Explaining below terminology which is 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.
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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 person is responsible to, check that the doer has recorded Contemporaneously (an online record). In case of documentation checked by person is responsible to, check the author documentation for 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 approves/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 evaluation done:
FAQ:
1. What do you mean by ‘checked by’?
The person is responsible for observing the actual procedure or witnessing the performance of the task or performing an independent check to ensure that the task was performed correctly. The checked by the person is responsible to, check that the doer has recorded Contemporaneously (an online record). In case of documentation checked by a person who is responsible, check the author documentation for correctness/ accuracy.
2. What does it mean when something is approved?
Something is approved it means the verification of the data to ensure it was done accurately, completely, and in compliance with the procedural requirement on that basis, person approves the objects, item, documents, etc. In simple words on the basis of judgment, agreed or satisfied with the object.
3. What is the difference between checked by and verified by?
Checked by or Witness 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 a person is responsible to, check that the doer has recorded immediately.
Verified by:
The person is responsible for verifying the activity based on the original data (raw data)/details which are evidence of that performed activity. The ‘Verified By’ signature shows the person who ensured that the work was performed and documented correctly.
4. Does verified mean approved?
No. Verified and approved are different terms. Verified means the verification, examination of the data or object. Approved means on the basis of judgment, agreed or satisfied with data or object.
Nice and perfect information in simple and understandable language…