SOFTWARE VALIDATION
SERVICE
Clinical
Systems offers Software Validation Services for
the FDA regulated pharmaceutical industry. Our
knowledge of industry practices and standards
along with regulatory requirements, enable us
to create practical and cost-effective solutions
for your validation needs.
We
have been performing computer systems validation
for over 15 years. This experience with the validation
process ensures that your system is thoroughly
tested and documented.
Our
Software Validation Service follows a lifecycle
methodology. A series of documents is generated
to demonstrate that the system is performing according
to specifications. We can assist you in all phases
of the validation process, from the development
of the validation master plan to the user acceptance
phase.
Clinical
Systems can supply skilled individuals and manage
project teams to meet your validation requirements.
Validation services include but are not limited
to:
- Project
Management
- Validation
Master Plan
- User
Requirements & Specification
- Installation
Qualification (IQ)
- Operational
Qualification (OQ)
- Performance
Qualification (PQ)
- Traceability
Matrix / Summary Report
- 21
CFR Part 11 Assessments
- Auditing
Services
- Design
& Development of Procedures
|
Please
Contact Us
to discuss your Software Validation needs.
|
