Computer Compliance services


Addressing your computerised system needs
PAC offers a range of services to assist you in achieving GxP compliance in order to meet your specific needs. Our experience ranges from laboratory systems through to clinical research computerised systems and then to the computerised systems used in the manufacturing processes. In all cases, PAC has the experience and in depth regulatory and technical/process knowledge to ensure that computerised systems and operational practices 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 can carry out such audits against published GxP guidelines, both as part of pre-inspection preparations or as part of the ongoing self-inspection programme. In addition, we will carry out third party audits of service providers and software suppliers.

QA systems
PAC can create, review, update or advise on QA systems and procedures needed for computerised system compliance using either the GAMP approach or procedures based on CMMI or CobiT.

Validation
Whilst validation continues to make ever-increasing demands upon company resources, PAC can help your company to develop cost effective, risk based validation programmes for all primary GxP relevant computerised systems. In addition, PAC can supervise the implementation of an existing validation programme and provide 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
Tailor-made courses, seminars and workshops on computer compliance related topics, e.g. regulations / guidelines, validation, auditing / inspecting, operational control, system retirement and archiving.