Documentation and Data Integrity Essentials

What the course teaches and assesses

• Tell an instruction from a record, find where a value was first captured, and use ALCOA++ as ten questions you can ask of any record
• Record at the time, under your own name and login, on a controlled form, with no empty fields
• Correct paper and electronic records so the original can still be read, and recognise when a correction has become a change to the result
• Check 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 access matched to the job, keep records restorable and readable for their retention period, and raise a data integrity problem openly

Lessons

1. 1What a GMP record is: the original record, raw data and ALCOA++
2. 2Making the entry: at the time, under your own name, on a controlled form
3. 3Correcting it: paper corrections, electronic changes and reasons for change
4. 4Reviewing it: second-person checks, audit trail review, the data not the printout
5. 5Keeping it: access, retention, backup and archive, and what to do when something goes wrong
6. Scored final exam and dated certificate

Who it is for

• Anyone who makes, checks, reviews or approves a GMP record
• Production, QC laboratory, engineering and warehouse
• Quality assurance

Regulations referenced

• EU GMP Chapter 4 (Documentation)
• EU GMP Annex 11 (Computerised Systems)
• Draft revision of EU GMP Chapter 4 (2025), not yet in force