FDA REGULATED MANUFACTURERS
To help FDA-regulated manufacturers meet the challenges of stringent and continually evolving regulatory requirements, CPS staff who combine practical system expertise with current regulatory knowledge, are ready to supply automated systems conformance services.

21 CFR Part 11 Gap Assessment and Remediation
Part 11 addresses the guidelines and criteria by which electronic records and signatures, including handwritten signatures recorded in an electronic format, may be accepted by the FDA as a valid equivalent to traditional paper records and signatures. CPS is intimately familiar with the current compliance impact from 21 CFR Part 11 to system design, implementation and validation.

21 CFR Part 11 assessments are conducted by CPS using a combination of our integration engineers and our validation consultants. CPS makes Part 11 remediation solutions reasonable, timely and cost effective.