New
AI Compliance Assistant — cited answers from your own SOPs
The AI Compliance Assistant is a chat assistant grounded exclusively in your organisation's own SOPs, quality documents and guidance. Staff ask in plain language; it answers with the exact clause — and escalates to a named human when it shouldn't answer.
Sample questions — click to try:
QA stops being the human search engine
Every routine "which SOP covers…?" question your quality team answers is time taken from investigations, reviews and improvement. The assistant answers the routine; your experts keep the judgement.
The working day today
- Staff interrupt QA with the same procedural questions, dozens of times a week
- Answers vary depending on who you ask — and which printout they remember
- New starters wait for someone senior to be free before they can proceed
- People work from memory or superseded versions when answers are slow
- Inspection document requests trigger a hunt across folders while the inspector waits
With this solution
- Staff self-serve answers cited to the exact clause of the effective version
- One consistent source of truth — the same question gets the same cited answer
- New starters resolve most questions themselves from day one
- Every answer reflects the current effective document, never a stale copy
- Any controlled document retrieved in seconds, with the request logged
What that means in productivity, time and money
The assistant is measured on questions deflected, answer accuracy and retrieval speed — baselined in your pilot.
Each deflected question is QA time returned to investigations, CAPA quality and audit preparation. Example: a site QA team fielding 15–20 procedural questions a day gets the equivalent of a part-time role back — without hiring.
Staff no longer queue behind a busy QA inbox: answers arrive in seconds, cited for verification. During inspections, document retrieval that took minutes to hours happens while the inspector is still finishing the question.
A single deviation caused by someone working from memory can cost days of investigation and CAPA effort — more if an inspector finds it first. Consistent, cited answers cut that error class at the source, and reduce the QA overhead absorbed by every project.
Figures are indicative of typical industry workloads. Your pilot establishes your actual baseline and measured return before any rollout decision.
Answers your teams can act on — and auditors can trace
Not a general chatbot. A retrieval-grounded assistant that only speaks from your controlled documents.
Cited to the clause
Every answer links to the exact SOP section and version it came from, so staff can verify in one click.
Grounded, not guessing
The assistant answers only from your approved document set. If the answer isn't there, it says so — no invented guidance.
Human escalation
Uncertain or high-risk questions route automatically to a named QA or PV contact, with the full context attached.
Complete audit log
Every question, answer, source and escalation is recorded and attributable — inspection-ready by default.
Always current
Connected to your document management system, so answers reflect the effective version — never a superseded one.
Inspection mode
Retrieve any controlled document, training record or past deviation in seconds while the inspector waits.
One assistant, four teams it helps every day
Stop being the human search engine
- Deflect routine "which SOP covers…?" questions
- Flag conflicting or outdated procedures
- Faster deviation and CAPA look-ups
Consistent answers on safety process
- Reporting timelines and seriousness criteria at hand
- Reconciliation and submission procedure queries
- Onboard new case processors faster
GCP guidance without the wait
- Protocol, consent and TMF procedure questions
- Site staff self-serve instead of emailing the CTM
- Consistent answers across every site and region
Answers on the floor, not in a binder
- Line clearance, cleaning and batch record queries
- Reduce errors from working off memory
- Shift handover knowledge that doesn't get lost
From your document set to a live assistant in 6–10 weeks
Connect your documents
We index your approved SOPs, policies and guidance from your DMS — read-only, with your access controls respected.
Configure & ground
Scope, tone, escalation rules and restricted topics are defined with your QA team — the assistant only answers within them.
Validate
Delivered with a GAMP 5 validation package: requirements, risk assessment, test scripts and traceability matrix.
Launch & monitor
Go-live with staff training and an SOP for AI use. We monitor accuracy and review performance with you quarterly.
Built the way your inspectors expect systems to be built
Whitehall has taught GxP compliance for over two decades. That thinking is in every design decision.
GAMP 5 (2nd Ed.)
Full validation documentation, including AI/ML-specific controls and periodic review.
Human-in-the-loop
The assistant informs; qualified people decide. High-risk queries always reach a human.
ALCOA+ audit trails
Attributable, legible, contemporaneous records of every interaction and configuration change.
GDPR & data residency
Your documents stay in your approved region. No training on your data. Role-based access throughout.
Questions compliance teams ask us first
What happens if the assistant doesn't know the answer?
It says so, and offers to escalate. The assistant is configured to answer only from your approved documents — if the information isn't there, it will never improvise. Escalated questions go to a named contact with the full conversation attached, and become a signal that an SOP may need clarifying.
Is our data used to train AI models?
No. Your documents are used only to retrieve and ground answers for your organisation. They are not used to train any model, and they remain within your approved hosting region under your access controls.
How is this validated for use in a GxP environment?
Each deployment ships with a GAMP 5 (Second Edition) validation package: user requirements, functional risk assessment, test evidence, traceability matrix and a periodic review plan. We also help you write the SOP governing its use.
What if an SOP is updated or superseded?
The assistant connects to your document management system and answers only from effective versions. When a document is superseded, the change is reflected automatically and logged.
How long does implementation take?
A typical deployment takes 6–10 weeks from kick-off to validated go-live, depending on the size of your document set and your validation requirements. We usually start with one department (most often QA) and expand from there.
See it answer questions from your own SOPs
Bring three procedures to a 30-minute demo and watch the assistant answer from them — citations, escalation and audit log included.
Enquire NowNo obligation · NDA available · delivered by consultants who know your regulations