Incoming material disposition
Check botanical and ingredient CoAs against your specification, with identity testing tracked for every dietary ingredient.
Dietary supplement quality
Ovada is an AI quality agent for dietary supplement manufacturers. It applies your approved procedures and specifications, gathers evidence, follows up for missing information, and prepares review-ready records for your quality unit.
Lot C24117 · microbial limits result needed
Your COA for lot C24117 doesn’t report microbial limits (TAMC/TYMC), which our specification RM-SPEC-0142 v3 requires. Could you send a revised COA?
Sent within approved autonomy · recordedPlease see attached.
COA_C24117.pdfThanks. This is the COA we already have. Could you send the TAMC/TYMC results for lot C24117?
Follow-up · same dayRevised COA attached.
COA_C24117_rev2.pdf!Same COA as received 14 Sep. Microbial limits still not reported.
✓TAMC 120 cfu/g · TYMC <10 cfu/g. Within specification.
Linked to the record · ready for dispositionSupplement quality work happens between systems: SOPs, specifications, supplier records, certificates of analysis, email, shared drives, and a QMS. Ovada does the work between them. Your QMS stays the system of record.
Check botanical and ingredient CoAs against your specification, with identity testing tracked for every dietary ingredient.
Keep supplier qualification current so you can keep relying on their CoAs under Part 111.
Rebuild what happened in a batch from the batch production record and route it for quality control review.
Turn complaints and recurring deviations into investigated, documented corrective actions.
Catch SOP changes, expiring supplier documents, and relevant FDA 483s between audits.
These are five of Ovada’s 62 skills. The ones that matter most depend on your operation. See all 62 skills.
Part 111, mapped
Where the regulation meets your daily work, what Ovada takes on, and who decides.
| Requirement | The daily work | What Ovada does | Who decides |
|---|---|---|---|
| 111.70 · Specifications | Set specifications for components, in-process points, and finished batches | Checks each CoA and test result against the active specification | Quality control personnel |
| 111.75 · Verifying specifications | Identity test every dietary ingredient and qualify suppliers before relying on their CoAs | Tracks identity testing per lot and keeps supplier qualification current | Quality control personnel |
| 111.113 · Material review | Review deviations and unanticipated occurrences, then decide disposition | Gathers the records and drafts the material review | Quality control personnel |
| 111.255 · Batch records | Prepare and review a complete batch production record for every batch | Checks every entry against the master manufacturing record and follows up on gaps | Quality control personnel |
| 111.560 · Complaints | Review and investigate product complaints | Assembles the complaint, batch, and distribution records for the investigation | A qualified person |
Your quality unit keeps authority over every disposition and signature, with 21 CFR Part 11 electronic signatures built in. Not sure where you stand today? Start with a Part 111 gap assessment, read the subpart-by-subpart Part 111 guide, or see how GxP compliance software keeps the work controlled.
Contract manufacturers juggle many products, customers, suppliers, specifications, and approval requirements. Ovada is configured around each workflow.
Ovada applies the right procedure and customer specification for each product, gathers the required evidence, and routes the work through the correct authorization path.
It works within your quality agreements and customer requirements. It does not replace them or your quality unit’s judgment.
It is software that helps supplement manufacturers manage controlled documents, specifications, supplier records, material reviews, deviations, CAPAs, and approvals. Ovada adds an AI quality agent that does the evidence-heavy work across your connected systems.
No. Your QMS, document repository, or drive remains the system of record. Ovada works across those systems to prepare review-ready quality work.
Yes. Ovada is configured around the procedures, product specifications, customer requirements, and authorization paths for each contract manufacturing workflow.
No. Qualified personnel keep responsibility for the quality system, material dispositions, investigation conclusions, risk decisions, and every signature.
Yes. Ovada compares reported CoA values with the active specification, gathers supporting evidence, flags missing or out-of-specification results, and prepares the material for qualified disposition.
Bring one repetitive, evidence-heavy process and watch Ovada do the controlled work leading up to approval.