Validation of computerised systems

Proven qualification concepts, efficient and audit-proof

For many years engineo GmbH has developed and implemented computer systems and software for pharmaceutical and medical devices. Therefore the validation of computerised systems is what we do on a daily basis. Due to these many years of experience we know the regulatory requirements in detail and implement those in efficient, audit-proof and in the meantime frequently proven validation concepts.

Our GMP conform quality management system according to GAMP is audited regularly with excellent results. It is subject to a continuous improvement process and is constantly refined based on our experience gained in on-going projects, and adjusted to the current regulatory requirements.

For the training and development of our staff we have put an internal training system in place which includes regular external training sessions and cooperation with the relevant associations (GAMP D-A-CH, ISPE).

Consulting and project management for the pharmaceutical, medical engineering and food industries

Our service includes implementing all aspects of a life cycle of computer systems and software and compiling the appropriate documentation:

  • validation plan and risk analysis
  • user requirements, functional and design specifications
  • software development
  • code review and software test
  • DQ, IQ, OQ, PQ
  • quality report
  • change control and configuration management

Furthermore we would be happy to support you in the following areas:

  • set-up of quality systems for computerised systems and software
  • developing SOPs and training for your staff
  • preparation of inspections (analysis of critical points) and follow-up (correction of defects/findings)
  • carrying out supplier audits

Here are some typical examples of projects we handle:

  • process control systems and PLC
  • PIMS, LIMS, Excel, data bases
  • GMP, GLP and GCP Software
  • Software for medical devices, laboratory and analytical equipment