Open Text Life Sciences Solutions:
Helping you achieve compliant management of all electronic records and documents.
White Paper: 21 CFR Part 11 The interpretation and application of the FDA’s 21 CFR Part 11 regulation that governs the management of electronic records and the electronic signatures that may be applied to them, continue to evolve. While the burden of validation falls on regulated life sciences companies, solutions that address all requirements in a flexible and fully-documented fashion are essential. |
Life sciences companies operate in a highly regulated environment with long product lifecycles. Their operations are both data and document-intensive. Pharmaceutical product development can take up to fifteen years and $1 billion or more per product! Recent demands for increased public accountability against a trend of fewer new products and expiring patents are threatening traditional profitability and revenue growth. Share key information with team members and make the best decisions possible based on all relevant information, while complying with government regulations such as the FDA's 21 CFR Part 11 and conforming to industry standards such as GAMP4.
Find your solution in this Value Chain below
(Background on value chains and why we've organized content this way...read more)
Supporting Functions
In addition, find solutions that support all the phases of the value chain above.