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Streamline processes for compliance and efficiency with our biotech ERP 

Modern biotechnology delivers innovative products and technologies that tackle severe and uncommon illnesses, reduce our carbon footprint, promote sustainable and efficient energy use, and enable safer, cleaner, and more efficient industrial production methods. However, they need to adhere to stringent government standards, keep pace with fast-changing technology, and navigate unpredictable market dynamics.  

To enhance your company’s efficiency while upholding the highest standards of regulatory compliance, you need software that integrates your biotech company’s critical data, from scientific research to financial management seamlessly, all within a single, intuitive platform. 

Our biotech ERP helps fine-tune every aspect of your operations, from production to clinical trials. As your company grows, our biotech software evolves with you, ensuring your regulatory and security requirements are never compromised. Embedded in Microsoft Dynamics 365 Finance and Supply Chain Management, our solution helps you meet industry standards.

Key Challenges

Regulatory non-compliance

Inconsistent record-keeping and approval processes, inadequate traceability, inefficient change management, and disconnected systems may lead to regulatory non-compliance, resulting in legal action, penalties, and market restrictions. 

Extensive paperwork
Extensive documentation and manual workflows deter innovation and introduce multiple errors leading to rework, expensive mistakes, and non-compliance.
Inefficient supply chain management
Limited visibility, inefficient inventory and supplier management, and poor tracking become reasons for an inefficient supply chain. The absence of a robust biotech ERP results in increased expenses and quality issues.  

Key Features

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    Regulatory compliance

    Ensure compliance through audit trail implementation, secure batch review, approval processes with electronic signatures to GxP critical fields and tables, real-time monitoring, and end-to-end traceability using our biotech ERP. 

    Supply chain management

    Avail all inventory information including location, license plate, item, batch (lot), sub-batch (container), and quantity with a single barcode scan. Maintain an approved vendor, manufacturer, and supplier list. Store inventory as per protocols. 

    Data management

    Manage data and compliance by validating the data through staging tables, setting up access levels to the data, and improving traceability through an audit trail.   
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    Benefits

    Facilitate innovation

    Integrate with R&D systems and establish seamless data transfer from research to production.

    Streamline supply chain management

    Regulate inventory, procurement, and distribution processes to enable better tracking and control over the supply chain.

    Gain real-time data and security

    Avail seamless data sync, dynamic visualizations, and data security to reduce business risks.

    Enable end-to-end traceability

    Gain transparent insights into your consumption and movement operations by integrating data from across your supply chain. 

    Enhance customer relationship

    Boost customer service by integrating operations and unifying communication. 

    Ensure regulatory compliance

    Ensure compliance with regional and international regulations, FDA 21 CFR Part 11, and EU GMP Annex 11 guidelines with our biotech software.

    Functionality

    Compliance Management

    Compliance Management

    Ensures adherence to industry regulations like FDA 21 CFR Part 11 and EU GMP Annex 11. Maintains comprehensive audit trail for inspection and audits. Facilitates electronic signature for approvals. 
     

    Traceability

    Traceability

    Tracks and traces batch, sub-batch, and container records ensuring traceability compliance.

    Inventory Management

    Inventory Management

    Optimizes inventory levels by real-time tracking. Ensures prescribed storage conditions are maintained to avoid material spoilage.

    Supply Chain Management

    Supply Chain Management

    Manage suppliers, manufacturers, and distribution channels to ensure timely delivery to the market.

    Label Printing

    Label Printing

    Prints shipping and product labels automatically for traceability. Designs printer logic as per user group, zone, warehouse, and locations.  

    Frequently asked questions

    Can't find what you're looking for?

    What ERP features are crucial for biotech companies?

    Features that support complex manufacturing processes, regulatory compliance, and intricate supply chain dynamics are crucial for biotech companies. Our solution meets standard industry requirements out-of-the-box, eliminating the need for expensive customizations and integrations.

    How can a biotech ERP ensure compliance with regulations?

    A biotech ERP should have features that provide comprehensive audit trails and sophisticated reporting tools to ensure compliance with critical regulations such as the FDA's 21 CFR Part 11, EMA guidelines, and GMP standards. Our Life Sciences Validation Toolkit provides templates and documentation to streamline the system's validation.

    What considerations should we have while selecting biotech software?

     

    Assess how well the biotech software handles manufacturing processes specific to biotech industries, such as regulatory compliance, quality control, supply chain management, warehouse management, weighing and dispensing, etc. 

    How does an ERP support quality control in biotech manufacturing?

     

    The biotech ERP should have robust quality control modules that support in-process inspections, non-conformance tracking, and CAPA (Corrective and Preventive Actions).  

    Is cloud-based biotech software suitable for biotech organizations?

    Cloud-based biotech software offers flexibility, scalability, and remote access, which can benefit organizations with multiple locations or those requiring mobile access. It is safer than on-premises software because cloud providers like Microsoft have stricter security protocols than any biotech company could implement on their own. Cloud-based software security features include access controls, data encryption, and server-based processing.

    How can an ERP improve operational efficiency in biotech companies? 

    Biotech ERP streamlines processes, reduces manual errors, improves inventory management, enhances data visibility, ensures compliance with industry regulations and guidelines such as FDA 21 CFR Part 11 and EU GMP Annex 11, and ultimately leads to cost savings and enhanced productivity.

    Resource Center

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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.
      Features and benefits of STAEDEAN Pharma and Biotech solution

      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.
      Benefits of using modern ERP systems

      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.
      Sector-specific, modern ERPs save cost and enhance market value

      Digital Quality Control Systems/Laboratory Information Management Systems (LIMS) and the Evolution of CDMOs

      Massimo CrudeliMassimo Crudeli
      Oct 3, 2023
      Laboratory Information Management Systems (LIMS) can help you outpace your competition. Read the blog to understand its benefits for your organization.

      Do CDMOs have to go the ERP Way?

      Massimo CrudeliMassimo Crudeli
      May 30, 2023
      STAEDEAN Biotech ERP is designed to help your company scale up, stay compliant, and generate revenue. Read the blog to know more.
      Need for CDMOs to adopt ERP

      Know which ERP works the best for you

      Massimo CrudeliMassimo Crudeli
      Feb 28, 2023
      Choosing the right ERP for your Biotech company can be challenging. Read the blog for insightful guidance.
      Things to know before you choose an ERP
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