Avec COETIC, optimisez votre conformité réglementaire

Audit, Formation et Accompagnement de vos projets réglementés

jeudi 28 novembre 2019

Signatures–What’s in a Name?

It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
Nov 02, 2019

Volume 43, Issue 11, pg 59
Q. In a recent audit, we were asked about the meaning of the signatures on our controlled documents. Our reply was that it clearly states that the signatories are either authors, reviewers, or approvers. The auditor considered our response insufficient, pointing out that we often have up to 10 reviewers. Though the names and titles of these are given, their review responsibilities are not defined or described. We are unclear how to make the meaning of the signatures more precise.
A. The regulations do not provide much detail with regards to your question. For example, the European Union guidelines (1) require, “Documents containing instructions should be approved, signed, and dated by appropriate and authorised persons.” The US regulations are a little bit more specific in 21 Code of Federal Regulations (CFR) Part 11 (2) regarding the signing of electronic records and state, “This information must include the printed name of the signer, the date and time when the signature was executed, and the meaning [emphasis added] (such as review, approval, responsibility, and authorship) associated with the signature.”
Plus d'information ici