Summary
In short
- A regulatory inspection record is a record used in KnowComply that records a visit by a regulator, including what was inspected, what was said and any orders issued. It is built against Regulatory practice and forms part of the Management System Governance programme.
- Completed on the day of the visit. Carried out by the host with the compliance lead.
- The template holds 53 fields across 5 sections, with findings raised repeating for each entry.
- Scoring is order count, where high is bad.
- Regulatory practice is regulatory practice. Established expectations of regulators rather than a written standard.
- It connects to the rest of the library: feeds CAPA.
What it is
What it is
What is a regulatory inspection record?
A regulatory inspection record is a record used in KnowComply that records a visit by a regulator, including what was inspected, what was said and any orders issued. It is built against Regulatory practice and forms part of the Management System Governance programme.
When is a regulatory inspection record completed?
A regulatory inspection record is completed at the moment the event happens, rather than reconstructed afterwards. Completed on the day of the visit.
When to use it
When to use it, and when not to
This record is one step in a larger programme. Using it for work that belongs to a neighbouring template produces records that are hard to report on later.
Use it for
- The event or activity this record covers has occurred, or is about to
- A new record is needed; each one gets its own ID in the form RINS-2026-000
- You are running the Management System Governance programme and this is one of its steps
- A linked record needs this one to exist: feeds capa
Not for
- Legal and Other Requirements Register, which lists every law, regulation, permit and commitment that applies to your operation.
- Compliance Obligation Assessment, which assesses how each legal requirement applies to you and what you do to meet it.
- Compliance Evaluation Record, which records the periodic evaluation of whether you actually comply with each obligation.
- Anything outside KnowComply, which belongs in the workspace that owns that process
Standards
What it is built against
Regulatory practiceRegulatory practice
Established expectations of regulators rather than a written standard.
FAQ
Frequently asked questions
What is the regulatory inspection record template based on?+
It is built against Regulatory practice. Regulatory practice is regulatory practice. Established expectations of regulators rather than a written standard.
What sections does the regulatory inspection record contain?+
There are 5 sections: header, conduct of the visit, outcome, findings raised, response. Together they hold 53 fields, 34 of which are required.
How often is a regulatory inspection record raised?+
A new record is raised at the moment the event happens, rather than reconstructed afterwards. Each one is given an ID in the form RINS-2026-000, so it can be traced and referenced from other records.
Which programme does the regulatory inspection record belong to?+
It is part of Management System Governance, Safety Programme Management. One integrated system rather than four running in parallel and exhausting the same people.
How is a regulatory inspection record scored?+
Scoring is order count. High is bad. Scores exist to make the form tell you something, not to produce a percentage for its own sake.
Can the regulatory inspection record template be changed?+
Yes. Every field, option, score and conditional rule is editable, and the links to other templates come with it. Most teams install it as it is, run it for a cycle, then adjust.
The agents
What the agents do with it
The form is the easy part. Keeping it current, routing it to the right owner and holding the evidence together is the work that actually slips.
Holds the regulatory inspection record library against your registers, routes each record to its owner, and keeps the evidence trail together.
Coordinates the crew, rolls completion and exceptions into one view, and holds every write for your approval before it touches a record.
This template lives in KnowComply — audit and governance. Audit programmes, legal register, management review, risk and certification.
Sources
Sources
- Regulatory practice — Regulatory practice