RegOpsPro™

GDP Source Basis

RegOpsPro tools and AI support are built around recognised GDP control themes: accountable roles, documented systems, evidence, supplier oversight, storage and transport control, traceability, recall readiness, deviations, CAPA and governance.

View Methodology

Source basis approach

The platform does not quote regulations line-by-line or provide legal advice. It translates stable GDP expectation themes into practical operating-model steps, tool inputs, qualified outputs and GDP-grounded AI prompt controls.

EU GDP expectations inform the distribution-control structure.
MHRA GDP expectations inform UK RP, WDA(H), inspection and governance framing.
QMS-transfer wording keeps formal approval and controlled QMS records within the user's own system.
AI support is mapped to GDP control themes but does not make decisions or claim compliance.

GDP interpretation matrix

Theme	RegOps interpretation	Used in platform	AI prompt rule
RP accountability	RP decisions should be structured, evidenced and defensible.	RP workspace, Event Triage, RP Decision Builder	Draft wording only; do not make final RP decisions.
Quality system and documentation	Outputs should support controlled QMS transfer, not replace QMS records.	All tools, governance packs, AI outputs	Include QMS-transfer caution and evidence checks.
Product integrity and patient safety	Events should consider potential product quality, suitability and patient-risk implications.	Event Triage, RP Decision Builder, CAPA	Flag uncertainty and evidence required; do not decide final product status.
Supplier oversight	Supplier and 3PL risks should be visible, reviewed and escalated when needed.	Supplier scorecard, CAPA, governance packs	Highlight evidence gaps and avoid inventing audit/QTA facts.
Receipt and import status control	Product movement and import handling depend on evidence, status and escalation control.	RP-I receipt, discrepancy, evidence and governance tools	Never imply release, acceptance or final disposition.
Traceability and recall readiness	Batch, customer, location and status evidence should be retrievable and explainable.	Recall simulation, tracker, decision checklist, inspection pack	Convert facts into narrative; do not invent evidence.
Deviation and CAPA	Problems should be contained, investigated, corrected and effectiveness-checked.	CAPA Builder, risk tools, governance packs	Do not imply root cause, closure or effectiveness is proven unless supplied.
Inspection readiness	Evidence should be accessible, mapped, owned and supported by a clear narrative.	Readiness scorecard, Evidence Index, Inspection Pack, AI Drafting Hub	Flag missing evidence, likely questions and challenge points.
Governance	Risks, trends and open actions require management visibility.	Operational, Board and RP-I governance packs	Draft concise governance wording from supplied facts.

Primary regulatory sources

RegOpsPro content is periodically checked against primary sources. Users should confirm the current version and applicability to their licence, territory, product and activity.

GDP-grounded AI: RegOpsPro AI uses controlled prompt logic mapped to these themes. AI outputs are designed to show GDP control themes applied, evidence gaps / uncertainty and QMS-transfer caution. This is not legal advice, compliance certification or AI decision-making.

Important: users remain responsible for confirming applicable legal, regulatory and QMS requirements. RegOpsPro tools support practical execution and preparation; they do not replace formal regulatory advice or controlled quality-system processes.