Content compliance can be achieved in six steps, says Stephen Bergson, executive VP at Virtify. Global standards and regulatory mandates are evolving. Life sciences companies need to prepare to meet them.
Step 1 is to automate processes and workflow, he explains in PharmaPro magazine, to minimize errors and discrepancies. "Look for an easy-to-use content management environment that has regulatory guidelines built in," he writes, and that includes an XML-based technology backbone for communicating with regulators.
Among the remaining steps are provisioning for collaborative content authoring and review, and providing for adaptation to ever-evolving standards.
Coincidentally, Virtify unveiled standards-compliant software for content management at the DIA show in June, as reported earlier. Its Virtx suite provides compliance with such standards and regulatory mandates as Clinical Trial Disclosure, Electronic Common Technical Document (eCTD) and Structured Product Labeling (SPL).
- here's the article
- see our Virtx coverage