Quality Management
Rescop provides customers with a broad spectrum of consultancy services in the field of Quality Management. These activities are complementary to our Qualification and Validation services and based on the well-established QMS standards as published by ISO, ICH and the US and EU GxP regulations. Our experts do not only have the theoretical background but also bring a wealth of practical experience in QMS implementation and have extended knowledge on how regulators execute QMS assessments.
Our core business for Quality Management services are:
Permanent Inspection Readiness
- Expertise to train and prepare your organization in the successful completion of a Health Authority inspection or Notified Body Certification audit
- Establishment of processes and procedures to maintain compliance and to reach a state of Permanent Inspection Ready
Build and improve Quality Management System
IT Related
- Off the shelf QMS (procedures and templates) and software tools (full compliant built)
General
- Expertise in the development of a key QMS processes such as CAPA & Deviation Management, Change Management, Documentation and Management Review that are compliant to the regulatory requirements but attuned to your organization
Sourcing of QA personnel
- Interim qualified resources (levels: Jr / Intermediate / Sr / Principal) to support your Quality Operations in the fields of CAPA & Deviation Management, Change Management or Document Management