Ofni - On-Site Compliance Training Course

Access Databases and Part 11 Compliance

Transform any Access Database into an electronic record system with full Part 11 compliance. The course starts with a full, in-depth review of the technical and procedural requirements of 21 CFR Part 11, along with interpretations of how the requirements are applied. All attendees will receive training on best practices in validating Access programs, including best practices and risk assessment strategies to help determine the scope of the validation. (2-day curriculum; can be expanded, upon request, to increase number of databases )

Assessing Compliance with 21 CFR Part 11

Assess your compliance with 21 CFR Part 11, Electronic Record and Electronic Signature systems. The course teaches you to examine your systems for compliance with 21 CFR 11 and to create appropriate Corrective Action Plans. Attendees will learn how to create a list of systems to evaluate, assign priorities for each system, designate responsibilities to appropriate staff, perform gap analysis against the actual text of 21 CFR 11, and determine appropriate corrective actions for any gaps found during the assessment. Most companies find that their compliance assessment can be completed during the training session itself. (1-day curriculum; can be expanded, upon request, to increase number of assessments completed)