How it works
The validation pack
The pack has documents for the whole platform and a set for each module.
For the platform: the Validation Master Plan; the Validation Strategy; the Vendor Validation Package Overview, which describes the pack and splits the work between Complere and your company; and the Customer Validation Template, which your company completes for the installation qualification (IQ), user acceptance testing (UAT) and performance qualification (PQ) of its own Complere.
For each module, the Platform among them:
| Document | What it is |
|---|---|
| URS | The User Requirements Specification: what the module must do. |
| FRS | The Functional Requirements Specification: the link from each user requirement to the configuration that meets it. |
| Risk Analysis | The risk of each function, which sets how much it is tested. |
| CS | The Configuration Specification: the module's settings that your company can configure. |
| Validation Plan | How the module's validation is planned and who does what. |
| Test Plan | What is tested, and how. |
| IQ Protocol | The Installation Qualification Protocol: the installation checks. |
| IQ Test Script | The Installation Qualification Test Script. |
| OQ Protocol | The Operational Qualification Protocol: the operational tests. |
| Platform-Level OQ | The Platform Operational Qualification Test Script: the module's platform-level operational tests. |
| PQ Test Script | The Performance Qualification Test Script: the tests of the module in use. |
| TM | The Traceability Matrix: each requirement traced to its risk and its tests. |
| TSR | The Test Summary Report: the outcome of the testing. |
| VSR | The Validation Summary Report: the outcome of the validation. |
| ATS | The Audit Trail Specification: what the module's audit trail records. |
| Part 11 Checklist | The 21 CFR Part 11 Compliance Checklist: the module against each Part 11 requirement. |
| Customer UAT | The Customer User Acceptance Test (UAT) Template: the tests your company runs for its own use. |
| Release Notes | The module's features, fixes and known issues for the release. |
The pack covers the product as Complere supplies it. Your company's own configuration, intended use and user acceptance testing are your company's part; the Customer Validation Template and each module's UAT template are written for that.
The release notes
A known limitation that changes how you do a task is noted in that task's article. The release notes, which come with the validation pack, also list the known issues of the release.
The help PDF
The help PDF is one PDF of every article on this site for that release. Each article in it carries its KB id, the release it applies to, its review date and its change history, so your quality team can keep it as a controlled copy.
Asking for them
Write to Complere support with your company name, your release (the release page names it, for example "Release 1.0.0") and, for the validation pack, the modules your company uses — see Ask Complere support for help.
If something is different
Your company runs a different release from the one on the release page.
Name the release you run when you write.
You need help with a task in Complere, not documents.
Search this site, or write to Complere support (see Ask Complere support for help).