Qualification & Validation

Rescop provides customers with a broad spectrum of consultancy services in order to support their organization with respect to compliance, qualification and/or validation and calibration of e.g.: utilities, equipment, Information systems and IT Infrastructure. Our consultants are highly qualified and trained in the applicable legislation, standards and guidelines such as – but not limited to – FDA’s 21 CFR part 11, Eudralex GMP Annex 11 & Annex 15, ISPE GAMP-5, OECD GLP Consensus Document no. 17 and PIC/s.

Our core business for Qualification and Validation services are:

Qualification and Validation (Computerized systems: IT and Equipment)

  • Including IT applications – lab equipment – production systems – IT Infrastructure
  • Setup validation frameworks (generic approach)

SAP/ERP Validation

  • Experience in SAP/ERP/LIMS/MES validations

Qualification and Validation of Utilities

  • Experience in the risk-based qualification / validation of utilities such as water systems, compressed air and HVAC systems

Life Cycle Process Validation (LCPV)

  • Experience in LCPV stage 2 (in both “Equipment Qualification” (stage 2a) and “Process Performance Qualification” (stage 2b)) and in LCPV stage 3 (“Ongoing Monitoring” also known as “Continued Process Verification”. Though lesser experience in LCPV stage 1 (“Development)
  • Experience in risk-based validation of processes in line with the latest regulatory expectations

Sourcing of Qualification & Validation personnel

Interim qualified resources (levels: Jr / Intermediate / Sr / Principal) to support Qualification & Validation Operations

Send us a message to see how Rescop can help you regarding our consultancy services ‘Qualification & Validation’: