1.0 OBJECTIVE :
- To lay down the procedure to record the specimen signature.
2.0 SCOPE :
- This procedure is applicable to for recording of specimen signature of all the staff up to level of department head.
3.0 RESPONSIBILITY :
- Concerned Department Head
4.0 ACCOUNTABILITY:
- Quality Assurance Head
5.0 PROCEDURE :
5.1 Specimen signature is a signature of an employee as proof of authenticity & identity of a person who is signing the documents.
5.2 Specimen signature shall provide documentary evidence for signing the particular documents and performing particular jobs.
5.3 Specimen signature shall provide a traceability of the documents signed by that particular personnel.
5.4 Specimen signature of each & every personnel, who is responsible for signing the documents, shall be maintained.
5.5 Quality Assurance Officer or his/ her designee/nominee shall maintain the record of the specimen signatures in the signature log.
5.6 The signature log shall be updated when new employee are recruited, within a month.
5.7 The specimen signatures shall be recorded as full signatures and short signatures against “SIGNATURE” and “INITIAL” columns respectively after completion of his/her induction training program.
5.8 Employee shall not change the specimen signatures during the tenure of the assignment.
5.9 When any employee Joins/Resigns detail is to be mentioned in the remarks column and records shall be updated accordingly on monthly basis.
5.10 Record shall be preserved for five years.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| Q.A. | Quality Assurance |
| GEN | General |
| QAD | Quality Assurance Department |
7.0 ANNEXURES:
| Annexure No. | Title |
| 01 | Format for Signature Specimen |
8.0 SOP REFERENCES
- GMP Guidelines
END OF THE SOP
ANNEXURES :
Annex. No. 01 Format for Signature Specimen
