Part 11 and "Disappearing" Signature Manifestations

An interesting question appeared on-line today which we thought deserved airing with a wider audience via the blog.

Q. When implementing an electronic document management system, is it acceptable to make the author/approver names and dates disappear? Is this still in compliance with 21 CFR Part 11.50, Signature Manifestations?

A. Let's remind ourselves of the relevant rule:

§ 11.50 Signature manifestations.
(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).

The first question to ask ourselves is the question of scope. Not all of the documents stored in the EDMS will fall within the scope of 21 CFR Part 11. In fact, this is a notoriously difficult area in which to interpret the predicate rules. Some rules will clearly state that documents need to be signed and in other areas it must be inferred from the use of words like "authorised" or "approved".

The first thing to therefore do is to clearly decide which categories of document fall within the scope of 21 CFR Part 11 OR (to be on the safe side) to decide that the approval of all documents will meet the technical requirements of part 11.

Looking at the specific question of signature manifestations, subpart 11.50 (b) clearly states that the name of the person signing, the signature date and the meaning of the signature must be included in any printout or electronic display.

Making the names and dates "disappear" in some way clearly contravenes the requirements of 11.50 (b) if these components are not readable in either the on-screen display or the hardcopy printout of the document. If this were to be implemented we would consider the solution to be non-compliant with Part 11, at least with respect to the documents that fall within the scope of Part 11.