Latest release of PTC Windchill reduces effort needed to comply with
new FDA and SEC regulations; enhances integration with PTC IntegrityCollecting and Managing key UDI data from multiple data stores
Automating the submission process with out-of-the-box review
and approval workflows and pre-submission data validation algorithms
identical to those used by the FDA;
Streamlining the management of UDI data, both to accommodate
product versions/variants and to meet the needs of future regulatory
requirements from the FDA and other global agencies.
NEEDHAM, Mass.--(BUSINESS WIRE)--
(Nasdaq: PMTC) today announced the availability of the latest release of PTC
Windchill® product lifecycle management (PLM) software. PTC
Windchill 10.2 adds capabilities to help manufacturers improve
productivity and streamline compliance with new government regulations.
With FDA regulated Unique
Device Identification (UDI) compliance set to take place during
device manufacturers need a solution that will reduce the effort
needed to comply with the law. The regulation specifically mandates that
every unique product, product version, and product configuration be
assigned a UDI to be prominently displayed on its labeling.
In requiring medical device manufacturers to provide UDI-compliant
labeling, the new regulation presents them with the significant
challenge of efficiently handling the vast amounts of data required for
UDI-compliant submissions for each and every product, including unique
product versions, variants, configurations, and packaging.
As a result, PTC has developed a preconfigured, out-of-the-box
technology solution, PTC UDI, to provide for the complete management and
traceability of UDI data while retaining the flexibility needed to scale
to future regulatory and product development changes. This includes: