Ofni Systems can teach you to 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.

This course is excellent training for anyone who wants to learn how to build fully Part 11 compliant systems for the Pharmaceutical, Biotech and Medical Device industries or for computer systems validation professionals who want to understand how to test programs and what to look for when validating these systems. All attendees will receive a Certificate of Training in 21 CFR Part 11, good for satisfying GXP training requirements.

Benefits


Ofni Systems professionals are experts at compliance issues, including compliance assessment and computer validation. Let our experience provide your employees with a firm foundation when dealing with 21 CFR Part 11.

Training Materials


Ofni Systems can create training materials and on-line help files for all of your software, databases or computer systems.

On-site Training


Training can be provided either on-site or at designated training centers.