License to Cure for BioPharma
Enable Pharmaceutical and Biotech companies to integrate their Quality Management Systems operations across their global enterprise, fostering compliance with GxP
Pharmaceutical and biotech companies struggle to manage and maintain controlled documents throughout their lifecycle. Functional areas such as Quality Assurance, Manufacturing, R&D, and Regulatory Affairs often create and manage their own silos of content; often with a lot of redundancy that cannot be effectively managed due to disparate systems that do not talk to each other. Developing summaries or universal views for reporting and communicating status of documents across the enterprise can take time and additional resources that increase compliance risk and delay bringing products to market.
License for Document Control addresses these challenges by enabling efficient, complete lifecycle management of controlled documents, from creation to retirement, and ultimately controlled destruction. License for Document Control offers an easy to use, web-based interface that enables viewing, printing, and managing controlled documents across the enterprise, thereby reducing the time and people needed to ensure accuracy and validity of information across all functions. These capabilities include a comprehensive and detailed audit trail to provide irrefutable traceability of all document operations.
License for Document Control reduces development timelines and workflow bottlenecks by enabling simultaneous collaboration by multiple authors and reviewers, as well as streamlining the review and approval process with electronic signatures that are in compliance with 21 CFR Part 11 and Annex 11 requirements.
License for Document Control is a solution that enables pharmaceutical and biotech companies to manage their controlled documents in an efficient and compliant manner across the enterprise. Features such as automated workflows, controlled templates, change control, multi-dimensional permissions, controlled printing, automatic PDF rendering, 21 CFR Part 11 and Annex 11 compliant Electronic Signatures, and an extensive audit trail support GxP as well as non-GxP use across the Enterprise. License for Document Control ensures that every stakeholder has access to the right document at the right time and complete traceability is assured. The solution provides confidence in customer and agency audits with full-text indexing and meta-data searching to find information quickly and easily. Extensive dashboards and reports provide business intelligence to ensure and demonstrate compliance as well as measure business performance.