Our Computer System Assurance, Validation, and Compliance services are designed to keep your life science critical operations running smoothly while adhering to the latest industry standards and the new guidance on Computer Software Assurance (CSA) by the FDA and following industry best practices outlined in the ‘GAMP 5’ guide by ISPE.Our commitment to excellence and dedication to quality has fostered a loyal customer base, and all of our business comes from satisfied customers spreading the word and coming back for additional support.
Specifically, 21 CFR Part 11 outlines regulatory requirements for validating all the system governing GxP Process. Just because the software boasts compliance, it doesn’t guarantee flawless performance in your real working environment. You will never know until you test and verify the system against the predetermined requirements. Failing to approach this correctly can result in significant costs.
QCLYNX can help your organization tackle the validation process with confidence and eliminate unnecessary expenditures. Our validation services can range from a complete system review and implementation to basic compliance assistance and consulting. The bottom line, we customize your validation project to meet your existing needs and budget limitations. Our CSV Consultants specialized in GAMP5, FDA 21 CFR Part 11, and PIC/S annex 11.
Our CSV services can assess any of the following items depending on your organization’s goals:
Audit preparation and readiness
Validation Planning
Qualification/Testing and report
Standard Operating Procedures development
Personnel qualifications and/or training
21 CFR part 11 Gap Assessment
Periodic Reviews
Annex 11 gap assessment
Excel Sheet Validation
Data Migration Validation
Cleaning Validation
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