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GMP Data Management Experts
is the leading expert group for your PQS, data governance system, or data integrity program including validation of computerized systems in the GxP environment. We fully apply the ISPE GAMP 5 (incl. second edition) approach to your validaton project and concepts.
We offer different concepts, strategies, and methods for compliance management:
- Quality Management consultancy and integration (ICH Q8/Q9/Q10; QbD; PIC/S Aide-Memoire PI 038-1).
- Inspection MOCK audits, preparation plans & support, Pre-Audits, Audit Coaching, Response Letters, CAPA planning and follow-ups.
- IT and System Validation according ISPE GAMP 5 - ERP, MES, CTM, LIMS, DMS, DCS, PLC, cCTD, systems and applications in CGMP, GMP, GDP, GLP, GCP, MEDDEV, GVP.
- Audit Service Center (third party / shared audit programs) - control of outsourced activities under control.
- Vendor and Outsourcing Assessments for outsourced activities, Quality Agreements and SLA management.
- Project / Program Management (ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry, PMI, Prince2)
- Pharma 2.0 implementation (EBR, ELN, Paperless Lab, Data Warehouse)
- Network / Infrastructure Qualification, eValidation, Qualification, Verification, Review services
- Special topics like Spreadsheet or ERP validation, GxP compliant application development, Document Management Systems (MS Sharepoint platform), Analytical Instrument Qualification (USP <1058>), inhouse training programs, etc.
- Qualified Person / Experts’ support & compliance program implementation.
- CAPA, OOS, PQR, APR, deviation management support, training & learning management.
- Regulatory rules and inspections support: Knowledge Management, supporting GxP libraries, independent verification and assessments, preparations and escort services.
- Quality management structures & methods (e.g. QA operations, communication & reporting, trending)
Any project or program will be implemented by our experienced CCS Team in the application of QbD principles, including risk mitigation strategies.
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