Documentation and Data Integrity Essentials
Most data integrity findings are not fraud. They are ordinary records made a little late, under the wrong login, corrected the wrong way, or reviewed on paper when the truth was in the system.
A short, complete course on the life of one Good Manufacturing Practice (GMP) record as European Union (EU) GMP expects it to run: knowing what a record is and which copy is the original, making the entry at the time and under your own name, correcting it so the original can still be read, reviewing the data and its audit trail rather than the printout, and keeping it readable and protected for as long as it has to last.
Five things you will take back to site
One outcome per lesson. Each is practised in the lesson and tested at the end of it.
- Know what a record is, and which copy is the originalTell an instruction from a record, find where a value was first captured, and use ALCOA++ as ten questions you can ask of any record.
- Make the entry properlyRecord at the time, under your own identity, on a controlled form, with no empty fields and nothing that can be added later.
- Correct it so the original can still be readCorrect paper and electronic records the way EudraLex Volume 4, Part I, Chapter 4 (Documentation) and Annex 11 (Computerised Systems) expect, and recognise when a correction has become a change to the result.
- Review the data, not only the printoutCheck entries against their source, review the audit trail before the data is relied on, and know which record is the original in a hybrid system.
- Keep it trustworthy for as long as it must lastKeep access matched to the job, keep records restorable and readable for their retention period, and raise a data integrity problem openly when you find one.
Structured so that it stays with you
Short courses are usually forgotten within a month. This one is built around the few things that are known to make material stay: hearing it as well as reading it, being asked to recall it, and meeting the same ideas again in a different form.
Narrated throughout
Every topic is narrated, so you can listen and read together, or listen alone. Hearing and reading the same material is one of the simplest ways to make it stay.
Orientation in thirty seconds
Each topic opens with the whole argument in four lines. You know where you are going before you start, which is when new material is easiest to place.
Pause and answer
Every topic stops once and asks you a question about what you have just read, with feedback either way. Recalling something is what fixes it; re-reading it is not.
Three things to remember
Each topic ends with three sentences. Not a summary of everything, but the three things you would want back in six months.
A check at the end of every lesson
Three questions per lesson, then a twenty-question final assessment. Every question is answerable from the three things to remember. Nothing is tested that was not taught.
One case, worked through
A workshop that puts one laboratory result in front of you and four decisions to make in writing, before you see how an experienced reviewer would handle it.
Five lessons, in the order a record lives
Each lesson has three narrated topics and ends with a three-question knowledge check. After Lesson 5 comes the workshop, the final assessment, the job aids, and a short page on what to do in the next few weeks.
| Lesson | Title | What it covers | Basis |
|---|---|---|---|
| 1 | What a GMP record is | Instructions and records, raw data and the original, ALCOA++ as a test, and what the guidance actually says. | Chapter 4, Principle, 4.1 |
| 2 | Making the entry | At the time, under your own name and login, on a controlled form, with no empty fields. | Chapter 4, 4.7, 4.8; Annex 11, 12.4 |
| 3 | Correcting it | Paper corrections, electronic changes and reasons, and where a correction becomes a change to the result. | Chapter 4, 4.9; Annex 11, 9, 12.4 |
| 4 | Reviewing it | The second-person check, audit trail review, and reviewing electronic data rather than the printout. | Annex 11, 6, 8, 9 |
| 5 | Keeping it | Access and identity, retention, backup and archive, and what to do when something goes wrong. | Chapter 4, 4.10, 4.11; Annex 11, 7, 12, 13, 17 |
Who this course is for
Anyone who makes, checks, reviews or approves a GMP record, on paper or in a computerised system. Production, quality control (QC) laboratory, engineering, warehouse and quality assurance (QA). It assumes you work on a GMP site. It does not assume you know anything about computerised systems.
Where it sits in EU GMP
EudraLex Volume 4, Chapter 4 sets out how records are made, corrected and kept, on any medium. Annex 11 adds what a computerised system must do: access control, audit trails, backups and electronic signatures. ALCOA++, the shorthand used throughout, is set out in the July 2025 draft revision of Chapter 4 (draft clause 4.63). The Chapter 4 in force today, and Annex 11, ask for the same things in their own clauses. The July 2025 drafts of a revised Chapter 4 and Annex 11 are named where relevant, as drafts.
Basis
EudraLex Volume 4, Part I, Chapter 4 (Documentation), 2011, and Annex 11 (Computerised Systems), 2011; draft revised Chapter 4, 2025
If your records have to stand up to an inspector reading them years from now, this is the course to start with.
Enrolment gives access to all five lessons, the narrated topics, the workshop, the final assessment and the printable job aids. Work through it at your own pace; your progress is saved.
