This is a ready-to-use log of who is currently authorized to sign or approve which class of GxP quality decision. It is the single place an investigator, or a colleague checking a signature they do not recognize, can go to confirm that a given name was authorized, for what, and on what date. Replace every <<FILL: ...>> placeholder with your specifics and route it through your document control. A filled specimen follows. This is general guidance to adapt, not legal or regulatory advice.
Authority scope legend
Define the codes used in the log so a reviewer does not have to guess what each authorization covers. Adapt to your quality system.
Signature authority log
Field definitions
Rules
- No one signs or approves a decision outside their authorized scope, product limit, or active date range on this log.
- A scope change (wider, narrower, or a new product added) is a new dated line, not an edit over the old one, so the history of what someone was authorized to do on a given date is never lost.
- The end date is entered the same week authority ends, whether from role change, departure, or extended leave, never retroactively discovered.
- Every authorization carries a named backup before it is needed, not sourced informally when the incumbent is already unavailable.
- QA co-signs every entry, because signature authority is a quality-system control, not a management delegation alone.
Filled specimen
Illustrative, values invented. Oral solid dosage site.
The fourth row shows the log doing its job: P. Singh’s validation approval authority was closed on 2026-09-10, so any validation report bearing that signature after that date is a finding, not a valid approval, and the reviewer checking it does not need to ask anyone; the log answers it directly.
Common inspection findings this log prevents
- A batch, deviation, or protocol signed by someone whose authority was never documented, discovered only when the signature is challenged.
- A signature from someone who left the role or the company, with no end date recorded, so the gap is found by accident rather than by control.
- Authority granted verbally or by implication from a job title, with no scope, product limit, or QA co-sign on record.
- No backup named for a sole authorized signer, turning a planned absence into an undocumented single point of failure.
How to adapt this log
- Set your authority scope codes to match the decisions your quality system actually delegates; do not reuse the starter list without checking it against your own SOPs.
- Add a product or system limit column granularity that matches your operation; a multi-product site needs it, a single-product site may not.
- Decide your review cadence (commonly quarterly for an active roster, plus event-driven updates) and state it in the header.
- Pair this log with the GxP role qualification and job description form so authority, training, and qualification are all traceable from the same name.
