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• 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.