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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