ABR’s software services are designed to support the compliance of software and systems for medical devices, Quality Systems, clinical data management and analysis, product testing and manufacturing, and electronic records/electronic signatures. We are experienced in the successful development and filing of regulatory submissions for a variety of medical software products ranging from a Low to a High Level of Concern and have worked extensively with many proprietary and commercial software solution providers to develop sound validation plans and design control processes.

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Our software services include:

• Gap analyses 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

• 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 matrices

• Software and computers systems risk management processes and procedures

• Retrospective validation of legacy systems

• Validation of SAS-based data management and analysis systems

• IQ/OQ/PQ of equipment and system components