Quality Document Management

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

Pharmaceutical and biotech companies struggle to manage and maintain controlled documents throughout their lifecycle. Quality Assurance, Manufacturing, R&D, and Regulatory Affairs functions often create their own silos of content; resulting in redundancy that cannot be effectively managed due to disparate systems that don't communicate. Developing summaries for reporting the status of documents across the enterprise adds time and resources that increase compliance risk and delay product launches.

Quality Document Management enables pharmaceutical and biotech companies to manage their controlled documents in an efficient and compliant manner. 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 are enterprise-wide features supporting GxP as well as non-GxP.  Enjoy confidence in customer and agency audits with full-text indexing and meta-data searching to find information with ease. Extensive dashboards and reports provide the intelligence to ensure and demonstrate compliance measure business performance.