Sop on Recording of Specimen Signature
To lay down the procedure to record the specimen signature.
This Standard Operating Procedure is applicable for the recording of specimen signatures of all the personnel working at Pharmaceutical Company (Name).
- Concerned personnel of all departments shall be responsible for following the procedure written in the SOP.
- QA officer (Documentation Cell) or his/her designee shall be responsible for maintaining the record of specimen signature.
Accountability: QA Head shall be accountable for the implementation of this SOP.
Abbreviations and Definitions
- SOP : Standard Operating Procedure
- QA :Quality Assurance
- Specimen signature is a signature of an employee of proof of authenticity & identity of a person who is signing the documents.
- Specimen signature shall provide documentary evidence for signing the particular documents and performing particular jobs.
- Specimen signature shall provide traceability of the documents signed by that particular person.
- Specimen signature of each & every personnel, who is responsible for signing the documents, shall be maintained.
- QA officer (Documentation Cell) or his/ her designee/nominee shall maintain the record of the specimen signatures in the Signature Log (As per Annexure –I).
- The Signature Log shall be updated when new employees are hired.
- The specimen signatures shall be recorded as full signatures and short signatures against the “SIGNATURE” and “INITIAL” columns respectively.
- For any person who practices a single signature, the same signature shall be recorded in both columns.
- The concerned department/section – head shall check the initial/full signature of his department personnel and the same shall be submitted to the QA department.
- Employees shall not change the specimen signatures during the signing of the documents.
- When any employee joins/resigns/transfers to another location. Detail shall be mentioned in the remark column and records shall be updated accordingly.
- As a matter of policy “Signature Log” is reviewed every year.
Forms and Records (Annexures)
- Signature Log – Annexure-I
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering & Human Resource
Department/ Section: _____________________________________
- Sr. No.