1.0
OBJECTIVE:
To lay down the procedure for maintaining Specimen
Signatures of employees working in
2.0
SCOPE:
The SOP is applicable to all employees of who are involved
in signing during preparation, review, approval & authorization of
documents.
3.0
RESPONSIBILITY:
3.1
Quality
Assurance Officer /Executive to take the signature of the new employees as per SOP
3.2
Concerned
department HOD to inform about the new employee to QA department
3.3
Employees to
provide his/her specimen signature in Specimen Signature record as per Format No.: F/QA-005-01 in QA
department.
4.0
ACCOUNTABILITY:
Quality Assurance Head to implement this SOP in Plant Name, Address.
5.0
PROCEDURE:
5.1
Specimen
Signature is a Signature of an employee to proof authenticity of a person who
is signing the documents. Specimen Signatures shall provide documentary
evidence for signing the particular documents and performing particular jobs.
5.2
Specimen
Signature shall provide a traceability of the documents signed by that
particular employee.
5.3
Specimen
Signature of each & every employee, who is responsible for signing the
documents, shall be maintained in Format number F/QA-005-01 named Specimen
Signature Record.
5.4
The format
contains Department, employee’s name, Designation, Date of joining, initial
signature, and full signature and Remark column for Quality assurance personnel
for Quality assurance personnel for maintaining the status of the employee.
5.5
When any
employee resigns or transfers to other location, Specimen Signatures record
shall be updated in the remark column by writing Resigned or transferred.
5.6
Employee
shall not change the specimen signature during the signing the documents, if
any employee wants to change his/her specimen signature he/she shall change it
through change control with proper justification.
5.7
For any new
employee the employee has to maintain the specimen record in the same format as
per Format No. F/QA-005-01 in Quality assurance department.
5.8
Acceptance criteria
5.12.1 Specimen
Signature of all employees should be documented as authenticity proof.
5.12.2 Frequency: Whenever required or according to the above mentioned criteria.
6.0
LIST OF ANNEXURE AND FORMATS:
Sr. No. |
Title of
Format |
Format No. |
|
Specimen
Signature Record |
F/QA-005-01 |
7.0
REFERENCE:
7.1
SOP-QA- 001
7.2
F/QA-001-01
7.3
SOP-QA- 014
8.0
REVISION HISTORY:
Sr. No. |
Date |
Reason for Revision |
Revision No |
1.
|
31/10/2018 |
New SOP |
R0 |
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
Sr. No |
Abbreviations |
Details |
01 |
QA |
Quality Assurance |
02 |
SOP |
Standard operating
procedure |
END OF DOCUMENT
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Pharmaceutical guideline only