Regulatory Compliance Manufacturing Software

Software for the preparation and maintenance of manufacturing systems that are subject to specific government regulations. These typically include regulations for the production of food, pharmaceuticals, medical devices, and other health- and safety-related products.

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• IBS America, Inc. - Enterprise compliance management software helps companies manage quality processes and comply with FDA 21 CFR Part 11, FDA 21 CFR Part 820, and the Sarbanes Oxley Act.
  
• MASBS - ISO 9000 and AS9000 software tools. Consulting and training
  
• Advanced Software Designs - Formula management module that streamlines product development. Other modules includes regulatory compliance (MSDS/labeling), lab analysis, nutrition labeling, nutrition database.
  
• 3Tier Technology - Browser based software for document management, ISO-9000, quality control, and process improvement.
  
• AssurX, Inc. - CATSWeb automatically maintains a secure, time-stamped audit trail of all changes made to any electronic record for compliance with FDA 21 CFR Part 11.
  
• Cognica - Delivers information for routine operations, maintenance, health and safety, training, new works design, environmental auditing. Multimedia presentation techniques.
  
• Qualtrax, Inc - Offer compliance management software including document control, audit management and training management solutions.
  
• March Quality Services - Support APQP / PPAP forms disc and QS-9000 supplier forms disc.
  
• ISO 14001 Resources - An ISO 14001 implementation guide. Example documentation, EMS procedures, implementation software simplify certification.
  
• Native American Technologies Inc. - Weld measurement and quality control systems (Arc, resistance, laser, friction stir, other). Real-time weld monitoring with networked factory information system for weld quality, logistics, preventive maintenance planning.
  
• Quality Link Software - Quality management software manages any quality system.
  
• MACPRO Software - Manufacturing, ERP, quality assurance, and regulatory compliance software solutions for mid-sized and large businesses.
  
• Sparta Systems - TrackWise corrective action software is fully customizable to fit your business. Track nonconformance issues, defects, audit results, findings and action items in general.
  
• C-Spec - Software automatically creates and manages QA/QC documentation for compliance with ASME IX, AWS D1.1, and EN 287 / EN 288 codes.
  
• Applied Computer Services, Inc. - Business Pro software provides solutions to process documentation, labor standards, work measurement, line balancing, estimating, quoting, ISO compliance, process planning and revision control needs for MRP and ERP systems.
  
• Harrington Group Software - Quality management Software to handle web-based and networked corrective action, auditing, calibration, supplier, maintenance, training, document control, and quality cost issues.
  
• Techview Corp - Software products for manufacturing documentation to meet ISO and QS 9000 standards. Creating, organizing, viewing CAD drawings, text, scanned images.
  
• Busitech - Quality Window statistical based software helps companies to minimize process/product variation.
  
• Gael Ltd. - Q-Pulse Compliance Management Software supports system processes including Document Control, Audit and Corrective/Preventive Action (CA/PA) Management.
  
• Computing Solutions, Inc. - LabSoft NR software manages USDA FSIS Noncompliance Record (NR) Form 5400-4 as part of their HACCP program.
  
• Quality Systems International - Developers of Lotus Notes/Domino software for document management, process improvement, quality and environmental records, and compliance with ISO-9000, ISO-14000, and QS-9000 business standards.
  
• MasterControl Inc. - MasterControl provides GxP process and document management software solutions for life science companies.
  
• TrackPro - Track the status of recurrent items such as calibrations, maintenance, and reminders. Keep these under control and meet the demands of regulations: QSR, GMP, ISO 9000, and QS 9000. Windows 95/98/NT 4.0. Track up to 150 items.
  
• FactMinder - Software engineering company developing cooperative partnerships to deliver audit management and traceability solutions.
  
• Embella - Offers DisEMinate management web services to facilitate regulatory compliance.
  
• Lennox Hill Ltd. - Web-based document control software and quality management system for professionals involved in ISO9000 and other quality, environmental, compliance and standards management.
  
  

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