Terminology Done by/Performed By, Prepared By, Checked By / Witnessed By, Verified By, Reviewed By, Approved By / Authorized By

Terminology Done by/Performed By, Prepared By, Checked By / Witnessed By, Verified By, Reviewed By, Approved By / Authorized By

Explaining below terminology which are commonly used in the pharmaceuticals and difference between Done by/Performed By, Prepared By, Checked By / Witnessed By, Verified By, Reviewed By, Approved By / Authorized By. 

 

Terminology Done by/Performed By, Prepared By, Checked By / Witnessed By, 

Verified By, Reviewed By, Approved By / Authorized By

1.      Done By / Performed By (Doer/Performer):

The person who executed/performed the work and documented it. In other words, the doer/performer is a person who is responsible for the activity, the signature is attributable to the person performing the activity (work) or generating the data.

2.     Prepared By : (Author/ Creator)

The person who has created/ prepared the documents and also applicable in case of preparation of any solution. This terminology is generally (mostly) referred for document creation. The author/creator(data recorder, preparer, owner, etc.) provides the signature of the person writing the document, information, data, record, report, and preparation of any solution, working standards etc.

3.     Checked By / Witnessed By:

 The person is responsible for observing the actual procedure or witness of the performance of the task or performing an independent check to ensure that the task was performed correctly. The checked by check that the Doer has recorded Contemporaneously (an online record). In case of documentation checked by check the author documentation for the correctness/ accuracy.

4.    Verified By:

The person is responsible for verifying the activity/work based on the raw data/ details which are evidence of that performed activity/work. The ‘Verified By’ signature shows the person who ensured that the work was performed and documented correctly. Verifier verifies that sequential steps were performed and the doer/performer has recorded the entries, based on objective evidence, associated records/ logs, documents etc.

 5.     Reviewed By :

 The person responsible for reviewing (follow the ALCOA+) the document or record to confirm its accuracy, completeness, contemporaneous (online work), clarity and legibility, including checking the calculations as applicable. Reviewer is responsible for reviewing the documents based on the evaluation of the supporting data, documents and/ or references attached. 

 6.    Approved By/ Authorized By:

 The person responsible for verification of the data to ensure it was done accurately, completely, and in compliance with the procedural requirement on that basis, person approve/authorize the documents.

 HOD/authorized a designee who has the right to approve documents. Quality related documents are only approved by Quality Head/Authorized Designee.

 Authorized by signatory is mostly Plant Head / HOD / Director/ person who has the right to authorize the documents.

 Below is the sequence/flow of person verification:

  As per the requirement of documents signatory person evaluate.

 Done By / Performed By or Prepared By    Checked By / Witnessed By   Verified By    Reviewed By   Approved By    Authorized By

 

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