Challenges
Based on experiences and research within the industry, the partners of Rescop have identified various common challenges that are faced by the industry regarding compliance of computerized systems with regulatory and business requirements. These include: - (Up-to-date) overview on the company's systems (incl. configuration), their compliance state and (the progress of) compliance processes
- Bureaucracy: the amount of paper involved and time-consuming review, approval and authorization processes
- Depth of compliance activities; what is enough?
- Maintaining compliance throughout the system life cycle
- Keep documentation in line with the changing system
- Traceability of all system and compliance activities throughout the system life cycle
- Store, share and re-use documentation and knowledge on compliance on a corporate level
- Availability resources for compliance activities
Objective
To support companies in facing the above mentioned challenges, Rescop has developed a software product: the Enterprise Compliance Management System (RC-ECMS). RC-ECMS is a corporate web-based database solution which controls, supports and integrates the processes required for establishing and maintaining GxP compliance of a company’s computerized systems throughout their entire life cycle.
Key features of the system: - 21 CFR Part 11 ready, which enables paperless compliance
- can be configured according a company's compliance approach and needs
- can be integrated with existing systems, e.g. SOP system, CAPA system etc.
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