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1. Paper entries

Every entry is made at the time of the activity, not batched at the end of the shift (EU GMP 4.8)
Every entry carries the initials or signature of the person who did the work and the date (EU GMP 4.8, 4.20(c))
Entries are in indelible ink; no pencil, no erasable pen, no correction fluid
No blank fields: unused fields are struck through or marked N/A with initials and date
Times are recorded from a controlled clock and match the equipment logs for the same activity

2. Corrections

Original entry remains legible under a single-line strike-through (EU GMP 4.9)
Correction is initialled and dated by the person who made it
Reason for the correction is recorded where it is not obvious
Late entries are marked as such with the actual date of entry and the date of the activity
No pages torn out, no overwriting, no obliteration anywhere in the record

Every user of every GMP system has a unique login; no shared, generic or group accounts (Annex 11 s.12.1, 12.3; PIC/S PI 041-1 s.9)
Roles are defined so that the person generating data cannot also delete it or alter the audit trail configuration
Administrator rights are held by named IT or system owners, not by the users who produce results
A current user list per system exists and has been reviewed against leavers and role changes (Annex 11 s.12.3)
Password rules and session timeouts are enforced by the system, not by policy alone

Audit trail is enabled and cannot be switched off by a routine user (Annex 11 s.9; PIC/S PI 041-1 s.9)
Audit trail captures who, what, when and, for changes to GMP data, why
Audit trail settings are locked and any change to them is itself recorded
Audit trail review is defined in a procedure with frequency, scope and what to look for
Audit trail review is documented and covers the events that could change a result: reprocessing, aborted runs, manual integration, deleted data

Electronic signatures show the signer's name, the date and time, and the meaning of the signature (Annex 11 s.14(c))
Signatures are permanently linked to their records so they cannot be copied or moved (Annex 11 s.14(b); eIDAS (EU) 910/2014 Art. 26(d))
Signature components (user ID and password) are under the signer's sole control, never shared, and re-entered as required (Annex 11 s.12.1; eIDAS Art. 26(c))
A procedure states that electronic signatures have the same impact as handwritten signatures within the company, and each signer has acknowledged it (Annex 11 s.14(a))

Each system is classified as electronic, paper or hybrid, and the original record for each is named
Where a printout is signed as the record, it includes all data and metadata needed to reconstruct the result (PIC/S PI 041-1 s.9.4)
The electronic file remains retained and reviewable; the printout does not replace it
Hybrid arrangements have a documented rationale and a plan to remove them

Every spreadsheet used to generate or report GMP data is listed in an inventory
Formula cells are locked and the template is version controlled
Each template was validated against known inputs before use (Annex 11 s.4)
Calculated results are independently verified or the spreadsheet is qualified as the verification

Retention period per record type is defined and at least one year past expiry or five years past certification, whichever is longer (EU GMP 4.11, 4.12)
Archived electronic records remain readable, including metadata and audit trail, for the whole retention period (Annex 11 s.17)
Backup is distinguished from archive and restoration has been tested
Original records are kept where they were generated or under a documented transfer

A data integrity policy exists, is owned by senior management and names the site's data integrity lead (PIC/S PI 041-1 s.6)
A data risk assessment covers each system and process, and the controls are proportionate to the risk
Data integrity failures are reported and investigated through the deviation system, not handled informally
Periodic review of systems includes audit trail configuration, user lists and the spreadsheet inventory (Annex 11 s.11)

Everyone who makes GMP entries has documented good documentation practice training, including contractors
Staff can explain why the rules exist, not just what they are
There is a route to report pressure to falsify or backdate, and it has been used without penalty
Managers do not set targets that can only be met by altering or omitting data