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Supply Chain Management

Life sciences companies, whether in pharma, biotech, clinical supplies, or medical devices, have complex supply chains. They must ensure smooth and efficient operations while adhering to strict regulatory guidelines because their products significantly impact patients’ health. Ensuring the procurement of high-quality materials from reliable distributors is critical, as even minor variations in quantities can alter product effectiveness and safety.  

End-to-end visibility and strong coordination with stakeholders are essential to deliver quality products faster to the market. To strengthen the supply chain, making it resilient to disruptions like the global pandemic is the need of the hour. Additionally, integrating advanced technologies like AI to fuel growth and stay competitive is essential.  

STAEDEAN’s pharmaceutical supply chain software, embedded in Microsoft’s Dynamics 365 ERP software, is developed to effectively manage the complexities of product development and supply chain. 

Scroll down to check how our pharma supply chain software can benefit you. 

Key Challenges

Make supply chain resilient
The pandemic exposed major weaknesses in life sciences supply chains globally. With our pharmaceutical supply chain software, enhance visibility across your supply chain and improve collaboration with suppliers and distributors to respond faster to disruptions and manage inventory in real time.
Tackle compliance issues
Regulations are complex and require companies to comply with various rules across locations while maintaining top product quality. Strengthen quality management and stay up to date with regulatory changes.
Embrace technology & drive growth
To stay competitive and meet the demands of personalized medicine, life sciences companies must adopt AI technologies. Embrace AI-enabled ERP software to lead the industry, improve cost efficiency, and drive growth.

Information handling

Comply with quality standards using approval workflows and compliant e-signature for sensitive data and processes. Organize information coming from different sources and configure rules to facilitate your decision process. 

Storage and distribution

Manage complex logistical and regulatory requirements using authorized distributors, proper storage conditions, material handling rules, and qualified distributor center and final customers.

Material tracking and monitoring

Define material unit with configurable items and monitor it. In case of damage or quality concerns, block specific units to safeguard the patient’s well-being and protect your company's reputation.
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Benefits

Avoid complex integrations

Track and monitor every phase of your supply chain with unified ERP software. Eliminate the complexities and costs associated with managing separate ERP, LIMS, and Dispensing systems.

Stay compliant

Meet the EU GMP Annex 11 and the FDA 21 CFR Part 11 regulations using audit trail, multi-step approval workflow, vendor and manufacturer qualification, security of sensitive records, and more.

Improve supply chain visibility

Get real-time visibility into supply chain operations, improve transparency across your organization, make informed decisions, and grow your business.

Strengthen product quality

Improve coordination for all the stakeholders involved in the supply chain, enhance quality, and reduce product waste through end-to-end visibility. 

Improve process efficiency

Automate manual or paper-based processes to reduce effort and errors. Get insights into data and view accurate information in real time.

Stay competitive with advanced technologies

Quickly analyze vast amounts of data and work with data faster using Microsoft’s AI Copilot.

Functionality

Maintain compliance

Maintain compliance

Stay compliant, ensure traceability, and maintain a secure record of transactions and changes with approval process, audit trail and electronic signatures and documents.

Follow regulatory standards

Follow regulatory standards

Ensure rigorous adherence to regulatory standards across supply chain and finance operations. Get electronic signature fully compliant with FDA 21 CFR Part 11. Enhance database with log/audit trail capabilities and full lot genealogy.

Manage stakeholders

Manage stakeholders

Evaluate and manage vendors, manufacturers, and customers by ensuring all parties meet predefined quality and compliance standards, streamlining procurement, production, and sales processes.

Identify material

Identify material

Streamline the entire material lifecycle, from classification and verification to labeling and advanced reporting. Manage sub-batches end to end. Get visibility into material type, material sub-type, and sub-batch type.

Return and destruction

Return and destruction

Support efficient and compliant disposal processes within supply chain operations.

Frequently asked questions

Can't find what you're looking for?

Does your solution offer an audit trail? 

In compliance with FDA 21 CFR Part 11, our solution can help record any event (new, modified, or deleted record), the user who performed it, the date and time, and the previous and current values of the modified field. 

The solution can generate all types of records in electronic and human-readable format. It is possible to export all the content of the electronic reports into several standard formats (Microsoft Office, PDF, XML). Inquiry forms, reports, and audit trails are available for batch history, quality order results entry, review and validation, creation and approval of products, BOM and routes, production order processing, maintenance order updates, and more. 

Can the solution track container inventory? 

Yes, you can trace inventory on hand, even at the sub-batch level (i.e., containers or specific portions of a batch). You can define expiration dates for a single sub-batch and the capability to block them individually in case of quality issues. 

Is it possible to define a multi-step approval workflow for items? 

Yes, it is possible to define a fully customizable approval workflow, including multiple reviews, conditional decisions, and approval steps that can vary depending on the type of product and other criteria. Our solution ensures that an item is approved before it is transacted. 

Does your solution support vendor and manufacturer qualifications? 

Yes, our solution provides the capability to define a list of approved vendors and manufacturers by item. Based on the setup, the system prevents the creation of purchase orders from a non-approved vendor and/or a non-approved manufacturer. 

Is second-person verification for changes to sensitive records possible? 

You can approve data changes via workflow for key GMP fields in the system. The solution allows an authorized user to approve/reject the modifications applied by another user for second-person checks and approval. For the audit trail, it provides the full history of modification to controlled fields, including the username of the approver, approval date, and time. 

Resources

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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.
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    Resolve to End Drug Recalls in 2024

    May 29, 2024
    Avoid costly drug recalls and protect your reputation with full visibility into production processes. Read this blog to learn about the recall prevention strategy.

    Parenteral Drug Manufacturing: Opportunities, Challenges, and Solutions

    Jan 1, 1970
    Parenteral drug production is mired with manufacturing issues, supply chain disruptions, and regulatory changes. How can CDMOs tackle these challenges? Read to find out.

    Transform Your Life Sciences Supply Chain with AI

    Jan 1, 1970
    5 benefits Life Sciences companies can gain from intelligent process automation, natural language understanding, and other AI capabilities.

    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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    Clinical Supplies ERP Factsheet

    Explore how our ERP helps control costs, improve demand forecasting, and enable complete visibility in your process and production along with its features.
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    Medical Devices ERP Factsheet

    Learn how you can streamline production, stay compliant, and boost collaboration to achieve sustainable growth and drive innovation.
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