When working in regulated environments — especially in life sciences — it’s not enough to just store your data. You must store it in a way that ensures it can be read, interpreted, and audited years down the line. This is more than a best practice — it’s a regulatory requirement.
What’s the Regulation?#
This requirement comes from 21 CFR Part 11, which governs electronic records and signatures. Specifically:
- 21 CFR 11.10(c) requires that records are “accurate and ready for retrieval” throughout their retention period.
- The FDA’s 2018 guidance on data integrity reinforces that if records are stored in non-human-readable or proprietary formats, companies must retain the software or system needed to render them readable.
If you save data in a format that only your application can read, you must keep that application around — or make sure the data is also available in a human-readable format.
This ensures that critical records don’t become inaccessible just because the original software is obsolete.
What About Global Regulations?#
This principle isn’t unique to the U.S. The EU GMP Annex 11 says the same:
“If the system is no longer supported, data should be migrated to a supported system or maintained in a way that is readable.”
In other words, accessibility, integrity, and readability over time are non-negotiable — even if your systems evolve.
What Should You Do?#
- Retain readable exports (e.g., PDFs, CSVs) alongside raw data whenever possible
- Document how to interpret data stored in custom or proprietary formats
- Keep legacy applications or emulators if needed, or plan for timely data migration
Bottom Line#
Regulations don’t just care that you kept the data — they care whether you (or an auditor) can actually understand it years later. If it’s locked away in a black box, you’re on shaky ground.
Need help aligning your records retention with regulatory expectations? Reach out to your compliance or quality team — or let us know how we can help.