This is a ready-to-use form for classifying each GxP record type in a system as static or dynamic and pinning down what the true original is, so your retention, review, and true-copy rules follow from a documented decision rather than a habit. It is the record that answers an inspector’s question “for this data, what is the original and are you keeping it in the right form?” Replace every <<FILL: ...>> placeholder, keep one row per record type, and maintain the form under document control. A field-definition table, the blank form, instructions, and a filled specimen follow. Verify each cited source against the current version. This is general guidance to adapt, not legal or regulatory advice.
Why this form exists
Whether a record must be kept in dynamic form, reviewed with its audit trail, and copied through a validated export rather than a printout all depend on one prior decision: is the original static or dynamic, and what is the original. Making that decision explicitly, per record type, is what keeps a program from quietly treating a manipulable data file as if a PDF of it were the record. It also gives the true-copy and retention procedures a defined input instead of a case-by-case guess.
Field definitions
| Field | Format | Required | Who enters | Definition |
|---|---|---|---|---|
| System / process | Text | Yes | Record owner | The system or process that generates the record type. |
| Record type | Text | Yes | Record owner | The specific record (for example, HPLC chromatogram, balance printout, batch record page). |
| Original (raw/source) | Text | Yes | Record owner / SME | What the true original is and the format it is first captured in. |
| Static or dynamic | Static / Dynamic | Yes | SME | Whether the original is fixed-format (static) or interactive/reprocessable (dynamic). |
| Basis for classification | Text | Yes | SME | Why: can it be searched, reprocessed, re-integrated, re-queried? |
| Retained in form | Dynamic / Static / Both | Yes | SME + QA | The form in which the original must be retained for its retention period. |
| Audit trail review required | Yes / No | Yes | QA | Whether audit trail review applies (yes for dynamic decision-relevant data). |
| True-copy method | Text | Yes | Validation / QA | How a true copy is made (validated export/migration for dynamic; verified scan for static). |
| Retention period | Text | Yes | QA | The retention period per the retention schedule. |
| Assessed by / date | Name, date | Yes | Assessor | Who classified it and when. |
| QA approval / date | Name, date | Yes | QA | QA review and approval. |
Blank form
| System / process | Record type | Original (raw/source) | Static or dynamic | Basis | Retained in form | Audit trail review | True-copy method | Retention | Assessed by / date | QA / date |
|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Static / Dynamic>> | <<FILL>> | <<FILL>> | <<FILL: Yes / No>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Instructions
- Complete one row for every distinct GxP record type the system produces, not one row per system. A CDS produces at least a dynamic data file and a static printed report; both get rows.
- Decide static vs dynamic on the original, not on the copy you happen to store. If the source can be reprocessed, it is dynamic even if you usually look at a printout.
- For a dynamic original, “retained in form” is Dynamic (or Both), audit trail review is Yes, and the true-copy method is a validated export or migration, never a PDF.
- Route the completed form through QA approval, and re-assess a row on any change to the system, formulation, instrument, or configuration that could change what the original is.
- Feed the true-copy method column into the SOP: True Copy Generation, Verification, and Certification.
Retention
Retain the classification form under document control for the life of the system plus <<FILL: retention period>>, and treat it as a controlled input to the retention schedule, the audit trail review SOP, and the true-copy SOP.
Filled specimen
| System / process | Record type | Original (raw/source) | Static or dynamic | Basis | Retained in form | Audit trail review | True-copy method | Retention | Assessed by / date | QA / date |
|---|---|---|---|---|---|---|---|---|---|---|
| CDS, HPLC-07 | Chromatogram data file | Acquired CDS data file + audit trail | Dynamic | Can be re-integrated, re-baselined, recalculated | Dynamic | Yes | Validated archival export ARC-EXP v3.2 | 10 years post-batch | A. Patel, 18 Jul 2026 | M. Okafor, 19 Jul 2026 |
| CDS, HPLC-07 | Printed result report | PDF/paper report of the result | Static | Fixed view, no interaction | Static (summary only) | No | Verified scan or controlled PDF | With batch record | A. Patel, 18 Jul 2026 | M. Okafor, 19 Jul 2026 |
| Analytical balance BL-12 | Weight printout | Balance printout or interfaced electronic value | Static | Single fixed reading, no reprocessing | Static | No (verify transcription instead) | Verified scan; prefer validated interface | 10 years | A. Patel, 18 Jul 2026 | M. Okafor, 19 Jul 2026 |
| Stability chamber SC-3 | Temperature datalogger file | Datalogger electronic file | Dynamic | Query and re-plot; carries excursion/alarm history | Dynamic | Yes | Validated export with metadata | Study + 1 year | A. Patel, 18 Jul 2026 | M. Okafor, 19 Jul 2026 |
The specimen shows the useful pattern: the same instrument (HPLC-07) produces one dynamic record and one static record, each classified separately, with different retention forms, audit trail rules, and copy methods flowing from the classification.
Common inspection findings this form prevents
- A dynamic record type is treated as static, so only printouts are retained and the audit trail is never reviewed.
- No documented decision exists for what the original is, so different reviewers make different calls.
- A “true copy” method is applied that flattens a dynamic record because the record was never classified as dynamic.
- A system change altered what the original is, and the classification was never revisited.
How to adapt this form
- Pre-populate the System / process column from your computerized system inventory.
- Align the retention column to your retention schedule so the two never disagree.
- Point the true-copy method column at your validated export/migration tools by name.
- Add a review-due field if you re-assess classifications on a periodic cycle.
- Confirm the static/dynamic definitions against the current MHRA and FDA data integrity guidance before issue.