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Software/ Computer Systems: Validation and Quality Assurance

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Our software services are designed to support the compliance of both software regulated as a medical device, as well as computer-based compliance systems, such as Quality System software and systems (including CAPA, complaint handling, and adverse event reporting systems), clinical data management and analysis software and systems, product testing and manufacturing systems, and electronic records/electronic signatures systems.

We are experienced in the successful development and filing of regulatory submissions for a variety of software medical products ranging from a Low to High Level of Concern, and have worked extensively with many proprietary and commercial software products to develop sound validation plans and design control processes. AccuReg’s software team is comprised of highly-experienced software engineers who are Certified Software Quality Engineers, Certified Quality Auditors, and Certified Quality Engineers as well.

Our software services include:
  • Development and implementation of compliant methodologies based on IEEE, GAMP, and ISO standards
  • Software and computers systems risk management processes and procedures (ISO 14971)
  • Software Quality Assurance support for short- and long-term client needs
  • 21 CFT 820, 21 CFR Part 11 and HIPAA audits and solutions implementation
  • Commercial software and vendor qualification audits
  • Software quality audits and design control audits
  • Development and review of verification and validation programs and procedures
  • Development of Master Validation Plans (MVPs)
  • Design control process and procedure development, implementation and training
  • Software and documentation change control processes and procedures
  • Traceability processes and tools: Development and implementation
  • Retrospective validation of legacy systems
  • IQ/OQ/PQ of equipment and system components
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