Why You Must Keep Data Human-Readable — Even Years Later

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This ensures that critical records don’t become inaccessible just because the original software is obsolete.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.