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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.  

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

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    Know which ERP works the best for you

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