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USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality

Yesterday (13-September,2022) FDA published a new webpage to share the most recent research activities of the Center for Drug Evaluation and Research’s Office of New Drugs (OND).

An OND-led research program (OND-RP) was developed in 2019 to foster regulatory science research (RSR), which addresses knowledge gaps identified during regulatory reviews of investigational or new drug applications.

OND conducts RSR so that regulatory decisions can be made with less uncertainty, while external stakeholders benefit from RSR by providing information that enables a streamlined regulatory review process. This will help to establish a clear regulatory pathway to approval, which helps to stimulate new drug development.

Computer Software Assurance for Production and Quality System Software

Also Yesterday, the FDA issued draft guidance on computer software assurance for computer systems and automated data processing systems that are used for medical device production or quality assurance.

This draft guidance is intended to:

  • Describe "computer software assurance" as a risk-based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate; and

  • Describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR part 820 (Part 820).

Compliance with the Quality System regulation, Part 820, is required for manufacturers of finished medical devices to the extent they engage in operations to which Part 820 applies.

When final, this guidance is intended to provide recommendations regarding computer software assurance for computers or automated data processing systems used as part of production or the quality system

Click this LINK to know more about Computer Software Assurance for Production and Quality System Software.


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