The Customer Validation Pack
You validate Ordo for your own intended use, under your own quality system. Ordo Labs supplies the documents that make that a job you can finish, in one pack written for GMP and GLP labs alike.
What is in it
Each document comes as a PDF/A, the controlled copy you freeze in your validation file, and each template as a Word document to write into.
- Validation plan
- Who validates what, and when a release means you re-validate.
- Functional specification
- Every regulated function, one testable paragraph each, with numbers that never change so your URS can cite them.
- Requirements traceability matrix
- Each function traced to its 21 CFR Part 11 and EU GMP Annex 11 clauses and to the tests that cover it.
- Certificate of validation testing
- Certifies that those tests passed for the release you run.
- Installation qualification protocol
- You execute it to confirm that the installed release matches the pack.
- GMP and GLP compliance positions
- Ordo placed against the GMP rules on records and data integrity, and against the OECD GLP Principles with 21 CFR Part 58 alongside for work that reaches FDA. You receive the one that applies to you.
- Security and AI provider positions
- The security controls and their known limitations, and the AI provider, its models, where data is processed and what is kept.
- Data privacy FAQ
- The questions a data-protection reviewer asks first.
- Archived record readability check
- A protocol your archivist runs to confirm that archived records still open and still match.
- URS and PQ templates
- Your user requirements, seeded from the regulated functions, and a PQ protocol with example test cases.
How Ordo is classified
Under GAMP 5, Ordo is a Category 4 configured product with Category 5 elements. The platform is used as supplied, and you configure users, roles, pipelines and templates. The pipelines Ordo writes for your data are the Category 5 part, and you qualify them in your PQ.
What stays yours
Your intended use, risk assessment, URS, PQ, approval and signature, SOPs and training, and periodic review. Where your risk assessment agrees, you can cite Ordo's test evidence for a function rather than test it again.
Every release
Each release comes with a change notice that classifies it against the triggers for re-validation, so you know what to re-check, and the pack is reissued with it.
How to get the pack
The pack is confidential and shared under NDA. To ask for it, leave your email in the form at the foot of this page and tell us you want the pack when we get in touch. Remote and on-site supplier audits are welcome too.
Read next
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Ordo Labs drafts lab reports in your own template from your raw data, links every value to its source file, runs your QC checks and takes the report to electronic signature.
- QC release reports
Ordo Labs drafts QC release reports in your own template from your instrument exports, with every result linked to its source file, your SOP checks run, and second-person review before sign-off.
- Stability reports
Ordo Labs gathers the results of every stability pull into your own report template, keeps every value linked to its source file, and runs your SOP checks before review and electronic signature.
- Bioanalytical study reports
Ordo Labs drafts bioanalytical study reports in your own template from your LC-MS/MS and immunoassay exports, with every value traced to its raw file and sealed at signing.