With increasing regulatory scrutiny and requirements to comply with national and international regulations, more and more companies are moving to replace manual and paper-based processes with automated systems.CS is a recognized leader in providing compliance solutions to the FDA-regulated industry with a global client base and vast experience.

CS follows the FDA-recommended GAMP methodology for all validation services.

CS offers a wide range of services that include validation planning, risk assessments, Part 11 assessments and remediation plans, preparation of validation documents and SOPs, protocol execution, deviation resolution and training. CS regularly contributes to industry conferences, journals, tradeshows and events and is in tune with current FDA thinking and future direction.

CS’s independent consulting services group has extensive experience in providing Validation and 21 CFR Part 11 Compliance services following GAMP 5 methodology.