Sop on Recording of Specimen Signature

Sop on Recording of Specimen Signature

Objective :

To lay down the procedure to record the specimen signature.

Scope:

This Standard Operating Procedure is applicable for the recording of specimen signatures of all the personnel working at Pharmaceutical Company (Name).

Responsibility

• 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

Procedure

• • 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

Distribution

• Master copy – Quality Assurance
• Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering & Human Resource

History                                       

Annexure-I

Signature Log

Department/ Section: _____________________________________

• Sr. No.
• Name
• Designation
• Signature
• Initial
• Remarks

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