Date: August 9, 2001

1350 Piccard Drive, Rockville, MD 20850

Representing Prelude Computer Solutions, Inc. Parsippany, NJ 07054:

Representing the Food and Drug Administration:

The meeting was held at the request of Prelude Computer Solutions, to discuss the firm’s suite of electronic records software in the context of 21 Code of Federal Regulations, Part 11; Electronic Records, Electronic Signatures. At the start of the meeting we explained that FDA does not approve or disapprove of products and services that enable regulated firms to comply with FDA requirements and that our comments should be considered in that light.

The firm’s representatives explained that the firm is a systems integrator that provides a software suite, DocuKnowledge, built upon standard applications. The software functionality is engineered for electronic submissions, with Part 11 requirements in mind. At the core of these applications is the Lotus/IBM Domino.doc application. The firm can provide add on software to companies that already have this application, or can provide a pre-defined package. The system produces PDF file formats, and a scalable, secure, web based document management system.

The firm’s presentation outlined how various part 11 requirements were implemented by the DocuKnowledge suite.

During the meeting we discussed the firm’s validation activities. The firm provides its customers with test scripts and system design specifications. The firm is also amenable to audits of its software development activities.

The representatives gave us a brief product demonstration, showing how the web based system authenticates users, implements audit trails, displays electronic record meta data and integrates with web browser and word processing software.

During the course of the meeting we commented that PDF file formats that did not permit the processing of record information would be problematic. We noted that for records containing only text, there should be no problem with a PDF file that permitted word searches; however, we remarked that information in the files that could not be processed, such as images of spreadsheets and tables would be problematic from a part 11 perspective. Part 11 requires that persons be able to generate electronic copies of electronic records that are suitable for FDA review.

Regarding audit trails, we commented that the system was inappropriately allowing end users to write comments to the audit trail at will. We suggested moving comments to a different file because end users should not be able to write to an audit trail at will. We expressed the same suggestion and comment regarding the audit trail entry field called "initial draft." We also noted that electronic record deletions were apparently documented in a file separate from what is called the audit trail, making it appear that the audit trail did not capture deletions.

Regarding the system’s implementation of electronic signatures, we commented that the profile display did not indicate what the signature means. Part 11 requires that the meaning of the signature be part of the human readable display of a signed electronic record. We also commented that from the record approval feature, it was not clear exactly what record the approver was signing.

We discussed archiving. The firm preserves files in the native electronic format and is considering augmenting that with XML formats.

Concerning password controls, the system implements configurable password aging, length, and composition.

The meeting lasted about two hours.

Subsequent to the meeting, the firm provided the attached PDF files, an explanation of electronic signature manifestations, and slides from the firm’s demonstration/presentation that could be posted to the public docket.

cc:

FDA meeting attendees

HFA-224

Part 11 Guidance Dockets

doc id: MemoOfMeetingPrelude080901.doc

P. Motise

9/4/01