Quality reviews every record.
Including what the agent did.

Pharma manufacturing

FDA 21 CFR Part 11 records, GxP, data integrity

What the reviewer asks for

An attributable, contemporaneous record of the agent action that the quality unit can review.

What ICA hands them

Attributable, contemporaneous, signed records of every agent action that touches the batch, reviewed by quality and verifiable later.

Where to start

One validated workflow.Quality accepts the record: yes or no.

Beside what you run

ICA is the governance that makes the agent reviewable: every action attributable and time-bound.

Clinical research

ICH GCP, IRB oversight, HIPAA where PHI is in scope

What the reviewer asks for

Who authorized a protocol-touching agent action, and what subject data it touched.

What ICA hands them

Protocol-touching actions held for a named human, the subject data class recorded, and the record verifiable by the monitor.

Where to start

One study, one action class.QA or the IRB liaison accepts the evidence package: yes or no.

Beside what you run

ICA makes every agent decision attributable to an authorizer, by signature.

Medical devices

FDA quality system regulation (21 CFR Part 820, aligned to ISO 13485)

What the reviewer asks for

A complaint or design agent action with a human stop an inspector can check.

What ICA hands them

Complaint-handling and design-control agent actions with a human stop, sealed for the inspector.

Where to start

One complaint workflow.Quality accepts the evidence package: yes or no.

Beside what you run

The QMS keeps the record of the complaint. ICA adds the proof of what the agent did inside it.