JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
Mena FN

3-Hour Virtual Seminar On Computer System Validation (CSV) Vs. Computer Software Assurance (CSA): Learn About FDA's Approach To Modernizing Technology, And Benefits For Both ...

As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and ...
technologynetworks

Computer Software Assurance: Perfect Solution or Confidence Trick?

Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...
The Globe and Mail

Computer Software Assurance (CSA) Market Set to Expand at CAGR of 13% Through 2032

The Computer Software Assurance (CSA) industry is experiencing rapid digital transformation as organizations prioritize robust software validation and compliance. Growing regulatory mandates and the ...