Robosol Addons tailored for GxP Compliance

Pharmaceutical and life sciences companies in the UK must demonstrate to the MHRA that every computerised system used in a regulated activity is correctly installed, validated and fit for purpose. Microsoft Dynamics 365 Business Central provides the operational foundation — but meeting GxP compliance requirements demands additional controls beyond the standard platform. Robosol has built five dedicated Dynamics 365 GxP addons that bring batch controls, licence enforcement and quota management directly into your ERP, supported by a structured IQ OQ PQ validation service for UK pharmaceutical businesses.

What Is GxP Compliance in Microsoft Dynamics 365?

GxP covers Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Laboratory Practice (GLP) — the quality standards that govern pharmaceutical production, storage and distribution in the UK. In a Business Central environment, this regulatory framework means the software must support auditable records, controlled batch processing, data integrity, access restrictions and full traceability from raw material receipt through to finished product dispatch. No ERP platform achieves this straight from installation. Regulatory readiness depends on validated configuration, formal qualification testing and purpose-built addons that enforce controls where standard functionality falls short. For UK businesses, the MHRA assesses computer system validation during Good Practice inspections — expecting documented evidence that the system performs as intended, is used as designed and sits within a controlled change management process.

Robosol’s Dynamics 365 GxP addons address the specific gaps between standard Business Central and full MHRA audit readiness — supporting licensed wholesale distributors, unlicensed medicine importers and regulated pharmaceutical manufacturers across the UK.

Dynamics 365 GxP Compliance Addons for UK Pharmaceutical Businesses

Developed by Robosol’s technical team in alignment with GAMP 5 and EU GMP Annex 11, these five addons extend the platform with the specific controls that pharmaceutical operations need for GxP qualification and regulatory inspection readiness.

Company License Management​

Controlled drug distribution in the UK requires every sale and purchase to involve a party holding a current, valid pharmaceutical licence. This addon maintains a central licence record for every supplier and customer in the system — covering licence type, issue date and expiry. Orders cannot be posted where a licence is absent, expired or outside its approved scope. The system enforces this as a hard block rather than a warning, giving your qualified person the audit evidence required during regulatory inspections without reliance on manual checks outside the ERP.

Status Management by Batch

Batch integrity is a core requirement of both GMP and GDP in UK pharmaceutical operations. This addon introduces a configurable batch status framework inside Business Central, enabling warehouse staff to assign and update the status of any batch — quarantine, released, rejected or under QP review — at any storage location. No batch can progress to picking, dispatch or further processing while a clearance is outstanding. Every status change is date-stamped and user-attributed, creating a tamper-evident audit trail that satisfies inspection requirements and supports batch release documentation for your quality team.

Capacity/Quota Planning

Third-party sales of controlled and quota-restricted medicines require strict quantity management that standard Business Central order processing cannot enforce independently. This addon monitors live inventory against approved sales quotas, applying automatic quantity limits to open orders and back-order positions simultaneously. Your distribution team can track quota consumption across all active sales channels in real time — removing the compliance risk that arises when quota management relies on spreadsheets or processes outside the ERP system.

Product License Management

Where the Capacity/Quota Planning addon governs quantity thresholds, this addon controls which products each trading partner is authorised to receive. Every customer record in the ERP is linked to an approved product list, and each order line is validated against that list automatically at the point of entry. Any attempt to dispatch a product outside the customer's licensed scope triggers an immediate system block — producing a documented, system-generated validation record that can be presented as evidence during regulatory audits of licensed pharmaceutical wholesale operations.

Pharma Manufacturing - Component Reconciliation

Pharmaceutical production tolerances mean component consumption rarely matches bill-of-material quantities precisely. This addon allows production orders in the platform to accommodate over-picking within pre-defined tolerance thresholds. On job completion, any surplus material is automatically returned to stock with a system-recorded movement, and the full component reconciliation is captured against the production batch record. The resulting data trail supports batch release sign-off, annual product reviews and regulatory manufacturing inspections — replacing manual reconciliation outside the ERP with an auditable, in-system process.

Why UK Pharmaceutical Businesses Choose Robosol

Robosol is a Microsoft Gold Partner with over fifteen years of experience implementing Dynamics 365 for regulated pharmaceutical businesses across the UK. Our clients span licensed wholesale distribution, unlicensed medicine imports and regulated primary and secondary manufacturing — environments where system failures carry direct regulatory consequences.

Unlike generalist Business Central partners, Robosol brings proprietary GxP addons and in-house validation expertise under one roof. Clients receive a single-supplier engagement that covers technical implementation, compliance configuration and qualification documentation — with no need to coordinate a separate validation consultant alongside the ERP project. We understand what MHRA inspectors look for and we build that evidence into the delivery from day one.

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IQ OQ PQ Validation Software for UK Pharmaceutical Companies

Under EU GMP Annex 11 and GAMP 5, the MHRA requires formal validation of any computerised system used in a GxP-regulated environment. Robosol delivers a structured IQ OQ PQ validation service alongside every Dynamics 365 implementation for UK pharmaceutical clients — covering all three qualification phases and producing the complete documentation set your QA team needs.

Installation Qualification (IQ)

Confirms that Dynamics 365 Business Central has been installed to the agreed specification. Infrastructure, network settings, user roles and all Robosol GxP addons are tested against defined criteria and formally approved before operational testing begins.

Operational Qualification (OQ)

Verifies that the system performs correctly under normal business conditions. Test scripts cover licence management, batch status workflows, quota enforcement, financial processing and reporting — demonstrating that each function meets its documented specification in a controlled test environment.

Performance Qualification (PQ)

PQ testing confirms consistent system performance with live users and real data before go-live, producing the Validation Summary Report your MHRA inspectors require. Robosol delivers the complete package — IQ, OQ and PQ protocols, signed test records and the finished report — so your QA team receives an inspection-ready file, not a blank template.