Closing the Loop on Compliance
- Taking an ROI driven approach to managing compliance technology & processes
- The rise in GMP, marketing, and ethics violations have resulted in financial penalties causing a direct & significant financial impact on companies in heavily regulated industries
- The growing influence of the FDA on global Life Sciences
- GMP Violations – On the Rise
- The 7 Deadly Sins (The 7 most common violations cited in the 483’s and warning letters issued)
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Effective Compliance can be achieved by closing the loop which means companies must:
- Focus on key issues before risks crop up.
- Address the complete end-to-end transactions, right from the origin.
- Appropriate solutions should be implemented.
- Optimum and appropriate use of available resources and options
- The process should be simple, standardized, reused, and needs to be communicated wherever possible.
A cloud-based Compliance, Quality & Risk Management platform unified with R&D, Labs, Predictive Risk, Clinical, Manufacturing, and Document Management