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Pharma companies carry a huge responsibility―delivering safe and effective drugs to patients. Even a minor slip-up can have severe consequences for people’s lives. To ensure safety, pharma companies must adhere to the stringent domestic as well as international rules laid down by global regulatory bodies like the FDA and EMA. But that's not all—they also need flawless supply chains for timely delivery, outstanding quality, and tight cost control to stay ahead.  

Embedded in Microsoft's top-notch Dynamics 365, STAEDEAN’s pharma ERP software helps manage every step of your manufacturing process in a single system. Our software helps efficiently manage supply chains, finances, and compliance. With complete visibility into operations, you can cut costs and tackle issues like process variability, downtime, and security threats. What’s more? With Microsoft's Copilot, you can even use AI to work better. 

Scroll down to find out how our pharma ERP software can benefit you! 

Key Challenges

Changing regulatory compliance
Each year, the FDA issues numerous warning letters to pharma manufacturers for non-compliance. With our pharmaceutical ERP software, keep up with global regulatory changes, collect all required data, and ensure compliance with GxP.
Quality control issues
Process variability directly affects quality. Minor modifications can impact drug interaction, causing recalls. Identify and rectify variability with real-time insights and advanced analytics to improve quality control.
Complex supply chain
Coordinating with numerous stakeholders and meeting specific storage needs are challenging. Handle disruptions—like natural disasters and regulatory changes—adeptly to prevent shortages and delays.

Optimize supply chain

Enable product tracking with configurable item and batch numbers. Block sub-batches if damage or quality issues arise. Evaluate vendors with pre-approved lists based on performance and compliance history.

Manage warehouse and inventory

Use a single scan to identify the material, display material properties, verify handling instructions, get alerts for code mismatches and print inventory labels. 

Strengthen security and compliance

Get advanced warehouse management security compliant with 21 CFR Part 11 and EU Annex 11. Enable access control at a granular level, down to till fields and buttons. Track user actions (new, modified, deleted records), including user, date, time, and field values. Use approval workflows and second-person verification for quality compliance.
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Benefits

Elevate operations

With visibility into each stage of the supply chain, make informed decisions to improve efficiency, reduce costs, and ensure timely delivery of products to customers.

Gain competitive advantage

Establish a reputation for quality and reliability by delivering quality products faster to the market. Improve your market share and get a competitive edge.

Improve demand forecasting

Reduce the risk of stockouts or overstocking, minimize downtime, optimize inventory, improve operational efficiency, and meet the needs of patients by forecasting demand effectively. 

Enhance working capital

Enhance cash flow forecasting with real-time financial insights, leading to better liquidity and reduced financial risk.

Improve budgeting

Manage production costs with insights into real-time data. Get accurate financial data to forecast and plan your budget with ease.

Boost profitability

Avoid costly fines, safeguard public health, uphold the brand reputation, foster long-term profits by adhering to regulatory requirements, and ensure compliance.

Functionality

Product Information Management

Product Information Management

Classify items, define their properties, manage item specific rules for receiving, storing and shipping process, define the level of traceability desired. 

Supply Chain Management

Supply Chain Management

Boost efficiency and cut costs with end-to-end supply chain visibility. Track products, identify issues, and make changes using accurate data. Evaluate vendors based on performance, quality, and compliance to improve product quality and customer satisfaction.

Warehouse Management

Warehouse Management

Monitor all warehouse activities and streamline processes by tracking the movement of all materials at any time in any location. Reduce manual paperwork related to warehouse operations by maintaining reports, packing lists, and more digitally.

Weighing and Dispensing

Weighing and Dispensing

Accurately measure and distribute drugs according to predefined specifications. Manage potency adjustment, scale requirements, weighing tolerances, training needs, personal protective equipment requirements, container sizes, calibration, and much more.

Data Integration

Data Integration

Unify your data and eliminate the complexities of multiple systems. Gain end-to-end visibility across the supply chain. Get real time access to vast amounts of data that can help with supply chain processes and decision making.

Security and Compliance

Security and Compliance

Manage data security, mitigate risk, and handle audit and compliance. Stay secure and compliant with regulations like FDA 21 CRF part 11 or EU GMP Annex 11 by ensuring a complete audit trail. Manage access to the system regardless of the entry point properly and define the allowed actions till the function and field levels 

Frequently asked questions

Can't find what you're looking for?

How do I evaluate ERP vendors for pharmaceuticals? 

It is important to consider the vendor’s experience in the pharma sector, the scalability of their solution, customer support, and the total cost of ownership. Check for references from other pharma companies and choose the one that offers best practices and accelerator.

What ERP features are crucial for pharmaceutical companies? 

Look for features that support complex manufacturing processes, regulatory compliance, and intricate supply chain dynamics. Check for software that can support Laboratory Information Management System (LIMS), Advanced Warehouse Management, and Weighing & Dispensing. 

How does your system ensure compliance with pharma regulations? 

Our system automates compliance with regulations, such as FDA’s 21 CFR Part 11, EMA guidelines, and EU GMP Annex 11 standards, providing comprehensive audit trails and sophisticated reporting tools. In addition, STAEDEAN Life Sciences Validation Toolkit offers templates and documentation to streamline system validation. 

How does your ERP support quality control in pharma manufacturing? 

We have robust quality control modules that support in-process inspections, non-conformance tracking, and corrective and preventive actions. Our solution offers all the tools in one place: you will no longer require a separate Laboratory Information Management System (LIMS) for pharma and life sciences Quality Management System (QMS). 

How can your ERP improve operational efficiency in pharma companies? 

Our solution, embedded in Microsoft Dynamics 365 F&SCM, streamlines processes, reduces manual errors, improves inventory management, enhances data visibility, ensures compliance to industry regulations, such as FDA 21 CFR Part 11 and EU GMP Annex 11, that ultimately results in increased productivity. 

Resources

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    Pharma and Biotech ERP Factsheet

    Find out how you can manage inventory efficiently, optimize workflows, and enhance compliance adherence using our industry-specific ERP.
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    Modernizing ERP systems - A guide for Life Sciences

    Discover the importance of moving to the cloud. Learn the key migration steps and why choosing the right ERP partner is crucial for seamless cloud implementation.
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    How your company can boost its market value - An eBook

    A Dynamics 365 upgrade can save you USD 10.6 million! Know more about it and other benefits of technological advancements in life sciences industry.
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    Reducing Safety Risks in Pharmaceutical Manufacturing

    Jan 1, 1970
    Modern data management, through a fully compliant ERP system, can help life sciences organizations comply with regulations and follow GMP standards.

    What’s the Best ERP System for the Pharmaceutical Industry?

    Jan 1, 1970
    Strengthen your pharmaceutical business with the right ERP solution. Read the blog to learn about the key features and capabilities you should look for.

    How STAEDEAN Life Sciences Solution Helps Comply with FDA ICH Q6A

    Jan 1, 1970
    Ensure compliance with FDA ICH Q6A requirements and efficiently manage specifications with the right ERP features. Learn how STAEDEAN’s Life Sciences solution can help.
    How STAEDEAN Life Sciences Solution Helps Comply with FDA ICH Q6A
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