6. Failure to designate an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of Part 820 as required by 21 CFR 820.40(a). For example:
a) There is no requirement for documenting the signature of the individual approving the document.
In your firm’s letter of April 6, 2000, they state that by April 28th they will have a system for attaching electronic signatures to all relevant electronic documents. The software for this system will have been validated by that date.
They state that because they have more than three hundred documents in their quality system it will take them some time to complete the process of having signatures and records of changes on all their documents. They state that by June 30th they will have changed all the documents that cover the quality, design, production planning, purchasing, and stores functions and that by July 31st all documents will have been reviewed, and all relevant documents will have an electronic signature and records of changes.
This response is not adequate because your firm has not submitted documentation of the changes or copies of the procedures.
b) Electronic documents are not electronically signed and there is no signed hard copy record.
Your firm’s response is indicated in 6a above. This response is not adequate because your firm has not submitted documentation of the changes or copies of the procedures.
c) The electronic record system lacks computer generated time stamped audit trails. Your firm’s response is indicated in 6a above. This response is not adequate because your firm has not submitted documentation of the changes or copies of the procedures.
7. Failure to control records as required by 21 CFR 820.40(b). For example: Change records do not include a clear description of the change, reason for the change, a full description of the change, the identification of the affected documents and the signature of the individual approving the changes. Change records consist of a hidden text (footnote) on the electronic record identifying the change. The date of the change is the date the revised procedure was released and saved in the approved procedure file.
Your firm’s response is indicated in 6a above. This response is not adequate because your firm has not submitted documentation of the changes or copies of the procedures. …
9. Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example: Software such as Excel, Access, and Word used to create and maintain data bases (rejects, complaints, and concessions) and electronic documents, is not validated.
In their response dated April 3, 2000, your firm stated that by May 31st,they will have identified what software is used for data processing, and identified a method or methods for validation and/or verification of the software. Furthermore, they state, they will complete a full and thorough validation of all software that is used for the handling of information or data used in the quality system. This response is not adequate since your firm has not submitted the required validation information.
SoftwareCPR Keywords: Part 11 Electronic Record Electronic Signatures
