archiving system must be selected based on the specific needs of your organisation.

Key Considerations for Selecting an Archiving System

1. How Long Do I Want to Keep My Data?

Having a clear idea of how long you need to retain your data has a significant impact on the type of validated archive you will need.

There are validated archives which are perfectly suited for short-term storage. However, if you are looking to archive Trial Master Files (eTMFs), which require a minimum retention period of 25 years, a long-term archiving and preservation solution is better suited. This type of system provides robust safeguards against corruption or loss and preserves the data for future use. There are also financial implications relating to retention periods. Short-term solutions might offer lower upfront costs, but for extended archiving needs, options with a lower Total Cost of Ownership (TCO) could be more economical.

2. How Often Do I Need to Access My Data?

Consider how often you’ll need to retrieve archived data. Your access requirements can significantly influence your choice of archiving solution.

If you rarely need access to your archived data, a live system that will lock in the data for a specified period may suffice. However please be aware that if your circumstances change and the data needs to be moved or replaced with an updated version, there may be additional fees. For data that is frequently being accessed e.g. multiple stakeholders accessing past data for ongoing vaccine development, you’ll need a more dynamic system with efficient retrieval capabilities.

3. Is My Data Subject to Inspection?

You may evaluate whether the archiving system requires the functionality to support an inspection.

For data unlikely to face inspection or audit, a basic archiving solution might be adequate. However, if you’re dealing with critical GxP data that could be examined by regulators in the future, it’s important to select a system that aligns with industry guidelines and regulatory expectations. A good example is audit trails, an inspector is likely to ask for a full audit trail of your data, but not all validated archives support this feature.

Conclusion

Selecting a validated archiving system in pharma and life sciences is not a one-size-fits-all decision. A system’s ability to be validated does not guarantee it will meet your organisation’s specific needs. It is important to thoroughly map out the requirements of all stakeholders within your organisation. Failing to perform this evaluation could result in non-compliance and put your data at risk.

Further Information

If you would like to learn more about the process of selecting the right archival partner our webinar recording is available which highlights how Cervel Therapeutics navigated this challenge.

Arkivum is also hosting a live webinar on Thursday 22^nd August at 2pm BST/9am EST titled Selecting the Right Long-Term Archiving Solution for Your GxP Data. If you would like to learn more, please register for the event.