Global
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JapanOpen Text Solutions for Pharmaceutical & Life Sciences: Compliance
Product safety is paramount for life sciences products, with efficacy coming a close second. Government regulators demand a high level of accountability—simply put, if an event or assertion is not verifiably documented, it cannot be proven. These assertions are increasingly applicable not only to paper and electronic records, but to transactions that may be contained in e-forms, emails, and sometimes even voice messages and instant messages (IM).
GxP:
Over several decades, good practices regulations (GxP) have developed that cover all processes in the laboratory and the clinic, and during manufacturing and distribution, that could impact product safety and efficacy. Complying with regulatory requirements, which may differ between jurisdictions, can be onerous, but consensus guidance such as GAMP4 can be helpful.
e-Records and 21 CFR Part 11:
The ongoing transition from paper to electronic documents and records has created an additional layer of complexity. More recently, the demands for increased public accountability and the application of general, cross-industry demands such has Sarbanes-Oxley (SOX) have further increased the importance of achieving compliance.
Open Text helps you address these challenges with a broad range of document and records management solutions that address paper and electronic records in both formal repositories as well as in email, collaboration and messaging systems.
The electronic common technical document format (eCTD) for regulatory submissions is an early example of increasing global standardization within the pharmaceutical industry. Many other standards are expected, especially for specific types of data. However, as the eCTD experience has shown, uniform global standards may be incomplete so that critical regional differences in implementation remain. The transition to new standards therefore present challenges in managing consistent change across a global organization without losing track of remaining regional requirements.
Whitepaper
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.
