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Pharmaceutical and life sciences companies operate in a highly regulated environment with long product lifecycles. Recent demands for increased public accountability against a trend of fewer new products and expiring patents are threatening traditional profitability and revenue growth. A few of the life sciences-specific regulations include the Food and Drug Administration (FDA) Good Practices (GxP) requirements for laboratory, clinical and manufacturing processes, as well as 21 CFR Part 11 guidelines for electronic records and electronic signatures in the United States. Product development alone can take up to 15 years and $1 billion or more per product and makes time to market a critical profitability factor.
CYA has worked for more than six years within the life sciences industry to mitigate the liabilities associated with traditional enterprise backup and recovery practices for ECM applications. Especially within life sciences, due to the severe human as well as financial risks, there is a zero tolerance for lost or damaged content or its audit trail.
- Meet regulatory demands around the capture, preservation and production of native electronic content within ECM and its audit trails to comply with Sarbanes-Oxley, 21 CFR Part 11, HIPAA, among others
- Ensure timely, complete record recoverability of lost or tampered data to reduce third party auditing and submission refiling costs
- Contain R&D costs by identifying missing, corrupt or non-authentic data within a submission cycle
- Maintain competitive advantage through the accessibility of complete records for customer service
- Reduce operational costs associated with lost or unrecoverable data
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