Predisys
Predisys is a leading provider of quality control, quality management and
collaborative manufacturing analytical solutions for medical device
manufacturers.
The company’s flagship software product, Predisys Medical Device Suite,
is an innovative Microsoft SharePoint based software solution that enables
manufacturers to better support compliance, optimize processes, reduce
documentation errors, increase efficiency and improve product quality.
With fully FDA CFR 21 Part 11 compliant electronic records management,
medical device manufacturers can safely implement paperless systems to
facilitate compliance, traceability and continual improvement while reducing
documentation errors, eliminating missing or lost records, and increasing
overall production efficiency.
The web-centric and cost-effective Medical Device Suite is modular comes
with integrated support for e.g.: Device History Records (DHR),
Device Master Records (DMR), Corrective and Preventive Action
(CAPA), Nonconformance management (NCR), Supplier Corrective
Action Requests, Quality Audits as well as Management,
Collaborative Online Statistical Process Control (SPC) and Advanced
Engineering Analysis.
Keywords: quality control, quality management, SPC, statistical process
control, business intelligence, FDA registration, ICT, MES, CAPA
Contact Information
Predisys Inc
Tietäjäntie 4
FI-02130 Espoo
Finland
Tel: +358 (0) 9 493 3420
Fax: +358 (0) 9 493 34299
E-mail:
info@predisys.com
Web: www.predisys.com
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