Software Validation
Procad has many years experience in
validating computerised systems, both Hardware and Software.
We have produced & validated a wide variety of systems
including:
Process Controllers
Automated test equipment
Bespoke Software applications
Off-the-shelf Software applications
Procad Software offer highly qualified and experienced staff
dedicated to software development solutions with complete
validation services. The subject of software validation can
be very complex. Procad has the resources and expertise to
plan and execute virtually any validation project. Procad
personnel have the experience of
prospective/concurrent/retrospective software validation,
white/black box software verification, full life-cycle
software development procedures, and reporting using
established in-house protocols.
Electronic Signatures/Records 21CFR: Part 11
We have gained a lot of experience in regulated environments and are fully trained in all development and validation requirements to FDA 21CFR11 and GAMP guidelines. We can provide / assist with all necessary supporting documentation such as:
- User Requirements Specification
- Functional Design Specification
- Hardware & Software Design
- System Testing
- Validation Protocols & Execution
We also provide supporting services such as:
- Consultancy
- Project Management
- Training