QMSCAPA and FDA Title 21, Sub-Chapter A, Part 11

Subpart B--Electronic Records

Limiting System Access (21 CFR, Section 11.10(d))

Limiting System Access may be controlled by the QMSCAPA standard Security Module

Program Time-Outs (21 CFR, Section 11.10(d))

QMSCAPA requires Windows Vista or higher; program time-outs may be controlled by the OS.

Authority Checks (21 CFR, Section 11.10(g))

Authority Checks may be controlled through the QMSCAPA standard Security Module.

QMSCAPA (v1.33) provides support for ...

(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).

Signature/record linking (21 CFR, Sec. 11.70)

QMSCAPA provides a method for electronic signatures and handwritten signatures executed to electronic records so they may be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.