Pharma Industry Software: End-to-End with Microsoft

Q: How does COSMO CONSULT pharma software support Annex 11 and 21 CFR Part 11 compliance, two of the most critical requirements in the pharmaceutical sec

COSMO CONSULT pharma software addresses both Annex 11 and 21 CFR Part 11 through digital workflows combined with electronic signatures and audit-proof audit trails.

Q: How does COSMO CONSULT pharma software reduce validation effort in the pharmaceutical industry, specifically around Computer System Validation (CSV)?

With field-tested validation templates, pre-configured processes, and clearly defined roles, your implementation is structured and efficient from day one.

Q: How does COSMO CONSULT simplify batch reviews and batch documentation for pharma companies?

Digital batch records in the ERP system consolidate all batch and test data in one central location and speed up review cycles.

Q: What integrations are available in the pharma environment, such as serialization, PLM, and labeling?

COSMO CONSULT offers open APIs and standard adapters for serialization systems, PLM/PDM, and labeling solutions.

Q: What does COSMO CONSULT offer in terms of training, support, and change management? How do you drive user adoption?

One of the key strengths of the Microsoft ecosystem is familiarity.

Q: How does COSMO CONSULT approach data security for pharma companies, and how are access rights managed in a cloud and 21 CFR Part 11 context?

COSMO CONSULT leverages the security capabilities of the world's largest software provider: Microsoft Cloud Security, role-based access controls, and electronic signatures compliant with 21 CFR Part 11.

Q: What are the benefits of integrated quality management, covering CAPAs, deviations, approvals, and document control?

Integrated quality management delivers end-to-end processes from deviation through to CAPA, with clear accountability at every step.

Q: How does COSMO CONSULT support AI-powered analytics for quality management and production planning?

AI-powered analytics enable anomaly detection, pattern recognition, and predictive scenarios that support smarter planning.

Q: What pricing and deployment models are available for pharma companies, including cloud options, contract terms, and scalability?

Flexible, scalable cloud models and modular extensibility give you full cost control. Pricing is tailored to your specific needs and actual usage, so you stay agile and can manage your IT investment with confidence.

COSMO CONSULT End-to-End solutions for the pharmaceutical industry – Efficient and compliant

Validatable, compliance-ready pharma software is the foundation for efficient, secure processes in the pharmaceutical industry. It drives clarity, confidence, and scalability for your business as it grows. With Microsoft Dynamics 365 and COSMO CONSULT solutions, you connect every part of your organization, from product development and manufacturing to quality assurance and management, through to delivery and service, in a seamless, secure end-to-end process flow.

Necessary regulatory requirements, including GxP, FDA, and GAMP 5, are fully covered. You benefit from automated audit trails, electronic signatures (21 CFR Part 11), and a centralized data foundation for all batch and quality data. The result: pharma software that helps you shorten your time-to-compliance, reduce process costs, and build a future-proof IT landscape with no ceiling on your ambitions. With COSMO CONSULT, you gain an experienced partner who supports you holistically across digitalization, validation, and compliance.

How COSMO CONSULT addresses the challenges of the pharmaceutical industry

Your challenge

Our solution

Your challenge

Regulatory Compliance & Audit Readiness Strict GxP, GAMP 5, and FDA requirements demand complete documentation, controlled processes, end-to-end audit trails, and valid electronic signatures.

Our solution

GAMP 5/Computer Software Assurance (CSA)-compliant templates: Pre-configured validation packages, audit trails, controlled processes, and electronic signatures significantly reduce validation effort and ensure audit readiness and full traceability.

Your challenge

Batch Documentation & Data Integrity Manual batch records are error-prone, slow, and make traceability and GMP-compliant data integrity difficult to achieve.

Our solution

Digital Batch Records: Digital, partially automated batch records with versioning and integrated test data accelerate release cycles and ensure high, compliance-grade data quality.

Your challenge

Disconnected Quality Management and Event Handling Deviations, CAPAs, complaints, and change controls are often managed in separate systems, leading to inefficiency, errors, and gaps in GMP compliance.

Our solution

ERP with Integrated Quality Management (QM): Deviations, complaints, and change control are initiated within the process and fully documented through workflow-driven automation. This accelerates root cause analysis and speeds up the initiation and execution of corrective quality actions.

Your challenge

Fragmented IT Landscape & System Silos MES, LIMS, scales, DMS, and ERP often operate in isolation. System silos put data consistency and GMP-compliant compliance at risk.

Our solution

Open Interfaces: Integrated pharma processes, API-based integrations, and standardized connectors link systems in a seamless end-to-end workflow, prevent data transfer errors, and ensure consistent master data.

Your challenge

Inadequate Production and Workforce Planning Equipment status, employee qualifications, and training records are often not factored into planning automatically, increasing the risk of downtime and non-compliance.

Our solution

Advanced Production Planning and Qualification-Based Workforce Scheduling: Assign staff based on the qualifications required for each piece of equipment. Advanced production planning also optimizes sequencing and capacity planning on the shop floor, preventing resource mismatches, avoiding unnecessary downtime, and enabling predictable, GMP-compliant manufacturing.

Your challenge

Scalability & Investment Protection Pharma IT systems must be scalable, secure, and validatable. At the same time, cloud updates can increase validation overhead.

Our solution

Microsoft Cloud ERP Solution: A scalable platform with Azure-based cloud capabilities, security by design, pre-built validation processes, and test automation delivers efficiency, security, and long-term investment protection.

Your challenge

Complex and Mixed Manufacturing Processes Process manufacturing and discrete manufacturing are difficult to manage in a single system, for example in pharma-medical device environments.

Our solution

Support for Hybrid Manufacturing and Custom Configurations: COSMO CONSULT industry solutions enable mixed manufacturing modes, including process and discrete manufacturing, as well as custom configurations, all within a single Microsoft Dynamics 365 Business Central ERP system.

No-obligation consultation

Our pharmaceutical expertise in numbers

20+

years of experience in the pharma and life sciences industry

100+

successful ERP projects in regulated environments

40%

less validation effort through GAMP 5/CSA methodology and templates

How we support the pharmaceutical industry across the value chain

Research & Development

Sales & Customer Service

Procurement & Raw Materials

Production & Batch Manufacturing

Quality Management

Packaging & Labeling

Warehousing & Logistics

Regulatory & Compliance

Reporting & Analytics

Sustainability & Recycling

Management & Controlling

Research & Development

Digital formula development and management, including documentation

Compliance-ready development processes

R&D dashboards and analytics

AI support

ERP integration

Industries where we're at home

Context slider

Medical Technology

COSMO CONSULT supports medical technology companies in optimizing processes, increasing transparency, and acting in a future-proof manner.

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Life Sciences

As a life science company, you are confronted with heavy regulation. For your team, this means extensive verification and documentation requirements. Digital transformation helps you to reduce this workload. This frees you up to bring innovative products to market faster.

Microsoft-based pharma software: compliance, efficiency & innovation

6x Microsoft Solutions Partner

Microsoft Dynamics Inner Circle

Top employer

How does COSMO CONSULT pharma software support Annex 11 and 21 CFR Part 11 compliance, two of the most critical requirements in the pharmaceutical sec

How does COSMO CONSULT pharma software reduce validation effort in the pharmaceutical industry, specifically around Computer System Validation (CSV)?

How does COSMO CONSULT simplify batch reviews and batch documentation for pharma companies?

What integrations are available in the pharma environment, such as serialization, PLM, and labeling?

What does COSMO CONSULT offer in terms of training, support, and change management? How do you drive user adoption?

How does COSMO CONSULT approach data security for pharma companies, and how are access rights managed in a cloud and 21 CFR Part 11 context?

What are the benefits of integrated quality management, covering CAPAs, deviations, approvals, and document control?

How does COSMO CONSULT support AI-powered analytics for quality management and production planning?

What pricing and deployment models are available for pharma companies, including cloud options, contract terms, and scalability?

Does COSMO CONSULT pharma software support complex manufacturing processes and mixed manufacturing modes?