Computer system validation is a regulatory requirement, meeting these requirements can be costly, sometimes adding as much as 40% to the cost of an IT project for inexperienced teams. We can integrate validation into your existing software development life cycle (SDLC) to provide compliance without adding unnecessary costs. If you already have a software validation program, but need an extra hand, we can provide an experienced team that is ready to jump in and get the job done.
What You Can Expect from Us
Our computer system validation and software quality consultants have extensive experience in providing leadership to companies seeking to meet regulatory expectations. Here are examples of the types of projects that our consultants perform:
Computer System Validation
- Validation Program, Procedure, and Template Development
- Functional Requirements and System Design Specifications
- Test Plan Development and Execution (IQ, OQ, PQ)
- Validation Certification Package Development
- Retrospective Evaluation of Legacy Systems
21 CFR Part 11
- Part 11 Gap Analysis and Remediation Planning
- Part 11 Gap Remediation
- Part 11 Global Compliance Auditing
Software Quality Assurance (SQA)
- SQA Program and Procedure Development
- SQA SDLC Design, Implementation, and Evaluation
- Document Control Process Development (eDMS)
- Change Control and Configuration Management Implementation