Start from the controlled version
Publish an approved version to the organisation’s SOP library or attach a document for a focused assessment. ANDY keeps controlled knowledge separate from temporary conversation evidence.
PHARMACEUTICAL SOP AI
Your SOPs.
Inside the answer.
ANDY helps pharmaceutical quality teams compare procedures with GDP requirements, interrogate controlled versions and prepare source-linked working drafts without confusing generated content with approved documentation.
FROM CONTROLLED PROCEDURE TO REVIEWABLE WORK
Compare the procedure, not just the wording.
Ask a specific comparison question
Review a procedure against a GDP topic, investigate a known gap or ask where responsibilities, evidence and escalation points are unclear. The task stays narrower than a generic document rewrite.
Inspect claims beside their sources
Open cited excerpts, distinguish regulatory requirements from company procedure and challenge weak or stale evidence before carrying any proposed change forward.
Create a working draft for human control
Turn supported analysis into structured working material while keeping it visibly separate from approved documents, formal change control and the people authorised to approve a new version.
SOP comparison Controlled versions GDP gap analysis Source excerpts Working drafts Human approval
Ask against the procedure your team actually uses.
Controlled versions carry lifecycle and visibility context so teams can reason from the relevant procedure rather than an unidentified file found in a shared folder.
See why a gap was identified.
Keep each material observation connected to the regulatory or procedural excerpt behind it, making the comparison easier to challenge and review.
Treat missing context as part of the assessment.
ANDY can surface absent responsibilities, conflicting evidence and questions that need process-owner or RP input rather than filling the space with invented certainty.
Move analysis forward without bypassing approval.
Export reviewable working drafts that can enter your established authoring, change-control and approval process without being mistaken for an effective SOP.
A working draft is not an approved SOP
ANDY can support comparison, analysis and drafting, but it does not approve controlled documents, replace your document-management controls or decide whether a procedure is effective. Formal ownership, review, change control, training and approval remain with your quality system.
QUESTIONS, ANSWERED
Clear about the boundary.
Yes. ANDY can analyse an attached procedure or controlled SOP version against relevant evidence, present cited observations and identify questions that still need human judgement.
No. It can prepare source-linked working material, but approval, effective dates, training impact and formal change control remain in your established quality process.
The workspace labels and cites organisation-controlled knowledge separately from regulatory sources and conversation attachments, so reviewers can see what kind of evidence supports each claim.
The SOP library supports role-aware and team-aware visibility controls. The exact capacity available to a workspace is shown in ANDY’s live plan catalogue.
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