Stability reports without the month of copying
A GMP stability report pulls together results from every time point and storage condition, over months or years. Ordo fills your report template from those results as each pull comes in, and keeps each value linked to the file it came from.
Every pull, in one place
Upload each pull's results as they come off the instruments. Ordo adds them to your template's tables while the study runs, so the report keeps pace with the study instead of waiting for the last pull.
Tables and calculations you can run again
Ask in plain words for the table or calculation you need, such as results by storage condition and time point. Ordo builds it as a pipeline, so the same input gives the same result the next time a pull comes in.
A pipeline Ordo writes is custom code for your data. A person reviews it before it is used, every change to it is versioned, and you qualify it in your PQ.
Checked against your SOP
Your stability SOP's checks can run each time a pull comes in. If your SOP checks the trend across time points, a result that breaks it shows up while the study is still running. Your reviewer decides each check.
Signed, and traceable to the end of the study
Each report is signed under a signature policy you set, with electronic signatures under 21 CFR Part 11. Signing locks the raw results behind it, so a value in an interim report from the first year can still be traced to its file, unchanged, when the study closes.
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.
- 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.
- 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.