QC release reports, drafted from your raw data
A batch is released on the strength of its QC records. Ordo runs the QC checks your lab already uses, taken from your release SOP, on every batch, and drafts the release report from the results. A named reviewer passes or fails every check.
Your own checks, from your SOP
Upload your release SOP and Ordo pulls its QC checks out into a checklist, or you write them in once. They are the checks your lab already runs, so there is no new method to adopt.
Each batch: results in, checks run
Upload the batch's results as they come off the instruments: CSV and Excel exports, PDFs and Word documents. Ordo drafts the release report from them in your template and runs your checks on the results and on the draft, the same way every time. For each check, the AI drafts a finding.
The reviewer starts from the findings
Your reviewer passes or fails each check with its finding in front of them, so the time goes to the checks that look wrong. Any later decision on a check needs a reason, and the audit trail keeps each one with the finding and the model that drafted it. If a file the checks read has changed since the run, Ordo flags it.
Second-person review
21 CFR Part 211 asks for the signature of a second person who has reviewed the original records (§211.194(a)(8)). Give the release report a review and an approval position, and the person who signs the review cannot also sign the approval. Both are electronic signatures under 21 CFR Part 11. Which records need a second-person review, and who is trained to give it, is yours to decide.
What the release decision rests on
A Qualified Person certifies a batch relying on the records behind it. In Ordo that is the signed report, whose results trace back to source files unchanged since signing, and the decision on every check. Running the checks again leaves the earlier run as it was.
What stays with your quality unit
Ordo holds none of your GMP roles. Your quality unit qualifies and validates Ordo and reviews the audit trail, working from the GMP compliance position Ordo Labs supplies under NDA in the Customer Validation Pack.
Read next
- Report generation
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.
- 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.
- Validation
What the Ordo Labs Customer Validation Pack contains, what you still own when you validate Ordo, and how to ask for the pack under NDA.