(1-day, 2-day, 3-day, and 1-week curricula available).Access Databases and Part 11 Compliance Transform any Access Database into an electronic record system with full Part 11 compliance.At Ofni Systems, not only do we provide the highest quality compliance services, but we can also train your employees to be proactive in dealing with compliance issues.
(3 hours) Computer System Validation Ensure your compliance with 21 CFR 11.10(a).
Attendees will discuss user requirements, functional specifications and design specifications, requirement traceability, risk assessment, creating appropriate testing protocols, summary reports, and how to maintain your validated systems.
Training includes case studies and best practices for specific computer systems.
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(1-day curriculum; can be expanded, upon request, to increase number of assessments completed) Ofni Systems can create training materials and on-line help files for all of your software, databases, or computer systems.