Is software used to produce charts and graphs for quality assurance considered a medical device? If it produces a graph of patient data for retrospective review, is it regulated?
The software itself may not be considered a 'medical device’; however, the software may fall within the scope of 21 CFR Parts 11, and the QSRs 21 CFR Part 820, due to its high risk nature. Risk is high if the output of the software involves the manufacturing or supporting of a QA function or may support (directly or indirectly) within the decision making process.
The only way to know is to conduct a formal (documented process) risk assessment. Determine if the software is a ‘Quality Risk’ (affecting the quality of a process, product procedure) or an ‘Audit Risk’ (risks that may come under audit constraints or which may be audited by an Inspector (internal or agency), and then determine the ‘Business Risks’.
John Cuspilich
Sincerely, John F. Cuspilich, Sr. Consultant RA/QA
FDA.COM
The Auditing Group, Inc.
GMP Publications, Inc. jcuspilich@auditing.com jcuspilich@fda.com
856-596-2333 - 866-GXPNews
06-07-05 02:04 AM - 