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