Computer System Validation / PLC Validation is becoming Very Essential / Mandatory for the Life Science Companies as Current GAMP 5 Regulation are becoming very Stringent. It is now a big challenge for Pharmaceutical Companies to Install & Maintain fully Automatic Systems for different stages of Production in a Fully Compliant Manner. Here we can support you with our Vast Experience in this field. We validate your Systems in Cost Effective Manner to ensure all Predicate Rules are satisfied with Proper Documentation of Complete Activity.
We have performed Computer System Validation of following System in Leading Pharmaceuticals Companies all over India. Most of these Companies are cleared there Local & International Audits like USFDA, MHRA, TGA etc.
Computer System Master Validation Plan
Gap Analysis & Risk Assessments
Installation & Operational Qualification.
Traceability Matrix.
Related SOP’s.