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Software and CQC, what is actually being assessed

By the wai teamOctober 13, 20268 min read

Reviewed by The Wellness Clinical Team, October 5, 2026

Summary

No software is CQC registered and none can be. The Care Quality Commission registers providers of regulated activities, so the clinic holds the registration and the duty, and software is only ever evidence that the duty was met. That distinction decides what to look for. Four of the fundamental standards in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 are answered largely from systems rather than from paper. Regulation 12 on safe care and treatment, Regulation 17 on good governance and the records within it, Regulation 18 on staffing, and Regulation 19 on fit and proper persons employed. A vendor claiming its product is CQC compliant is describing something that does not exist.

Buyers ask which software is CQC compliant, and the honest answer is that the question has no object. CQC registers providers of regulated activities. It does not register, approve, certify or accredit software, and there is no register a product can appear on.

What an assessment actually does is ask a clinic to show that something happened, and most of those answers now live in systems rather than in a folder. That is the useful version of the question, and it has specific answers.

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The four fundamental standards answered mostly from systems
RegulationWhat it requiresWhat a system has to be able to show
12, safe care and treatmentCare and treatment provided in a safe way, including the proper and safe management of medicinesWhat was prescribed, by whom, against which decision, and that the person prescribing was entitled to
17, good governanceRecords that are complete, accurate and contemporaneous, kept securely, with systems to assess and monitor quality and riskWhen an entry was made rather than when it was typed up, who changed it, and what it said before they did
18, staffingSufficient numbers of suitably qualified, competent, skilled and experienced staff deployedWho was rostered, who actually worked, and what cover existed when somebody did not
19, fit and proper persons employedStaff of good character with the qualifications, competence, skills and experience necessary, evidenced before and during employmentThat a registration was checked, when it was last checked, and what happened when it lapsed

No product is CQC compliant, and a vendor saying otherwise has told you something

The Care Quality Commission registers providers who carry on regulated activities in England. A clinic treating disease, disorder or injury registers. The software that clinic uses does not, because registration attaches to the activity and the person responsible for it rather than to a tool used while doing it.

This matters commercially rather than pedantically. A supplier who claims their product is CQC compliant, approved or certified is either describing a thing that does not exist or hoping you will not check, and the same looseness tends to show up in the answers that do matter. The question worth putting instead is narrower and answerable, which is what the product can evidence when somebody asks.

Records, and the word contemporaneous

Regulation 17 requires an accurate, complete and contemporaneous record in respect of each service user. Contemporaneous is the word that decides whether a system helps or hurts, because it means the record was made at the time rather than reconstructed at the end of a clinic, and a system that cannot distinguish the two cannot evidence it.

The practical test is whether the record carries its own history. When an entry was created, who created it, what it said before it was edited and who approved the change are four separate facts, and a system that overwrites rather than versions can produce none of them. Our page on monitoring an AI scribe once it is live covers the signals that tell you a documentation system has started drifting, which is the same evidence read a different way.

Staffing, and the gap between the rota and the day

Regulation 18 asks for sufficient numbers of suitably qualified, competent, skilled and experienced persons deployed. Deployed is doing the work in that sentence, because a rota describes an intention and an assessment is interested in what happened.

Most clinics can produce the planned rota instantly and the worked reality slowly, which is the wrong way round. The question an inspector reaches is usually about a specific date, and the answer needs to survive the follow up, which is who covered when somebody did not arrive and whether that person was qualified for what they covered.

Registration checks, which lapse quietly

Regulation 19 requires staff to be of good character and to have the qualifications, competence, skills and experience necessary, and the evidence for it is not a one off. A professional registration can lapse, be suspended or carry conditions, and none of those events sends your clinic a letter.

A system that recorded the check at onboarding and never again is evidence of a check on one day rather than evidence of a duty being met. What survives a follow up question is a date of last verification per person, held somewhere that somebody looks at rather than somewhere it was filed.

The framework is changing, and the evidence is not

CQC announced in March 2026 that it is moving away from one single assessment framework towards sector specific frameworks, with four drafts covering adult social care, mental health, primary care and community services, and hospitals. Key lines of enquiry replace the quality statements, each key question carrying between three and seven of them, and rating characteristics replace the scoring model. The consultation closed in June 2026 and the frameworks went to piloting over the summer.

The five key questions are unchanged. Safe, effective, caring, responsive and well led survive every version of this, and so does the underlying legislation, because the fundamental standards sit in regulations rather than in the assessment method. A clinic choosing systems on the current framework's vocabulary is buying against something that is being rewritten. A clinic choosing them on what the regulations require is not.

Where a given independent clinic lands across those four sector frameworks is not obvious from the outside, and anybody telling you with certainty which one applies to you is guessing. The regulations are the part worth building against.

What we are not claiming

This page describes what the regulations require and what systems can evidence. It is not legal advice, it is not a compliance assessment, and it does not substitute for your registered manager's own judgement or for the guidance CQC publishes itself. Where a decision turns on detail, the legislation linked below governs rather than this summary of it.

wai is not CQC registered, cannot be, and makes no claim to be. We are software used by registered providers. The registration and the duty stay with the clinic.

Where wai sits

wai is built so a clinician makes every clinical decision. It drafts the note, the letters and the coding for review, shows its working so a reviewer checks reasoning rather than trusting output, and holds every patient-affecting action for approval. Every read of a patient record is logged against a named role.

The reason that design helps here is incidental to why it exists. A system where a person approved each thing, and the approval is on the record next to the draft and the edits, answers the evidence questions above as a report rather than as a reconstruction. That is a side effect of building for a clinician rather than a feature built for an inspector.

Request our answers to every question on this page in writing before the demo. A supplier who will not put them in writing early, including us, has told you where they are. Clinicians still decide what enters the record.

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Frequently asked questions

Is any software CQC compliant or CQC approved?

No. CQC registers providers who carry on regulated activities, not software. There is no register, approval or certification a product can hold, so a supplier claiming to be CQC compliant is describing something that does not exist. The useful question is what the product can evidence when an assessor asks.

Which regulations does a clinic's software actually touch?

Mainly four of the fundamental standards in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Regulation 12 on safe care and treatment including medicines, Regulation 17 on good governance and records, Regulation 18 on staffing, and Regulation 19 on fit and proper persons employed.

What does contemporaneous mean for a clinical record?

That the record was made at the time rather than written up afterwards. A system evidences it by carrying its own history, which is when an entry was created, by whom, what it said before any edit and who approved the change. A system that overwrites rather than versions cannot show any of that.

Has the CQC assessment framework changed in 2026?

Yes. CQC set out in March 2026 a move from one single assessment framework to sector specific frameworks, with key lines of enquiry replacing quality statements and rating characteristics replacing the scoring model. The consultation closed in June 2026 and piloting followed. The five key questions and the underlying regulations are unchanged.

Is wai CQC registered?

No, and it could not be. CQC registers providers of regulated activities rather than software suppliers. The clinic holds the registration and the duty. wai is a system a registered provider uses, and what it offers is evidence that the duty was met rather than any status of its own.

What is the difference between a rota and evidence of staffing?

A rota records an intention. Regulation 18 asks about deployment, which is what happened. Evidence that survives a follow up question covers who was planned, who actually worked, who covered a gap and whether that person was qualified for what they covered on the specific date being asked about.

Sources

  1. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
  2. CQC, our March 2026 update on sector based assessment frameworks
  3. CQC, assessing quality and performance

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