Robosol Addons tailored for GxP Compliance

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

What Is GxP Compliance in Microsoft Dynamics 365?

GxP covers Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Laboratory Practice (GLP). These are 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 and data integrity. It must also enforce access restrictions and full traceability from raw material receipt through to finished product dispatch. However, no ERP platform achieves this straight from installation. Furthermore, 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. In particular, inspectors expect documented evidence that the system performs as intended, functions as designed and operates within a controlled change management process.

As a result, our 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 in alignment with GAMP 5 and EU GMP Annex 11, these five addons extend the platform with controls that pharmaceutical operations need. In particular, each one is built for Good Practice qualification and regulatory inspection readiness.

Company License Management​

Specifically, controlled drug distribution in the UK requires every sale and purchase to involve a party holding a current, valid pharmaceutical licence. The Company Licence 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. As a result, your qualified person receives the audit evidence required during regulatory inspections — with no reliance on manual checks outside Business Central.

Status Management by Batch

Similarly, batch integrity is a core requirement of both GMP and GDP in UK pharmaceutical operations. The Status Management addon introduces a configurable batch status framework within Business Central. Meanwhile, warehouse staff can assign and update batch status — quarantine, released, rejected or under QP review — at any storage location. Therefore, no batch can progress to picking, dispatch or further processing while a clearance is outstanding. The system date-stamps and attributes every status change to the responsible user, creating a tamper-evident audit trail. This satisfies inspection requirements and supports batch release documentation for your quality team.

Quota, Licence and Manufacturing Controls

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. This removes the compliance risk that arises when quota management relies on spreadsheets or processes outside the ERP.

Product License Management

Where the Capacity/Quota Planning addon governs quantity thresholds, this addon controls which products each trading partner is authorised to receive. Accordingly, the ERP links every customer record to an approved product list and validates each order line against it automatically at the point of entry. Any attempt to dispatch a product outside the customer's licensed scope triggers an immediate system block. This produces a documented, system-generated validation record for use as evidence during regulatory audits of licensed pharmaceutical wholesale operations.

Pharma Manufacturing - Component Reconciliation

In practice, 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, the system automatically returns any surplus material to stock with a system-recorded movement. The full component reconciliation is then captured against the production batch record. Consequently, the resulting data trail supports batch release sign-off, annual product reviews and regulatory manufacturing inspections. This replaces manual reconciliation outside the system with an auditable, in-system process.

Why UK Pharmaceutical Businesses Choose Robosol

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

Robosol has delivered Dynamics 365 GxP compliance implementations for UK pharmaceutical manufacturers and licensed wholesalers. Our IQ OQ PQ validation service follows GAMP 5 and EU GMP Annex 11 — giving your QA team audit-ready documentation for MHRA inspection.

One Partner for Implementation and Validation

Unlike generalist Business Central partners, our team brings proprietary compliance addons and in-house validation expertise under one roof. Clients receive a single-supplier engagement covering technical implementation, compliance configuration and qualification documentation. There is 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.

Talk to our team to find out how we can support your next GxP compliance project.

Written by the Robosol Dynamics 365 Team — Microsoft Gold Partner since 2010.

Book a Free Demo

IQ OQ PQ Validation Software for UK Pharmaceutical Companies

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

Installation Qualification (IQ)

Confirms that Dynamics 365 Business Central has been installed to the agreed specification. Robosol tests infrastructure, network settings, user roles and all compliance addons against defined criteria and formally approves each 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 and reporting. Each test demonstrates that the 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 VSR document. Ultimately, your QA team receives an inspection-ready file, not a blank template.