Purpose

Record, correct, review and retain GMP data so that every entry, on paper or in a system, can be traced to a person, a time and an original observation that an inspector can trust.

Learning outcomes

Apply each ALCOA+ attribute to a paper record and an electronic record, and explain what breaks when one is missing
Make and correct entries the way EU GMP 4.7 to 4.9 and 4.20 require, without obscuring the original
Explain why shared logins, disabled audit trails and unlocked spreadsheets are cited as data integrity failures
Perform a risk-based audit trail review that finds what matters and documents what was reviewed
Follow a record from creation to archive and identify where hybrid systems lose control
Recognise the culture signals inspectors read, and describe a credible remediation plan

What the site gets back

Records an inspector can trust: entries made at the time, corrections that keep the original legible, and no unattributable results
An audit trail review that is actually performed and documented, closing the gap Annex 11 section 9 inspectors open first
A certificate with a verifiable ID for the training matrix, meeting the expectation that everyone who touches GMP records is trained in data integrity
Fewer data integrity observations, because shared logins, uncontrolled spreadsheets and end-of-shift entries are recognised and fixed before the inspection

Modules

1. What data integrity is and why inspectors lead with it
2. ALCOA+ on paper: recording, correcting, reviewing
3. Electronic records, audit trails and access control
4. Audit trail review and hybrid systems
5. Data lifecycle, retention and spreadsheets
6. Governance, culture and remediation

Regulatory mapping

EU GMP Ch. 4 (4.1 to 4.12; 4.20 onwards); EU GMP Annex 11 (s.7, 9, 12, 14); Annex 11 s.4 (Validation of computerised systems); PIC/S PI 041-1 (Data management and integrity); EMA DI Q&A (GMP/GDP Inspectors Working Group); ICH Q9 (R1) (Quality risk management, adopted in the EU); eIDAS (EU) 910/2014 (Electronic signatures, Art. 26); ISO 13485 (4.2.4, 4.2.5).

Cost comparison. A one-day classroom course on the same topic typically costs €800 to €1,500 per person plus travel and a day away from the site. This course is priced for the waitlist launch for ninety minutes in the learner's own time. Team licences with a manager view and completion exports are available from the academy.