Electronic Data in Pharmaceutical Manufacturing: Secure Data Transfer (Series Part 3 of 6)
Secure Data Transfer
Even small businesses with a single particle counter or other analyzer can benefit from the secure data transfer that a real-time online monitoring system provides. Real-time monitoring systems can, with great reliability, integrate data from several sources into a centralized and stable database. They remain secure while providing powerful analytical and reporting tools to guide your decision making and product release. As systems become more complex, integrating data from many devices and processes, a centralized data management system becomes critical and even more beneficial. In medium and large companies with many sites, Cloud network connectivity allows data review across the corporation and the globe. This allows many users and sites the advantage of shared data reporting, analysis, approvals, product release and records retention in a fraction of the time it took with manual systems, and with much greater data integrity than legacy or manual systems ever offered.
Complex modern system architectures for use in regulated industries are now designed to be validated and to protect against external tampering. Once validated, they are regarded as safe for data transfer. 21 CFR Part 11 and EU GMP Annex 11 are the most widely used standards for ensuring secure data management. Both regulations apply to records in electronic format that are created, modified, maintained, archived, retrieved or transmitted according to requirements set by the governing bodies.
It’s worth taking a minute to review these cGMP rules governing secure data transfer at the links above. This is to ensure that you’re in compliance while benefiting from the opportunity to improve the efficiency of your data and document operations.