Lot Compliance
List Lot Documents
Compliance documents filed against a lot — Certificates of Analysis, batch records, production photos.
Upload Lot Document
File a compliance document against a lot.
Update Lot Document
Correct a document's metadata — type, issuer, reference, issue and expiry dates.
Remove Lot Document
Detach the document from THIS lot. The stored file is deleted only when that was its last link anywhere — removing a Certificate of Analysis from one lot of a batch leaves the other lots certified.
Get Lot Document Link Count
How many records still reference this document, so a client can state whether removing it from this lot will unlink it or permanently delete the file.
Link Batch Document to Lot
Adopt a document already filed on a sibling lot of the same batch.
Get Lot COA Results
The quality specification that applies to this lot, merged with any results already captured.
Record Lot COA Results
Record the values read off a Certificate of Analysis, evaluate them against the product specification, and gate the lot.
Record Lot Receiving Verification
Record your own identity verification of a received lot, under 21 CFR 111.75.
List Lot Retention Samples
Reserve samples held against a lot under 21 CFR 111.83.
Create Lot Retention Sample
Record a reserve sample held against a lot.
Update Lot Retention Sample
Update a reserve sample or advance its status through retained, sent to lab, returned and discarded.
Delete Lot Retention Sample
Remove a retention sample record. The physical sample is unaffected.
List Retention Samples
Reserve samples across every lot, with a filter for samples past their retention date and still physically held.
List Compliance Documents
Every compliance document across all lots and suppliers — Certificates of Analysis, batch records, production photos and supplier certificates.
List Compliance Document Types
Every document type with its display label and colour, for building a type filter or upload picker.
Download Compliance Document
Stream a lot-linked compliance document.
List Product Specifications
The quality standard a product's lots are judged against — one row per analyte.
Create Product Specification
Add an analyte to a product's quality specification.
Update Product Specification
Update one analyte of a product's quality specification.
Delete Product Specification
Remove an analyte from a product's quality specification. Results already recorded against it are kept as history.