Start with the decision in front of you
Ask about a return, qualification check, deviation, recall, delegation or inspection action in the context of the organisation and activity concerned.
RESPONSIBLE PERSON SUPPORT
Support for the RP.
Accountability stays human.
ANDY supports pharmaceutical Responsible Persons with cited regulatory evidence, controlled company procedures and reviewable working analysis—without presenting software as the statutory role or decision-maker.
BUILT AROUND ACCOUNTABLE REVIEW
Help the RP reach and preserve a better-informed decision.
Bring the relevant evidence together
Work from published requirements, controlled SOPs and the documents attached to the assessment. Each source remains identifiable so regulatory expectation is not confused with company procedure.
Expose the judgement boundary
ANDY surfaces missing facts, source conflicts and points that require the RP’s knowledge of the operation instead of manufacturing a definitive answer from incomplete evidence.
Keep the rationale with the work
Preserve the question, evidence and review trail so the person accountable can challenge the analysis and record what was decided outside the AI output.
RP responsibilities Delegated duties Cited answers Decision boundaries Review trails Human accountability
Keep recurring GDP responsibilities visible.
Work across supplier and customer approval, self-inspection, training, outsourced activity, recalls, returns and other responsibilities named in GDP Chapter 2.
Give review context to work performed by others.
Bring the task, evidence and recorded rationale together so delegation supports oversight without implying that accountability moved with the task.
Separate evidence from recommendation.
See which claims are supported, what remains uncertain and which points require product, site or organisational knowledge before the RP decides.
Keep knowledge attached to the organisation.
Use controlled procedures and recorded collaboration to reduce dependence on scattered email threads or a single person’s memory while preserving role-aware access.
ANDY is not the Responsible Person
ANDY cannot be named on a WDA(H), exercise professional judgement, accept delegated accountability, approve trading partners or make regulated stock decisions. It is software designed to support the people who hold those responsibilities.
QUESTIONS, ANSWERED
Clear about the boundary.
No. A WDA(H) holder must have the services of a suitably qualified human Responsible Person. ANDY is decision-support software and cannot hold the role or its accountability.
ANDY is not a consultancy and does not provide a named RP service. It can support internal or contract RPs by organising evidence, controlled knowledge and reviewable working analysis.
Each organisation’s evidence and controlled knowledge must remain appropriately separated. Workspace structure and access controls can support that separation, while the contractual and regulatory suitability of the RP arrangement remains outside the software.
No. It can help structure and review the evidence generated by delegated work, but approval, oversight and accountability stay with the authorised human process.
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.
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