The Part 11 Advisor software comes with on-site training on 21 CFR Part 11, as well as training for program administrators. Typically we allow 3–5 days for most implementations.
We start by setting up the software at your site. In most cases, the list of systems to evaluate has been provided ahead of time and has already been added to the system — we can start immediately with program testing and training for the program administrators. Group training for everyone else usually happens on the afternoon of Day 1 or early in Day 2.
Once training has been completed, we begin scheduling time to meet with each person who has been designated as a program assessor. These are the people who know their software better than anyone else (the “gurus”) and are most qualified to complete the assessments.
We meet with each one of these people to review their assessment (most of them do an excellent job the first time and do not require edits), but more importantly, we help them build their corrective action plans for addressing any gaps found during the assessment.
After we have reviewed several systems with the system owners, we get the program administrators to take over. Now they get a chance to audit the systems using techniques we used on Day 2, and we simply help them polish their auditing skills and answer any tough questions that may arise.
Many companies only need three days to get up and running. However, for larger companies with numerous systems and/or higher numbers of people that need training, we allow for a few extra days to perform additional training or review more systems. In some cases, we have been asked to do all of the assessment reviews and create a strategic plan for the entire department or company.
Part 11 Advisor – Assess your compliance with 21 CFR 11.