1. 3DS
  2. インダストリー
  3. Node
  4. License for Document Control

License for Document Control

Efficient and compliant management of controlled documents across the enterprise including functional areas such as Quality Assurance, Manufacturing, R&D and Regulatory Affairs.

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 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. 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.