Computer Compliance

Addressing your computerised system needs

PAC offers a range of services to assist you in achieving GxP computer compliance in order to meet your specific needs. Our experience includes laboratory systems, clinical research–related computerised systems, and computerised systems used in manufacturing processes. PAC has the experience and in-depth regulatory and technical/process knowledge to ensure that your computerised systems are fit for their purpose.

Self-inspection and auditing

Current GxPs call for a comprehensive programme of self-inspection and auditing as part of the Quality Management system. PAC carries out audits against published GxP guidelines, both as part of pre-inspection preparations or as part of the on-going self-inspection programme:

  • Self-inspection
  • Third party audits of vendors (service providers and software suppliers).

QA systems

PAC creates or advises on QA systems and procedures needed for computerised system compliance using either the GAMP approach or procedures based on CMMI or CobiT.

Validation

PAC will help your company to:

  • Develop cost-effective, risk-based validation programmes for any GxP-relevant computerised system.
  • Supervise the implementation of an existing validation programme, providing practical support to complete the work in the most cost-effective and timely manner.

Interim management

PAC can join your team at any phase of a validation project to provide rapid, pro-active, culturally sensitive solutions to problems or to provide temporary staff replacement.

Training

PAC provides tailor-made courses, seminars and workshops on computer compliance related topics, e.g. regulations / guidelines, validation, auditing / inspecting, operational control, system retirement and archiving.