Frame the quality task
Distinguish a quick regulatory question from deviation support, SOP comparison, inspection preparation or a decision-sensitive assessment before generating working material.
PHARMACEUTICAL QUALITY AI
Quality work moves faster
when evidence stays visible.
ANDY gives pharmaceutical quality teams an AI workspace for source-linked analysis across GDP guidance, controlled procedures and working documents—designed to complement established quality systems and human approval.
AN INTELLIGENCE LAYER FOR QUALITY WORK
Connect the question, source and review path.
Search governed knowledge
Use approved regulatory sources, role-visible controlled procedures and task-specific attachments while keeping each evidence type clearly identified.
Challenge the analysis
Inspect citations, surface uncertainty and involve colleagues in a recorded review rather than treating a fluent first answer as the end of the quality process.
Move into the system of record
Export supported working material for your established deviation, CAPA, document-control or audit workflow without representing the AI workspace as final approval.
Quality intelligence Controlled knowledge Deviation support SOP analysis Cited drafts QMS companion
Add analysis without replacing controlled workflows.
Use ANDY beside systems that own documents, training, deviations and CAPAs, focusing the AI workspace on evidence retrieval, comparison and reviewable drafting.
Make the basis of each answer inspectable.
Connect material claims to regulatory excerpts, controlled procedures or supplied records so quality reviewers can verify the support themselves.
Keep discussion attached to the assessment.
Share recorded conversations and working drafts with the people who own the process, product or technical decision instead of losing rationale across separate messages.
Keep generated material inside an explicit boundary.
Separate AI-assisted working content from approved records, preserve human review and avoid implying that software has certified compliance or completed technical investigation.
An intelligence layer—not a replacement quality system
ANDY does not replace document control, training records, deviation ownership, CAPA approval, audit programmes or validated systems required by your operation. It supports evidence-led analysis and drafting around those controlled processes.
QUESTIONS, ANSWERED
Clear about the boundary.
ANDY is an AI evidence and collaboration workspace, not a claim to replace every eQMS function. It can complement systems that remain responsible for controlled records and formal quality workflows.
Yes. Eligible plans include a controlled SOP library with version, lifecycle and visibility controls, while task-specific documents can be attached to a focused conversation.
No. It can support evidence review, investigation structure and working drafts. Process owners and authorised reviewers remain responsible for conclusions, actions, effectiveness checks and closure.
Generated material remains working content with visible sources and review boundaries. It is not automatically promoted into an approved procedure, quality record or regulatory response.
READY WHEN YOU ARE
Put ANDY
beside your RP.
Start with a focused workspace for day-to-day compliance work, then bring your team and controlled knowledge with you.
View plans