Focus On Team, Scope When Developing a Compliance Plan

Selecting the right members for your computer system validation (CSV) and 21 CFR Part 11 compliance teams will have a lot to do with whether your efforts are successful, an industry expert said.

Be certain to include the system owner, IT personnel, and a compliance/quality assurance representative, said Sonja Justice, senior consultant with Taratec Development. But don't lean too heavily on one type of professional, she advised. Instead, put together a team "with a great mix of skills," including subject matter experts and novices. You will gain from the depth of knowledge from the experts and get a fresh perspective from the novice members, she said.

After gathering the team, you will then need to assess system requirements by pulling together both user and technical requirements. But beware of too many "wants" or "nice to haves" coming from different disciplines within the company, Justice warned. Sometimes this happens by asking "the wrong people to develop requirements" within the company and being pressed to make quick decisions. Instead, the team should forge effective relationships with representatives from different disciplines, and get from them a comprehensive and realistic list of requirements, she advised.

Testing is critical, Justice said. Focus efforts on technical tests, such as determining if the system can handle the full user base, network traffic and expected number of concurrent users. Be certain to also test to determine if metadata are being converted properly, she said.

But beware of tests that provide a false sense of security. "Within a test environment everything is perfect because of limited users," she said. In addition, some tests give far too much time.

Be sure to secure the early involvement of selected teams to reflect real activity within your computer system. Be proactive in seeking out internal expertise because it can help you correct problems prior to system rollout, she said.

User Acceptance Tests (UATs) are also critical. They should examine whether:

The right document is being imported; Scanned images are complete; and Special characters are being processed correctly.

To develop real-world tests, ask specific disciplines to provide complex documents that include large file sizes, special characters and image components. In order to provide a better understanding of the expectations of the system, it's a good idea to employ several different testing teams independent of the core development team.

Many computer system projects stumble or fail because of weak training efforts, experts say.

Develop a user training plan that addresses a full rollout with a large number of users taking on different roles, with ongoing training, Justice advised. And, be sure to schedule the training close to the actual rollout; otherwise people could lose enthusiasm waiting for the system to get up and running.

Finally, migrating legacy documents -- those paper forms with signatures that existed before you had a computer system in place -- is also an important component of CSV and Part 11 compliance programs. Justice suggested identifying key projects with legacy documents and using those as high-profile test cases. Doing this in a phased-in approach will allow you to fine-tune your system as you go. -- Michael Causey