QUALIFICATION & VALIDATION SERVICES
We offer consultants with years of knowledge and expertise within the
Qualification and Validation area, this includes Quality Engineering
(facility and utilities), Qualification & Validation
(Computerized systems, CSV, labs, engineering, validation and QA),
IT Delivery & Support, IT Demand & Process Improvement, Auditing and Assessment
(IT Auditing, GMP and GxP audits and assessments)
Our core business for Qualification and Validation services are:
- label Build and improve Quality Management System (IT related)
- label Off the shelf QMS (procedures and templates) and software tools (full compliant built)
- label Qualification and Validation (Computerized systems: IT and Equipment)
- label Including IT applications − lab equipment − production systems − IT Infrastructure
- label Setup validation frameworks (generic approach)
- label SAP/ERP Validation
- label Experience in SAP/ERP/LIMS/MES validations
- label Quality review and approval
- label Independent QA officers (for all qualification and validation aspects)
- label Auditing and Assessments
- label GAP assessments
- label Pre-Scans
- label Mock-Audits
- label Permanent Inspection Readiness Program
All according to International guidelines (FDA, 21CFR part 11, ANNES 11, ICH, ISO).
Please contact us for a free consultation about QA Outsourcing.