Industry-Leading eSource Software Company Receives Part 11/Annex 11 Verification

It's the prevailing trend: eSource, eRegulatory, and various electronic solutions have become standard in clinical research sites. Sponsors and research sites now anticipate software providers to develop their applications in alignment with Part 11 and Annex 11 standards. Additionally, there's a growing expectation for software companies to furnish an independent confirmation of compliance as a prerequisite for software acquisition.

Although CRIO, Inc. had been offering its Clinical Research IO eSource system under its compliance program, the program itself had not undergone validation by an independent third party.

As a result, CRIO, Inc. reached out to the Advarra® team to carry out an independent evaluation of the company's computer system validation program to ensure its alignment with the necessary standards. Uncover how an independent confirmation of compliance was able to open up new opportunities and instill confidence in customers interested in integrating CRIO, Inc.'s eSource system into their own computer software validation strategy.