NUTRACEUTICAL
For manufacturers working under 21 CFR Part 111.
THE LOAD
Identity testing of incoming components
Master and batch production records
Specification setting
Label claim support
Supplier qualification
USE CASES
01
Identity test present for each component lot
02
Batch record against master record
03
Results against specification
04
Label claim against formulation and testing
05
Supplier qualification validity
REGULATIONS
21 CFR Part 111
21 CFR Part 101
21 CFR Part 111, including identity testing of dietary ingredients under 111.75; labelling under 21 CFR Part 101.
Release, certify or disposition a batch
Close a deviation, investigation or CAPA
File anything with an authority
Write to your systems outside the transitions you approve
Send a message without a named person's approval
Contact a regulatory authority or a customer
Promote itself to a higher autonomy level
Make you compliant. Compliance decisions and accountability stay with you.
FAQ
Which regulations do the nutraceutical agents work with?
+
21 CFR Part 111, including identity testing of dietary ingredients under 111.75, and labelling under 21 CFR Part 101.
What does the agent check for each component lot?
+
That an identity test is present for each component lot.
Does the agent check the batch record?
+
Yes. It checks the batch record against the master record, and results against specification.
Does an agent make the decision?
+
No. The agents never release, certify or disposition a batch, never file anything with an authority, and never send a message without a named person's approval.
Send an export for one batch or lot and see the workspace run on your own data.
