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

Fri, 11 Apr 2025 00:00:00 +0000

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.

Introduction to Pharmaceutical Regulations & Guidelines

Fri, 11 Apr 2025 00:00:00 +0000

The pharmaceutical industry operates within one of the most highly regulated environments in the world. Regulations and guidelines are essential to ensure that medicines are safe, effective, and of the highest quality—protecting patients and supporting public health. These requirements span every stage of the drug lifecycle, from discovery and development to manufacturing, distribution, and post-market surveillance.

Why Regulations Matter#

Regulatory frameworks are designed to:

Safeguard patient safety and product efficacy
Ensure data integrity and transparency
Promote consistency and quality in manufacturing and clinical practices
Enable global harmonization and efficient market access

Key Regulatory Areas#

This section introduces the major regulatory domains that shape pharmaceutical practice:

21 CFR Part 11 on STEM to STEAM

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

What’s the Regulation?#

Introduction to Pharmaceutical Regulations & Guidelines

Why Regulations Matter#

Key Regulatory Areas#