Manufacturing Industry
A software prescription for FDA compliance: for medical device manufacturers, a new SPC program maybe just what the doctor ordered.(Quality Innovations)(Food and Drug Administration)(statistical process control)(InfinityQS International releases new statistical software)
Quality, March, 2004 by Adams, Larry
New electronic signature requirements for medical device manufacturers have led to the release of a number of new software packages, including the release of a statistical process control (SPC) package that meets the standard while offering statistical analysis and enhanced lot geneology.
Medical device manufacturers are working to comply with the Food and Drug Administration's (FDA) standard, 21 CFR Part ll. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted, and it also applies to electronic records submitted to the FDA.
InfinityQS SPC 2004 from InfinityQS International (Fairfax, VA), an upgrade of its 2002 version, is meant to satisfy the 21 CFR Part 11 regulation while giving...
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