INTEGRAL SOLUTIONS INTRODUCES MPACT 5.4 WITH ENHANCED FDA COMPLIANCE SUPPORT
by Anonymous

ROYAL OAK, MI., October 18, 2002 – Integral Solutions Inc. (ISI), a full-service quality control and engineering software, training and consulting firm, has released version 5.4 of MPACT (Manufacturing Planning And Control Tool) software to assist manufacturing engineers with the creation and management of quality control documents with additional support meeting Food and Drug Administration standards.

    The integration of MPACT 5.4 and MASTERControl 7.0 will provide regulated manufacturers with a complete package for generating and managing quality control documents. These two software products together provide a sophisticated engineering tool for creating quality control documentation for any manufacturing process seamlessly combined with a comprehensive document control system.

New in version 5.4
•    Document lookups have been customized to FDA specific medical device labels
•    Increased document security
•    Lookups and Custom Labels are password protected
•    Traceability of ALL changes, including additions and deletions
•    21 CFR Part 11 and Electronic Records, Electronic Signature (ERES) Compliance with document control integration
•    Additional part information displayed in Part Family Screen
•    Option to standardize Lookups in central SQL Server or Oracle Database


    "Evolving our manufacturing quality software for the Medical Device Manufacturing Market was a logical next step," said Deborah Farmer, Integral Solutions vice president of marketing and sales. "As automotive standards have become more thorough, we noticed that FDA requirements were very similar. The addition of specific FDA support of electronic data management and CFR 21 Part 11 and ERS compliance addresses an obvious need. Now the Integral Solutions Software Suite is a perfect match for the medical device and pharmaceutical industries."

    MASTERControl, ISI's preferred document control system, is the only software that combines powerful routing capabilities with a completely secure document vault system, protecting the integrity of the master documents by embedding them within the software's database. MASTERControl 7.0's secure database serves as a repository for the final versions of MPACT's master documents, satisfying regulatory requirements for the retention, tracking, electronic signature, and archiving of quality control documents.

    MPACT 5.4 includes two-column controls from the FMEA (Process Failure Modes and Effect Analysis) Third Edition, published by the Automotive Industry Action Group (AIAG). This gives end-users the option to print PFMEA reports in either the two-column format, or the single-column format.

    Product performance surpasses previous versions by as much as 1,000 percent. Printing Control Plans and PFMEAs is now from 100 to 1,000 percent faster, depending on the size of the reports and the end-user's hardware configuration.

Other MPACT 5.4 enhancements include:
•    Group print for instructions: users can now send multiple instructions for a single part to the printer without having to preview them or toggle between screens
•    Full Microsoft® Windows™ XP compatibility
•    Additional e-mail integration: e-mail prompts for MPACT's Question Log and PFMEA actions; information is automatically added to the body of an e-mail prior to the user sending it
•    Added: Q1 2002 PFMEA Evaluation criteria.
(Sort by Severity or Severity x Occurrence)
•    New Instruction Reports

Based in Royal Oak, Mich., Integral Solutions Inc. (ISI) is a privately owned, full-service software, training and consulting firm specializing in meeting the quality planning and control needs of companies worldwide. Established in 1986, ISI has combined its two areas of expertise – quality methods training and software development – and forged world-class software to manage quality data. Today, nearly 17,000 end-users in 27 countries employ various ISI products to meet quality standards, such as ISO,
QS-9000 and Food and Drug Administration requirements.

Visit www.integralsolutions.com or www.qualitydataonline.com for more information about Integral Solutions.




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