Whitepaper: Ever Changing Regulatory Demands
As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In the past, small and emerging life sciences companies might have functioned sufficiently with manual processes and disconnected systems, but may now be unable to satisfy the requirements of regulators whose fundamental shift is a growing focus on electronic processes, data driven decisions and increased transparency to information.
In this Acorn Regulatory whitepaper we look at the demands placed upon companies from the following perspectives:
- Information Technology.
- The Drug Supply Chain.
- The FDA’s Quality Metrics Program.
- Tightening of Medical Device Regulations.
- The Quality Element.
In each of the above listed sections, we assess the changing demands being placed upon companies. While larger companies may find it easier to resource such issues, they present challenges for small and medium sized life science companies.
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