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Computer System Compliance Consultancy

We can help you to frame your Computer System Compliance programs to suit your existing QMS documentation and making it an integral part of your quality documentation. We can assist in identifying broad strategies at corporate level and translating them into operational methodologies at plant level. We can help in preparing Validation Master Plans, Risk Assessment Strategies, Standardized Test Protocols and IT SOPs.

We can work with you in specifying, selecting, developing, implementing, validating and maintenance of computerized systems used in FDA compliant applications.


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