Standards

Mission3 participates and supports many industry standards and initiatives in order to promote better and more efficient development of Life Science products.

DIA EDM Reference Model

Mission3 has implemented the DIA EDM Reference Model in Mission3 OnDemand and makes available a preconfigured application for our current and future customers.

ICH eCTD

The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format. It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). As of January 1, 2008, the U.S. Food and Drug Administration announced that the eCTD is the preferred format for electronic submissions. To date, over 98,000 eCTD sequences have been submitted to the FDA. Although the agency has not released an expected target date, the FDA revealed during the 2009 DIA Annual Meeting that it is looking at draft legislation to require eCTD. Mission3 fully supports the eCTD standard in our Submission Management and Publishing system.

HL7 Regulated Product Submission

Mission3 participates in the HL7 standards development process and has most recently been involved in the Regulated Product Submission standard.

CFR 21 Part 11

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Practically speaking, Part 11 requires drug makers , medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule.

xEVMPD

Mission3 GlobalTrack has a complete EVMPD Solution that tracks against the EVMPD, EVPRM and IDMP data standards.