Documentation Requirements for Record-Keeping in Manufacturing: What You Must Get Right

When a medicine batch fails, it’s rarely because the formula was wrong. More often, it’s because someone forgot to sign off on a temperature log, or a machine ID wasn’t recorded, or a handwritten note got smudged. In manufacturing-especially in pharma, medical devices, and food-documentation isn’t paperwork. It’s your last line of defense against contamination, mix-ups, and recalls that can cost millions-or worse, lives.

Why Documentation Isn’t Optional

The 1937 Elixir Sulfanilamide tragedy killed 107 people because no one tested the solvent used. That disaster led to the first real GMP rules. Today, those rules are written into law. In the U.S., it’s 21 CFR Part 211. In Europe, it’s EudraLex Volume 4. In 56 countries, it’s PIC/S guidelines. These aren’t suggestions. They’re legal requirements.

If your records don’t meet the standard, regulators don’t just give you a warning. They issue Form 483 observations. They send warning letters. They shut down production. In 2022, Stericycle reported that a single recall due to poor documentation cost manufacturers an average of $10 million. That’s not a typo. Ten million dollars.

And it’s not just about money. A 2021 FDA analysis found that 87% of warning letters cited data integrity failures. That means most compliance issues aren’t about dirty floors or broken equipment. They’re about missing, late, or altered records.

What Gets Documented: Two Types of Records

There are two kinds of records you need: procedural documents and compliance records.

Procedural documents are your instructions. These include:

• Standard Operating Procedures (SOPs) written in active voice-no "it should be done," just "the operator shall verify temperature before starting."
• Testing methods validated under ICH Q2(R1) guidelines
• Emergency protocols for equipment failure or contamination events
• Material specs with exact tolerances: "moisture content: 3.5% ± 0.2% w/w"
• Bills of materials with unique IDs for every component

Compliance records are the proof you followed those instructions. These must follow the ALCOA+ principles:

• Attributable-Who did it? Name, signature, date, time.
• Legible-Readable now and in 10 years. No pencil, no smudges.
• Contemporaneous-Recorded at the time of the activity. Not later. Not the next day.
• Original-The first data captured. Not a copy, not a transcription.
• Accurate-No guessing. No rounding unless allowed.
• Complete-All data, even the "failed" results.
• Consistent-No contradictions between logs, forms, or reports.
• Enduring-Stored securely for at least one year after product expiry.
• Available-Accessible for audits, inspections, investigations.

Electronic Systems: The New Normal

Paper records are fading. Most manufacturers now use electronic quality management systems (eQMS). But switching isn’t just installing software. It’s validating the whole system.

Under GAMP 5 guidelines, every electronic system must be validated with over 150 test cases. That includes:

• Can users only access what they’re authorized to?
• Is there a full audit trail that can’t be deleted?
• Do electronic signatures meet 21 CFR Part 11? That means identity verification, unique login, and timestamped actions.
• What happens if the server crashes? Is data recoverable?

A 2022 ISPE study found that companies using validated eQMS reduced documentation errors by 55%. Merck, for example, cut their corrective action closure time from 45 days to 22 after switching to MasterControl.

But here’s the catch: 68% of companies lose data during system migrations. Why? Because they skip the 100% data migration validation required by FDA 21 CFR 11.10(g). Don’t be one of them.

Regional Differences That Trip Up Global Manufacturers

You might think GMP is the same everywhere. It’s not.

The FDA requires every calculation to be verified by a second qualified person. The EU lets you use automated verification. Japan requires all documents to be in Japanese for local submissions. The EU’s MDR 2017/745 demands clinical evaluation reports with specific literature search methods-something the FDA doesn’t require.

A 2022 Emergo by UL study showed manufacturers targeting both the U.S. and EU markets spend 37% longer on approvals just to reconcile documentation. And it costs an average of $2.1 million per year to keep up.

Medical device makers face another layer: ISO 13485:2016 requires design history files with traceability matrices. FDA’s QSR doesn’t. So if you make a device and sell it in both markets, you’re writing two versions of the same thing.

What Goes Wrong (And How to Fix It)

The Parenteral Drug Association’s Technical Report No. 60 breaks down the top four documentation failures:

• 42%: Records created after the fact, not during the activity
• 29%: Investigations lack detail-"something went wrong" isn’t enough
• 18%: Original data lost or replaced with copies
• 11%: Changes to records aren’t properly documented or justified

A 2023 PharmaTrain survey of 452 QA professionals found that documentation tasks take up 68% of their time. And 74% had at least one audit finding in the past year.

The fix? Follow the "5C" rule:

• Clear-No jargon. Write at an 8th-grade reading level. FDA recommends this.
• Concise-No fluff. If it doesn’t affect quality, don’t write it.
• Complete-Every step, every number, every signature.
• Correct-Double-check. Use the four-eyes principle for critical entries.
• Compliant-Always tie back to your SOPs and regulations.

Janssen cut documentation errors by 76% by linking electronic checklists directly to their manufacturing execution system. Real-time validation. No guessing. No delays.

What’s Changing in 2025

Regulators aren’t slowing down. In fact, they’re speeding up.

The European Commission’s 2024 revision of EudraLex will require risk-based documentation by January 2025. That means you must document your own risk assessments for every critical record process. No more blanket rules.

The FDA’s 2023 draft guidance says hybrid systems (paper + electronic) must have audit trails for all electronic entries-with a minimum of 1,000 characters per entry. That’s to prevent people from deleting or editing without a trace.

PIC/S is releasing a new GDocP guide in Q3 2024 to fix regional inconsistencies. And AI is starting to help: early adopters report 45% less time spent on batch records because systems auto-generate them from machine data. But regulators haven’t approved AI-generated records yet. Validation frameworks are still being built.

How to Get Started

If you’re starting from scratch, expect 18 to 24 months to build a compliant system. Budget $1.2 to $2.5 million for implementation.

Start here:

1. Map every process that affects product quality. Write down every step.
2. For each step, define what needs to be recorded and why.
3. Train everyone-not just QA. Operators, maintenance, logistics. Everyone.
4. Choose an eQMS that’s validated and supports audit trails, electronic signatures, and data retention.
5. Assign "documentation champions" in each department. People who know the rules and can answer questions.
6. Review records weekly. Don’t wait for an audit.

Don’t wait for a warning letter to wake you up. The best manufacturers don’t see documentation as a burden. They see it as the foundation of quality culture.