Our consultants are experts in planning, project management, implementation, and validation of 21 CFR Part 11 compliant computerized systems for GMP, GLP, and GCP applications.  We have a proven track record of helping clients build quality systems and compliance programs, and implementing or upgrading systems.  From small start-up companies to large firms, QMC has successfully delivered projects on time and within budget requirements.

We will prepare and execute all system development life cycle (SDLC) documents for your application, such as the User Requirements and Functional Specifications, Validation Plan, Installation Qualification, Operational Qualification, Performance Qualification, Traceability Matrix, and Validation Summary Reports. Our approach for validation is based on cGMPs, Good Automated Manufacturing Practices (GAMP), and the latest approach to 21 CFR Part 11.  

For existing systems, QMC can help to review compliance of your program by performing gap analyses, 21 CFR Part 11 assessments, risk assessments, and software remediation.  We can also assist in building procedures and policies for computerized systems - including system validation, change control, and IT security and disaster recovery - tailored to each client's specific needs and existing processes.