Achieve Stress-free Regulatory Compliance with Medidata Regulated Content Management Solutions
Medidata announced acquisition of CHITA in February 2017 to create industry's first integrated, end-to-end system for regulated content management. Purpose-built for life sciences and now integrated into the Medidata Clinical Cloud, Medidata Regulated Content Management Solutions delivers required processes and controls out-of-the-box by ensuring confidentiality, high integrity, traceability and availability.
Medidata offers a new standard for working with both regulated and nonregulated content in life sciences and is a 21 CFR Part 11 compliant, validated, content integrity and collaboration platform for the modern digital workplace.
With Medidata SOP Management, leverage our pre-built, pre-validated and incredibly perceptive SOP workflow functionality. Our clean, simple and intuitive user experience makes working with regulated life sciences content easy while maintaining compliance. Medidata is built and managed to the highest standards of validation and security and therefore have made it extremely easy to be secure and compliant. With real-time graphical status updates you will always know where things are and what is happening.
With Medidata Regulated Content Archive Service, easily and securely migrate your content (including eTMF content) from external sources while preserving the structure of regulated content. Search, review and approve regulated content from anywhere with your pre-registered tablet or smartphone. All you need in an internet connection. Types of regulated content includes complete TMFs, TMF related content, contracts, CVs, IRB letters and so on.