Compliant pharma manufacturing, end to end. Powered by COSMO ERP Pharma Manufacturing.

Compliant pharma manufacturing, end to end. Powered by COSMO ERP Pharma Manufacturing.

Digitize your pharma processes with batch management, integrated quality inspection, and CAPA workflows built on Microsoft Dynamics 365 Business Central.

ERP for Pharma Manufacturing: flexible production, End-to-End compliance, and validation confidence

COSMO ERP Pharma Manufacturing extends Microsoft Dynamics 365 Business Central with purpose-built capabilities for the pharmaceutical industry. It brings together complex manufacturing processes, mixed production methods, and all critical regulatory requirements in a single ERP platform. End-to-end batch and container management, quality assurance, inspection workflows, quality management, vendor rating, and digital approvals are all fully integrated. The result: maximum transparency, process reliability, and validation confidence, all within the familiar Microsoft environment. 

With COSMO ERP Pharma Manufacturing, you get GMP-compliant processes, audit-ready trails, and complete traceability. Reduce audit effort, accelerate approvals, and stay compliant with EU-GMP, GDP, and FDA standards. 

Integrated Formula and Batch Management with Built-In Quality Assurance

COSMO ERP Pharma Manufacturing unifies formula management, quality inspection, quality status, and batch management in a single end-to-end ERP solution for the pharmaceutical industry, increasing transparency, compliance, and efficiency across your entire value chain. 

Integrated formula management supports precise active ingredient calculations, complex variant management, and consistent product quality. Automated workflows handle approvals, deviations, and CAPA processes, delivering real-time status updates for faster, better-informed decisions. Audit-ready trails document every critical change with full traceability, enabling rapid and reliable root cause analysis when quality deviations occur. 

With COSMO ERP Pharma Manufacturing, you reliably meet regulatory requirements such as GMP while improving product quality and operational efficiency at the same time. 

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How COSMO ERP Pharma Manufacturing tackles your toughest challenges

Your challenge
Product solution
Your challenge
Strict regulatory requirements, including GMP, FDA, and EU regulations, demand airtight compliance and complete audit trails.
Product solution
Compliance by Design: full digital support for GMP, FDA, and EU regulations, including audit trails and electronic signatures, so you meet regulatory requirements with confidence.
Your challenge
High risk of product recalls and quality deviations.
Product solution
End-to-end batch management and quality assurance from raw material to finished product: full batch traceability across all production stages, including serial numbers, quality status, and expiration dates, maximizes product safety and builds customer trust.
Your challenge
Disconnected ERP and quality management systems create gaps between quality management, documentation, and actual processes.
Product solution
Integrated quality management within the ERP: digital inspection plans and electronic approvals are built directly into the ERP. CAPA, audit, and deviation processes are triggered and accelerated from ERP events via a connector to your quality management system (QMS).
Your challenge
Complex formulas and approval workflows slow down operations and increase the risk of errors and waste.
Product solution
Integrated formula management: digital formula management reduces complexity through automated versioning, precise active ingredient calculations, and structured approval workflows, improving safety and minimizing waste.
Your challenge
Unclear qualification assignments in production make compliance harder to maintain and increase the risk of process deviations.
Product solution
Qualification management with integrated production scheduling: matching employee qualifications to the requirements of production processes and resources (machines and equipment) enables precise scheduling and process reliability.
Your challenge
High validation effort for system changes and new processes ties up resources and delays projects.
Product solution
Ready-to-Start validation: pre-built, field-tested validation templates, digital content, automated documentation, and test reports significantly reduce the time, cost, and effort required for validation.
Your challenge
No reliable way to objectively evaluate supplier performance.
Product solution
Integrated vendor rating: supplier performance is assessed using a combination of quantitative and qualitative criteria and stored historically in the ERP, enabling informed decisions and stable supply chains.
Your challenge
Lack of process integration for mixed production methods makes it impossible to map complex pharma manufacturing workflows in a single system.
Product solution
Hybrid manufacturing support: mixed production methods, including process manufacturing and discrete manufacturing, can be mapped in a single ERP system built on Microsoft Dynamics 365 Business Central.

Built for Compliance: Seamless Integration Between Your ERP and Quality Management Platform

COSMO ERP Pharma Manufacturing integrates seamlessly with the COSMO M365 Quality Management platform, creating connected processes across production, quality assurance, and quality management. CAPA, deviation, and change control workflows are triggered via a standardized connector in the quality management system (QMS), where they can be processed and their status fed back directly into the ERP. 

The result: transparent workflows, automated documentation, and a single source of truth for all regulatory-relevant processes. Audit trails and electronic signatures ensure full traceability and compliance with key regulatory requirements such as 21 CFR Part 11. This reduces validation effort while keeping your compliance posture strong, now and in the future. 

Features: what's under the hood

1.

End-to-End Batch and Container Management

Complete traceability from goods receipt through shipping and returns for fast, reliable root cause analysis.

2.

Integrated Quality Inspection and Electronic Approvals

Digital inspection plans, test equipment management, stability testing, and advanced electronic signatures, all built directly into the ERP.

3.

Standardized QMS Connector (CAPA, Deviations, Change Control)

Automatically triggers and closes CAPA and deviation processes based on ERP events, with full two-way status sync.

4.

Configurable Audit Trail and Validation Support

Configurable audit trails at table and field level, versioned document storage, and pre-built validation processes and documentation.

5.

Comprehensive Formula Management and Active Ingredient Calculation

Variant-capable formulas including active ingredient and excipient calculations with full specification data.

6.

Qualification Management in Production Planning

Matches employee qualifications to production processes and resources (machines and equipment) and incorporates them into detailed scheduling.

7.

Product Data and Artwork Revisions

Centralized management of product data, artwork, packaging data, and label templates with versioning and pre-built integration for labeling software such as NiceLabel.

Take a look - here's how the system works in practice

Enlarge Image
Approval workflows in pharma manufacturing with Microsoft Dynamics 365 Business Central
Streamlined approval workflows in pharma manufacturing with Microsoft Dynamics 365 Business Central

Streamlined approval workflows in pharma manufacturing with Microsoft Dynamics 365 Business Central

Fully integrated with Microsoft Dynamics 365 Business Central

COSMO ERP Pharma Manufacturing is natively integrated with Microsoft Dynamics 365 Business Central. All relevant production, quality, and batch data flows into a single, centrally managed platform. No more data silos. No more system breaks. From formula management to audit trails, every process lives in one place. 

Additional solutions from the Microsoft ecosystem, including Microsoft SharePoint Online, Microsoft Teams, and the Microsoft Power Platform, can be connected with ease. A connector to the COSMO M365 Quality Management platform, along with interfaces for label printing and third-party systems, gives you the flexibility and future-readiness your operations demand. 

Leverage the familiar Microsoft environment, automated workflows, and centralized data management. R&D, procurement, sales, production, quality assurance, warehousing, and logistics all work from the same up-to-date information. The result: streamlined operations, fewer errors, and full visibility across your entire team. 

No-obligation consultation

COSMO CONSULT: your partner for a proven pharma ERP implementation

A successful pharma ERP project demands deep industry expertise and real-world experience. COSMO CONSULT is Microsoft's #1 digitalization partner, with a proven track record of ERP implementations in the pharmaceutical industry. Built on pre-configured standard processes, our implementations are fast, focused, and backed by industry-specific best practices developed across hundreds of projects. 

Our experts ensure your processes are mapped accurately and your team is up and running quickly. We support you through Computer System Validation (CSV), data migration, and integration with your existing Microsoft environment, as well as training and ongoing support. The result is a reliable solution that delivers compliance, efficiency, and long-term scalability. 

No-obligation consultation

Recent Awards

6x Microsoft Solutions Partner
Awarded Microsoft’s highest quality seal in all categories.

6x Microsoft Solutions Partner

Awarded Microsoft’s highest quality seal in all categories.

Ranked among the top 1% of Microsoft partners worldwide every year since 2014.

Microsoft Dynamics Inner Circle

Ranked among the top 1% of Microsoft partners worldwide every year since 2014.

Among the top 0.4% of all employers in Germany.

Top-Arbeitgeber

Among the top 0.4% of all employers in Germany.

Leading data and analytics partner: 11× Leader, multiple #1 rankings, and a 100% recommendation rate.

BARC-Studie 2026

Leading data and analytics partner: 11× Leader, multiple #1 rankings, and a 100% recommendation rate.

Trusted by leading organizations

Building blocks for your complete End-to-End solution

Frequently asked questions

Your expert for COSMO ERP Pharma Manufacturing

Andy Buchmann is Industry Strategy Lead and Industry Lead for Medical Devices, BioTech, and Pharma at COSMO CONSULT. He helps companies accelerate digitalization, achieve compliance, and implement Microsoft Dynamics 365 in a validation-ready way. His focus: shortening time-to-compliance, reducing process costs, and building sustainable IT architectures. Reach out, he'd love to connect.

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COSMO ERP Pharma Manufacturing
COSMO ERP Pharma Manufacturing