What are OpenText Regulated Documents?
Highly regulated industries such as the life sciences industry is subject to strict regulations that dictate how, when, and under what circumstances electronic documents can be authored, updated, approved, published, archived, and destroyed. In the race to market, regulated industries need to make regulatory compliance an integral part of their document management and control processes to reduce risk, gain competitive advantage and bring new products to market faster. Achieving compliance is not just a business issue for the life sciences industry as several other regulated industry sectors, such as financial services and government agencies, are also facing similar challenges.
the ability to Manage and Control regulated documents throughout their lifecycle while accelerating time-to-market and reducing total cost of ownership providing substantial benefits such as:
Industry Compliance: A comprehensive system for controlled documents ensures compliance with 21 CFR Part 11 and reduces regulatory risk.
Enterprise Content Management (ECM) platform: A full-featured, industry-leading, highly scalable, web-based document management platform provides a single repository for securely organizing, controlling, and sharing enterprise content.
Configurable Workflow: A configuration-based solution reduces the initial validation effort and eliminates the need for additional re-validation when workflows change greatly reducing time to market and total cost of ownership.
Ease of Use: Design workflows graphically with drag and drop icons. Access regulated content and review and approval steps via familiar desktop applications such as Microsoft® Office and SAP® .Records Management: Enable compliant lifecycle management of all enterprise content, by proactively enforcing corporate and regulatory policies and procedures without impacting the way users work. Streamline records retention and destruction processes.
Controlled Viewing and Printing: Simplify compliance enforcement through efficient configuration of viewing and printing rules and leveraging records management classifications. Only allow viewing and printing of approved and effective SOP’s and other controlled documents.
Learn more about OpenText Regulated Documents for the Life Sciences Industry from this White Paper. Discover how Team RDS is helping organizations achieve compliance. Contact Us Today.