-
Gap assessments of existing software and computer systems
-
Software quality audits and design control audits
-
Software and computer systems validation (ranging from turnkey solutions to supplemental, hands-on support, to project management and oversight)
-
Software Quality Assurance support
-
21 CFR Part 11 audits and solutions implementation
-
Commercial software and vendor qualification audits
-
Design/development/review of verification and validation programs and procedures
-
Design control process and procedure development, implementation and training
-
Software and documentation change control processes and procedures
-
Traceability processes and matrices
-
Software and computers systems risk management processes and procedures
-
Retrospective validation of legacy systems
-
IQ/OQ/PQ of equipment and system components
-
Customized compliance training - SDLC, design controls, validation, Part 11
Our Software Quality team members are known for their hands-on expertise,
their innovative and effective implementation of sound compliance solutions, and interestingly, their senses of humor ...
which can be a welcome attribute when a validation stretches late into the night!
Call, email or reach out through social media for a confidential discussion of how our team can best support yours.
SOFTWARE QUALITY AND VALIDATION
FOR MEDICAL DEVICE, QUALITY SYSTEM, AND
AUTOMATED PROCESS SOFTWARE
AccuReg’s Software Quality and Validation Services are designed to support the compliance of medical-device software
and systems, Quality System software and systems, clinical data management and analysis software and systems, product testing and manufacturing systems, and electronic records/electronic signatures systems.
Our associates are experienced in the successful development and filing of regulatory submissions for a variety of Class II and Class III software medical products, from Low to High Levels of Concern, and have worked extensively with many proprietary and commercial software products to develop sound validation plans and design control processes.
Our Software Quality and Validation services include:
