A Life Sciences Manufacturer boosts quality, efficiency, compliance, and traceability in bulk batch production

Highlights:

• Manual Process Challenges: The client struggled with inefficiencies and errors due to paper-based batch records and manual sign-off processes, leading to costly mistakes and difficult record access.
• Regulatory Compliance Needs: The existing system could not support CFR 21 Part 11 regulations for electronic records and signatures, necessitating a more robust solution.
• Transformative Solution: Implementing TrakSYS by Parsec™, configured by Adatafy™, streamlined operations, ensured compliance, improved traceability, and reduced errors, setting the stage for future scalability and operational excellence.

Customer

A global manufacturer of lubricants and soaps used in the medical industry, with operations at a Midwest USA site.

Challenge

The client faced significant challenges in managing their bulk batch production processes. They were using paper batches in Excel, printing them off, writing by hand, and then going through a sign-off process before saving them in a binder. This manual workflow made it difficult to access records easily.

Another major issue was the risk of accidentally dispensing the wrong product, which happened a couple of times a year, resulting in increased costs due to the loss of raw materials, product, and time.

Additionally, the company needed to comply with CFR 21 Part 11 regulations for electronic records and signatures, which their existing framework could not support.

Solution

The client chose TrakSYS, a best-in-class manufacturing operations management system, to address their challenges. Software engineers at Adatafy™, a Novaspect trademark, configured the TrakSYS system to manage bulk batch production, recipe management, and material traceability.

System features included:

• Electronic Records and Signatures: Ensuring compliance with CFR 21 Part 11.
• Audit Control: Enhanced control over the development of system solutions around signatures and signoffs.
• Material Traceability: Automated tracking of raw materials and finished products.
• Standardized Processes: Formalized and standardized operating procedures, replacing informal and paper-based methods.
• Data Repository: Centralized data management system for recording and future reference.
• Workflow Management: Customizable workflows to match the company’s unique processes.
• Integration Capabilities: Seamless integration with Warehouse Management Systems (WMS), Computerized Maintenance Management Systems (CMMS), and Enterprise Resource Planning (ERP) Systems.

Outcome

The successful implementation of TrakSYS transformed the client’s manufacturing operations and led to significant improvements:

• Reduced Errors and Improved Efficiency: The implementation of TrakSYS minimized the risk of using incorrect raw materials, significantly reducing costly production errors and streamlining operations through standardized processes and electronic records.
• Enhanced Compliance and Traceability: The system ensured compliance with CFR 21 Part 11 regulations and improved material traceability, allowing for easier tracking and auditing of production batches.
• Scalability and Future Expansion: TrakSYS’s flexibility and scalability supported future expansions and additional functionalities, setting the stage for continued improvements.

The project demonstrated the system’s ability to enhance efficiency, compliance, and traceability, setting the stage for future expansions and continued improvements. The client is now better equipped to meet industry standards and regulatory requirements, ensuring high-quality production and operational excellence.

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FAQ

What are electronic/digital work instructions?

Electronic or digital work instructions are modern, paperless versions of traditional work instructions and standard operating procedures (SOPs). Digital work instructions are available on various devices, making it easy for workers to access instructions anytime, anywhere. Information is used for training and transferring expert knowledge to employees and can be updated in real-time to reflect current procedures. They often include multimedia elements like images, videos, and interactive components to enhance understanding. Data can synchronize with other digital systems, such as IoT devices or enterprise resource planning (ERP) systems, to provide greater flexibility across platforms.

What is CFR 21 Part 11 regulations for electronic records and signatures?

CFR 21 Part 11 is a set of regulations established by the FDA to ensure that electronic records and electronic signatures are trustworthy, reliable, and equivalent to paper records and handwritten signatures. Here are some key points:

• Scope: The regulations apply to electronic records and signatures used in FDA-regulated industries, such as pharmaceuticals, biotechnology, and medical devices.
• Requirements: The regulations specify criteria for system validation, audit trails, record retention, and security controls to ensure the integrity, authenticity, and confidentiality of electronic records.
• Compliance: Companies must validate their systems to ensure they perform accurately and reliably, maintain audit trails to track changes, and implement security measures to restrict access to authorized individuals.

These regulations help ensure that electronic records and signatures are as reliable as their paper counterparts, supporting the integrity of data in critical industries.

How can you improve traceability in bulk batch production?

Improving traceability in bulk batch production involves several key strategies and technologies. Here are some effective ways to enhance traceability:

1. Implement an MES (Manufacturing Execution System):
   • Use systems like TrakSYS to track and document the transformation of raw materials into finished products in real-time.
   • MES can provide detailed records of each batch, including raw material sources, processing steps, and final product destinations.
2. Use Barcode and RFID Technology:
   • Apply barcodes or RFID tags to raw materials, intermediate products, and finished goods.
   • These technologies enable automatic data capture and real-time tracking throughout the production process.
3. Centralized Data Management:
   • Utilize a centralized database to store all production data, ensuring that information is easily accessible and consistent.
   • This helps in maintaining a single source of truth for all traceability data.
4. Standardize Processes:
   • Develop and implement standardized operating procedures (SOPs) for all production activities.
   • Ensure that all steps are documented and followed consistently to maintain traceability.
5. Electronic Records and Signatures:
   • Replace paper-based records with electronic records to improve accuracy and accessibility.
   • Use electronic signatures to ensure compliance with regulations like CFR 21 Part 11.
6. Integration with Other Systems:
   • Integrate the traceability system with other enterprise systems such as ERP, WMS (Warehouse Management System), and CMMS (Computerized Maintenance Management System).
   • This integration ensures seamless data flow and comprehensive traceability across the entire supply chain.
7. Regular Audits and Inspections:
   • Conduct regular audits and inspections to verify that traceability processes are being followed correctly.
   • Use audit trails to track changes and identify any discrepancies in the production process.
8. Training and Awareness:
   • Train employees on the importance of traceability and how to use the traceability systems effectively.
   • Ensure that all staff understand their roles in maintaining accurate and complete traceability records.

By implementing these strategies, you can significantly improve traceability in bulk batch production, leading to better quality control, regulatory compliance, and overall operational efficiency.