Documentation, Records, and Data Integrity
This domain tests the record hierarchy, what a batch and laboratory record must contain, how corrections are made, how long records are kept, and how data integrity is protected in electronic and paper systems. Data integrity questions are common and are usually about behaviour, not technology.
Document hierarchy and required records
- The hierarchy runs from policy to standard operating procedure to work instruction to master and executed batch records and analytical records.
- 211.186 requires the master production record to include name, strength and dosage form, identity of the active ingredient, weight or measure of each ingredient per dosage unit and per batch, and a statement of theoretical yield. 211.188 sets out the executed batch record content.
- 211.192 requires the quality unit to review production and laboratory records before release, covering yield, discrepancies and failures.
- 211.194 specifies laboratory record content, including sample description, method, weights, calculations, results and the initials and dates of the analyst and reviewer.
Data integrity: ALCOA+
- Records must be attributable, legible, contemporaneous, original and accurate, and also complete, consistent, enduring and available.
- Corrections use a single line strike-through so the original entry remains legible, with initials, date and the reason for the change. No correction fluid, no overwriting, no backdating.
- Raw data is the first record of an activity, including chromatograms, spectra and metadata. A printout is not the raw data where the system holds dynamic electronic records.
- Audit trails must be secure, computer-generated and time-stamped, must not be switchable off by users, and must be reviewed as part of record review.
- Access requires unique user identification, role-based permissions, no shared logins, and periodic review of who holds access.
- Retention under 211.180 is at least one year after the expiry date, or three years after distribution for products without expiry dating. EU GMP Chapter 4 requires batch records to be kept one year after expiry or five years after certification, whichever is longer.
Worked example
An analyst transposes a weight in a laboratory notebook and notices three days later. The correct action is to strike a single line through the wrong figure, write the correct value beside it, initial and date the correction with today's date, and state the reason, for example correction of transcription error verified against the balance printout. The printout is attached or referenced. Rewriting the page, reprinting the record, or dating the correction as if it were made on the original day are all integrity failures.
Traps that cost marks
- Backdating, or writing the original date on a correction made later.
- Disabling audit trails or sharing logins for convenience.
- Keeping only a PDF printout when the system holds dynamic data with metadata.
- Treating 21 CFR Part 11 as covering electronic signatures only; it covers electronic records too.
- Reviewing a batch record without checking the accompanying audit trail and raw data.