Glossary

Say what the inspector means

The vocabulary of data integrity, grouped by stage of the data lifecycle. Definitions are ours; the source clause is given where one exists.

Principles

Data integrity: The degree to which data are complete, consistent, accurate, trustworthy and reliable throughout the data lifecycle. A property of the record and the process that produced it, not of the technology.PIC/S PI 041-1 s.5; EMA DI Q&A
ALCOA+: The attributes a record must have to be trusted: attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring and available. The regulators use it as a checklist; so should you.PIC/S PI 041-1 s.6.2; EMA DI Q&A
Attributable: It is possible to identify who performed the activity or made the entry, and when. On paper this is initials and date; in a system it is a unique user identity captured in the record and the audit trail.EU GMP 4.8, 4.20(c)
Legible: The record can be read, and will remain readable, for its whole retention period. Covers handwriting, ink, fading thermal paper and electronic formats that need software no longer available.EU GMP 4.1, 4.9
Contemporaneous: Recorded at the time the activity was performed. Not at the end of the shift, not from a scrap of paper, not from memory. Late entries are permitted only when marked as such.EU GMP 4.8, 4.20
Original record: The first capture of the data, in the medium in which it was first captured, or a verified true copy. For a chromatography system the original is the electronic data file with its metadata, not the printout.EU GMP 4.1; PIC/S PI 041-1 s.9.4
Accurate: The record reflects what actually happened and what was actually observed, without editing or selection. Accuracy is protected by calibration, validation, second-person checks and an unbroken audit trail.EU GMP 4.1; PIC/S PI 041-1 s.6.2
Good documentation practice (GDocP): The set of behaviours that produce ALCOA+ records on paper and in systems: how to make an entry, how to correct it, how to sign it, how to store it. The name is generic; the requirements are in Chapter 4.EU GMP Chapter 4; PIC/S PI 041-1 s.8

Records and entries

Metadata: Data about data: the who, when, what and why that gives a value its meaning. The time stamp, user identity, instrument, method version and processing parameters attached to a result. Without it the result cannot be reconstructed.PIC/S PI 041-1 s.8.7; EMA DI Q&A
Raw data: The original records and documentation retained in the format in which they were generated, or as a true copy. Raw data must permit full reconstruction of the activity.EU GMP 4.1; PIC/S PI 041-1 s.8
True copy: A copy of an original record that has been verified as complete, including metadata and the audit trail where relevant, and certified as such. A scanned page with a dated signature can be a true copy; a screenshot of a result usually is not.PIC/S PI 041-1 s.8.9; EMA DI Q&A
Single-line correction: The only acceptable way to correct a handwritten entry: one line through the original so it remains legible, the new entry beside it, initials, date and where necessary a reason.EU GMP 4.9
Late entry: An entry made after the activity it records. Permitted when unavoidable, provided it is identified as a late entry with both the date of the activity and the date of writing, and is not passed off as contemporaneous.EU GMP 4.8; PIC/S PI 041-1 s.8
Backdating: Recording a date or time other than the true one so that an entry appears contemporaneous or an activity appears to have happened when required. Falsification, regardless of intent.EU GMP 4.8, 4.9; PIC/S PI 041-1 s.8
Blank form control: Issue of numbered, controlled blank forms and logbook pages, with reconciliation of the copies issued, so that a page cannot be quietly replaced with a rewritten one.EU GMP 4.2 to 4.5; PIC/S PI 041-1 s.8.4

Systems

Audit trail: A secure, computer-generated, time-stamped record of the creation, modification and deletion of electronic records, showing who did what, when and why. It must not be editable by the user and must be retained with the record.Annex 11 s.9; PIC/S PI 041-1 s.9
Audit trail review: A documented, risk-based examination of audit trail entries by a person independent of the data generation, looking for changes to results, reprocessing, aborted runs, deletions and configuration changes before the data are used.Annex 11 s.9; PIC/S PI 041-1 s.9.5; EMA DI Q&A
Unique user identity: One login per person, never shared, so that every action in a system can be attributed. A shared or generic account makes every entry under it unattributable and is one of the most cited data integrity failures.Annex 11 s.12.1, 12.3; PIC/S PI 041-1 s.9
Access control: Physical and logical restrictions so that only authorised people can use a system, and each person can do only what their role requires. Users who generate data should not hold administrator rights over that data.Annex 11 s.12; PIC/S PI 041-1 s.9.3
Electronic signature: A legally binding equivalent of a handwritten signature applied in a system. It must show the signer's printed name, the date and time, and the meaning of the signature, and be permanently linked to the record.Annex 11 s.14; eIDAS Regulation (EU) 910/2014 Art. 26
Hybrid system: A process where the record is partly electronic and partly paper, typically an instrument producing electronic data with a signed printout used as the reviewed record. Both parts are GMP records and both must be controlled and retained.PIC/S PI 041-1 s.9.4; EMA DI Q&A
Computerised system validation: Documented evidence that a system does what it is intended to do, consistently, including the controls that protect data integrity. Applies to spreadsheets used for GMP calculations as much as to a LIMS.Annex 11 s.4; Annex 15
Uncontrolled spreadsheet: A workbook used to calculate or report GMP results without validation, version control, locked formula cells or access restriction. Inspectors treat it as an unvalidated computerised system.Annex 11 s.4, 6, 12; PIC/S PI 041-1 s.9

Lifecycle

Data lifecycle: Every stage of a record's existence: creation, processing, review, reporting, retention, retrieval and destruction. Controls are needed at each stage; most failures are found where data move between stages or systems.PIC/S PI 041-1 s.5.3; EMA DI Q&A
Retention period: How long a record must be kept. Batch documentation for at least one year after expiry or five years after QP certification, whichever is longer; other GMP records according to the activity they support.EU GMP 4.11, 4.12; Annex 19
Archive: The controlled, long-term storage of records, including electronic records with their metadata and audit trail, in a form that stays readable and retrievable for the whole retention period. Not the same as a backup.Annex 11 s.17; EU GMP 4.10
Backup: A copy of current data kept so that it can be restored after loss or corruption. A backup protects availability; it does not satisfy archive requirements and must itself be tested by restoration.Annex 11 s.7.2
Enduring: The ALCOA+ attribute that the record survives intact for its retention period: no fading ink, no thermal paper without a copy, no proprietary file format that cannot be opened in ten years.EU GMP 4.1, 4.10; Annex 11 s.17
Available: The record can be retrieved for review, audit or inspection within a reasonable time throughout its retention period. Data on a decommissioned server that nobody can access are not available.EU GMP 4.10; Annex 11 s.17

Findings and governance

Testing into compliance: Repeating, aborting or reprocessing an analysis until a passing result is obtained, and reporting only that result. Includes trial injections, renamed samples and selective integration. Treated as falsification.EU GMP 4.1, 6.16, 6.17; PIC/S PI 041-1 s.9
Trial injection: An unofficial injection of a sample to see the result before the official run. Any sample injection is a GMP record; hiding it as a system suitability or test run is a classic finding.EU GMP 6.16, 6.17; PIC/S PI 041-1 s.9
Data governance: The arrangements by which a company ensures data are recorded, processed, retained and used in a way that provides a complete, consistent and accurate record throughout the lifecycle. It is a management responsibility and includes culture, not just procedures.PIC/S PI 041-1 s.6; EU GMP 1.5, 1.6
Data criticality and risk: The basis for deciding how much control a record needs: how the data influence decisions about product quality and patient safety, and how vulnerable they are to alteration or loss. The reason a batch record and a canteen rota are not treated the same.PIC/S PI 041-1 s.5.4; ICH Q9 (R1)
Quality culture: The shared behaviours and pressures that determine whether people record what happened or what was expected. Inspectors assess it through interviews, open reporting and whether management targets can be met honestly.PIC/S PI 041-1 s.6.5; EU GMP 1.5
Remediation: The programme a site runs after a data integrity failure: scope the affected data, assess the impact on released product, correct the systems and behaviours, and demonstrate effectiveness. Regulators expect a third-party assessment for serious cases.PIC/S PI 041-1 s.11, 12; EMA DI Q&A