MarkLogic announced its Title 21 CFR Part 11 compliance for MarkLogic Data Hub Service, which supports leading healthcare, pharmaceutical, and life sciences companies in meeting U.S. Food and Drug Administration (FDA) regulatory guidance for the management and storage of electronic records and signatures.
The trustworthiness and reliability of electronic records is essential in pharma, life sciences, and healthcare. An electronic record is more than simple data. It can be any combination of text, graphics, data, audio, images, and other digital information. Trustworthiness must be ensured at every step including when the information is created, modified, maintained, archived, retrieved, or distributed. FDA Title 21 CFR Part 11 focuses on the internal controls and requirements associated with doing so. To support the unique compliance needs of each project, MarkLogic Data Hub Service provides organizations with agile electronic record data controls related to access, audit trails, security and other governance – driving value out of more data at less cost. Though this report focuses on FDA guidelines, the same powerful MarkLogic capabilities are beneficial to any regulated industry.
“Data challenges are costing pharma, and life sciences companies millions of dollars and potentially slowing down lifesaving products from coming to market,” said Bill Fox, Vice President and Chief Strategy Officer of Healthcare and Life Sciences at MarkLogic. “From R&D to manufacturing and supply chain, the Part 11 report is clear confirmation that MarkLogic Data Hub Service is the simplest and most secure platform for companies to not only meet stringent regulations, but also accelerate the process of turning their data into a competitive business advantage.”
MarkLogic is used by 5 of the top 10 pharma companies and runs one of the largest data integration projects in the healthcare industry. In addition, MarkLogic is also helping pharma accelerate drug discovery with its recently announced Pharma Research Hub.