Evidence gets detached from conclusions.
Attachments pile up while assumptions, missing checks and unresolved impact questions disappear into narrative text.
For QA Leaders, QPs, Investigators and SOP Owners
Quality investigations with AI controls built in.
Verrion Systems builds controlled software for GMP quality teams evaluating AI support in deviation and SOP workflows. The suite helps teams assemble evidence, compare SOP expectations, surface reasoning gaps and prepare review-ready outputs while keeping sanitisation, traceability and human approval in the record.
- AI use
- Decision support, not QA approval
- Hosted pilot setup
- Customer-agreed routing and governance scope
- Primary users
- QA, QPs, Investigators, SOP Owners
Why Pharma Leaders should care
Most weak investigations do not fail because the report is ugly. They fail because the reasoning cannot be defended.
SOP expectations are consulted too late.
Procedural requirements should shape the investigation, not be searched manually after the RCA is already drafted.
AI output is hard to reconstruct.
Generic assistants can create polished wording without showing sanitisation, prompt context, model version or reviewer decision state.
Controlled workflow
A practical path from event facts to review-ready output.
Frame the quality event
Capture facts, product or batch scope, owner, due date, severity and immediate actions before analysis begins.
Anchor SOP context
Bring procedure clauses, evidence packs and open questions into the same workspace so expectations remain visible.
Apply AI with documented controls
Sanitise context, record prompt and model versions, keep suggestions editable and keep the quality decision with authorised reviewers.
Review and export
Flag AI-assisted text, preserve accept/edit/reject decisions and export a review pack with evidence links and audit history.
AI control record
When AI supports regulated quality work, reviewers need evidence they can inspect: what context was used, how identifiers were protected, which suggestion was made, and who accepted, edited or rejected it.
Make the governance visible in the work, not hidden in a policy document.
Control
Pharma review question
Verrion Systems posture
Sanitisation
What leaves the customer context?
People, batch, supplier, site and internal identifiers are reviewed and replaced before AI support.
Traceability
Can we reconstruct what shaped the suggestion?
Prompt version, model version, source context and reviewer action are retained in the record.
Human oversight
Who made the quality judgement?
AI remains decision support. Authorised users accept, edit or reject suggestions before output.
Report transparency
Will reviewers see AI-assisted text?
AI-assisted report content is visibly flagged so reviewers can challenge, approve or remove it.
Pilot boundary
Is this a validated production claim?
Private pilots evaluate workflow fit and validation readiness. Customers validate any intended GxP use.
Suite modules
Two connected workflows, one evidence discipline.
Deviation Investigator
A controlled workspace for event facts, evidence packs, SOP expectations, impact questions, RCA/CAPA reasoning, reviewer comments and exportable investigation output.
- Evidence gaps surfaced before approval
- RCA and CAPA rationale tied back to failed controls
- AI-assisted content flagged in reports
SOP Intelligence
A procedure intelligence layer for interrogating SOP content, extracting clause-linked expectations and comparing them with live investigation context.
- Clause-linked procedural expectations
- Ambiguity and control gaps for human review
- Procedure-update prompts where controls appear weak
Private pilot
A narrow pilot for serious quality and AI governance conversations.
The right first conversation is not a vague demo or a generic AI promise. It is a controlled pilot using synthetic or customer-approved scenarios, a small QA user group and clear criteria for workflow fit, report quality, data handling and validation-readiness review.
Typical four-week scope
- One to two synthetic or approved deviation and SOP scenarios
- Guided onboarding for QA, investigator or SOP owner users
- Hosted pilot with sanitisation-first AI workflow
- End-of-pilot review covering workflow fit, AI governance and export/deletion path
Next step
See how controlled AI support fits regulated quality work.
Book a private walkthrough of Verrion Systems Deviation Investigator, SOP Intelligence and the AI governance record behind each suggestion.