Qualification & Validation Services

Qualification & Validation Services

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 core business for Qualification and Validation services are:

  • Build and improve Quality Management System (IT related)
    • Off the shelf QMS (procedures and templates) and software tools (full compliant built)
  • 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
  • Quality review and approval
    • Independent QA officers (for all qualification and validation aspects)
  • Auditing and Assessments
    • GAP assessments
    • Pre-Scans
    • Mock-Audits
    • Permanent Inspection Readiness Program
    • All according to International guidelines (FDA, 21CFR part 11, ANNES 11, ICH, ISO)

We have successfully implemented SAP/ERP systems at national and international companies (EMCM, Fiesland Campina). Next to this, we are a continuous partner for maintaining the validated state of SAP at a global Animal Health Company. (MSD)

Currently we are also involved with a global remediation program for Computerized Laboratory Systems at a large animal health company (MSD Boxmeer & Angers). Moreover, we are in the lead at an international pharmaceutical company (Abbott) for providing, strategies, plans and guidance for System Life Cycle Compliance of IT Systems on a global scale.

All activities are executed according to (if applicable):

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Rescop is active in the following industries