Monitoring and consistently applying FDA regulations is not an easy task. BioPharm Systems performs a number of services that will allow you to keep your applications in compliance with FDA regulations, and will keep you abreast of the latest developments in regulatory compliance.
21
CFR Part 11 Assessments
BioPharm
Systems can perform a complete 21 CFR Part 11 assessment of your systems environment:
identifying compliance gaps, developing a plan to bring your applications
into compliance, and assisting with remediation efforts. We also offer a course
to train your staff on 21 CFR Part 11 requirements.
Vendor
Audits
BioPharm
Systems performs vendor audits to satisfy the FDA's requirement for purchasing
vendor applications. BioPharm Systems will develop an audit checklist, perform
the on-site audit, and document the results in a comprehensive audit report.
These audits can be performed individually, or as a part of a joint effort
with other companies auditing the same vendor.
