Computerised System Validation

Computerized System Validation is not just testing or producing some paper as for qualification evidence, but an unique opportunity to verify the level of Compliance of outstanding process, provided that you have the appropriate competences and resources.

K2C consultants may help you because of a long experience of Validation methodologies and associated guidelines or best practices (e.g. GAMP). The continuous update on regulation and standard of our personnel is ensured by the collaboration of K2C with Industry Associations, Institutions and Universities.

K2C consulting services for Computer System Validation include:

*  Definition of company policy and procedures

*  Analysis of User Requirements

*  Software selection and supplier qualification/audits

*  GxP Risk Assessment of computerized systems and outstanding process

*  Planning and Reporting (VMP, VP, VR)

*  Review of supplier system specifications

*  Definition of of Test Plans, Test Specifications (IQ, OQ, PQ) and support during test execution

*  Definition of ongoing SOPs for computer systems

*  Validation of Legacy Systems

*  Network Validation

*  Preparation of regulatory inspections

Contact us for more information.