Bioanalytical study reports, traced back to the raw run

Bioanalytical labs write the same kind of report study after study: the method, the runs, their acceptance and the results. Ordo drafts the study report in your own template from the exports of your LC-MS/MS and immunoassay runs, and links every value back to the file it came from.

From raw export to study report

Upload the run exports and the study documents as the study goes. Ordo fills the template from them and cites the file and passage behind each value it drafts.

Raw data stays raw

A table Ordo extracts from a document never takes the place of that document. When the report is signed, the original is locked with every other source file behind it: it can no longer be deleted, and you can show it has not changed, for as long as the study is archived in Ordo.

Amendments, not edits

For studies that reach FDA, 21 CFR Part 58 asks that a correction to a final report be a signed, dated amendment stating its reason (§58.185(c)). In Ordo a correction is a new version with its own signature chain and a pointer to the original, and its reason is recorded on that version's signature. The signed original is never edited.

For your QA unit and your archivist

Your QA unit can be given read-only access to all study content and its audit history. Your archivist gets a recorded appointment, an archive index, and a protocol for checking that archived records still open and still match.

Who holds GLP status

GLP status is held by your test facility and confirmed by its national monitoring authority. No software can hold it, and Ordo holds none of the GLP roles. What Ordo Labs supplies is a GLP compliance position that maps Ordo against the OECD GLP Principles, with 21 CFR Part 58 alongside for work that reaches FDA. It comes under NDA with the rest of the Customer Validation Pack.