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Non-compliance results in increased secondary expenses. Life Sciences companies must comply with the regulatory environment to resolve this.
Fremont, CA: Non-compliance leads to sky high secondary expenses, such as non-released stocks, product recalls, and other issues, as well as concerns with authorities suspending production. To address this, Life Sciences organizations must shorten time-to-market, reduce costs, and improve business models while remaining competitive and adhering to a tumultuous regulatory environment. Life sciences organizations operating in a GXP-regulated environment must ensure that their Enterprise systems supporting critical business activities are always compliant.
The need for compliance management in life science companies:
Enterprise systems are continuously changing due to new business requirements, periodic software/infrastructure updates, and other factors that must be managed through a strong change management process to maintain compliance. Updates happen every quarter, especially for firms using Cloud Applications, and the changes must be regression-tested and authenticated to preserve compliance. All changes to the systems must be verified and qualified to fulfill the Computer Systems Validation criteria to ensure continued compliance in the United States under FDA 21 CFR Part 11 rules. Computer System Validation (CSV) is a documented procedure for ensuring that a computer system performs exactly as it is intended in a consistent and repeatable manner. Authorized SOPs govern all system changes with defined processes and controls.
Changes to specifications and systems are reviewed and approved as part of the Validation process. Planned minor and major releases and unanticipated Emergency Fixes are all part of the Enterprise platforms' ongoing evolution. There are also important project-driven changes, such as modernizing or expanding the current footprint. The events that trigger the change must be evaluated for their influence on the Core Business Process, and any new functionality must be enabled before the scope of Testing can be determined and test execution scheduled. While it's critical to include regression testing and a formal validation procedure to ensure continuous compliance as the release cycle evolves, it's also critical to avoid slowing down Time-to-Market when delivering changes to production.