Our document box of system validation
Validation/qualification: Why is qualification of the Empower system not enough?
The CSV box contains detailed document templates for planning, implementing and documenting a computer system validation. These include:
- Validation plan
- User Requirements Specification
- Functional specification
- Risk Analysis
- Supplier Assessment Waters
- System Design Specification
- Configuration specification
- Installation Qualification Plan
- Operational Qualification Plan
- User Acceptance Test (UAT) plan
- Installation Qualification Report
- Operational Qualification Report
- User Acceptance Test (UAT) Report
- Trace Matrix
- Validation report
- System Release Document
In addition to the documents as a Word template, the package includes 10 days of support from a zifo CVS specialist who will use his experience to give you valuable information on configuring and setting up your Empower system. He will work with you to adapt the templates to your needs and environment.
Upon request and for a separate charge, he will also carry out the validation.
Our Products
Empower 3 manual
Empower 3 Custom Fields Guide
SOP box
CSV box
CIQ – Customized Instrument Qualification
Peakprovider 2.0 for Empower
Rhizomer
CLEAR – Efficient Empower3 Result- and Audit Trail-Reviews
CUT – Content Uniformity Template
