In a regulated environment an important part of business risk management is directly related to the organisation's computer systems. An ERP system implementation in this environment will usually be underpinned with a Computer System Validation (CSV) stream of activity which ensures that the system is compliant with regulatory requirements and all the necessary documentary evidence is available for audit.

“Lumenia has provided EirGen with strategic computer systems validation (CSV) expertise since 2009. With their in-depth knowledge of 21 CFR part 11 and EU Annex 11 regulations, they implemented a practical risk based approach to CSV for our GxP critical applications and underlying IT infrastructure. Lumenia successfully led the validation activities on our ERP SAP system, QUMAS Document Management system, and Waters Empower Chromatography system implementations, as well as the qualification of our IT Infrastructure. I would have no hesitancy in recommending Lumenia validation consulting services”.

Patsy Carney, MD, Eirgen Pharma

Lumenia specialises in regulatory software testing and validation services, helping clients ensure that key business systems are fully functional and in compliance with applicable regulations. We employ dedicated consultants, all with GMP/FDA environment experience in preparing validation lifecycle documentation, conducting vendor audits, performing systems assessments, and preparing protocols.

Lumenia specialises in regulatory software testing and validation services, helping clients to ensure that key business systems are fully functional and in compliance with applicable regulations. Our consultants all have GMP/FDA environment experience preparing validation lifecycle documentation, conducting vendor audits, performing systems assessments and preparing protocols.

Deliverables

  • Validation Master Plan.
  • Vendor audit preparation and execution.
  • User requirements documentation.
  • CSV protocol generation and execution (i.e. IQ/OQ/PQ)
  • CSV training for management and engineers (including customised courses on GAMP® 5, 21 CFR parts 11, 210 and 211 and 820).
  • System compliance support.

Benefits to Clients

  • Our proven validation approach certifies computer systems in an efficient and secure manner.
  • Clients are able to put solutions to work more quickly and therefore realise benefits more quickly.
  • Application of best practice methods according to GAMP® 5 and up-to-date industry standards. 

Check out our blog on Computer Systems Validation – Key Questions Answered