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 recording of specimen signature of all the personnel working at Pharmaceutical Company.

• Responsibility
  • Concerned personnel of all department 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 implementation of this SOP.

• Abbreviations and Definitions
• SOP : Standard Operating Procedure

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• Procedure
  • Specimen signature is a signature of an employee of proof 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 a traceability of the documents signed by that particular personnel.
  • 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 “SIGNATURE” and “INITIAL” columns respectively.
  • For any person who practices single signature, the same signature shall be recorded in both the columns.
  • The concern department / section – head shall check the initial / full signature of his department personnel and same shall be submitted to QA department.
  • Employee shall not change the specimen signatures during the signing of the documents.
  • When any employee join/resigns/transfer to other location. Detail shall be mention 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

Date	Revision Number	Reason for Revision
–	–	New SOP

 

Annexure-I

Signature Log

Department/ Section: _____________________________________

 

Sr. No.	Name	Designation	Signature	Initial	Remarks

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