CASE STUDY

Integrated Electronic Quality Management System Drives Success for Joinn Biologics

Our client Joinn Biologics faced a critical challenge: streamlining their complex documentation and training processes while maintaining rigorous quality standards. 

As a premier contract development and manufacturing organization (CDMO) providing services across all phases of the drug lifecycle, Joinn Biologics required a comprehensive form management solution to ensure regulatory compliance. 

This case study explores SyberWorks’ integrated electronic Quality Management System (eQMS) empowered Joinn Biologics to:

  • Centralize quality event data for informed decision-making
  • Streamline employee training for both new hires and experienced staff
  • Enhance regulatory compliance across all processes
  • Improve product quality through data-driven insights

Read the full case study to explore how Joinn Biologics' investment in a comprehensive eQMS solution revolutionized their operations and set new standards for quality management in the biologics industry.

Pharmaceutical factory worker conducting tests
THE CHALLENGE

SyberWorks partnered with premier contract development and manufacturing organization (CDMO) Joinn Biologics, based in San Francisco, to create new functionality for automating the routing and filling out of forms. The forms include document processing requests, job role creation and modification, job role assignments, training assignments, and approvals/disapprovals of on-the-job training tasks.

Why Joinn Biologics Contacted SyberWorks

A senior validation engineer at Joinn Biologics reached out to us when their team needed a solution to streamline their processes. This person is responsible for managing and maintaining the validation program, which includes equipment qualification, computer system validation, and manufacturing processes.

The Joinn Biologics team needed a robust document management system (DMS) to handle the large workload of documentation that flows through the company on a weekly basis. It also needed a learning management system (LMS) to train employees, both new hires and experienced staffers, on new and existing processes in the complex work of drug manufacturing. An integrated quality management system (QMS) enabled Joinn Biologics to improve their products and regulatory compliance.

Joinn Biologics is a full-service premier contract development and manufacturing

organization that provides services across all phases of the drug life cycle:

  • Cell Line Development 
  • MCB Manufacturing
  • Process and Analytical Development
  • Formulation Development
  • Drug Substance Manufacturing
  • Drug Development

“We now have a centralized platform to maintain quality events data, enabling the company to collect and analyze operations, products, services, and use data. We can make informed decisions that improve overall quality."

THE SOLUTION

How SyberWorks’ Document Management System Helped Joinn Biologics

The document management system, customized to Joinn Biologics’ technology, has helped centralize and optimize the many facets of the company’s highly regulated drug production process. 

  1. Easy access to documents (via browser). The documents on computer screens or tablets have better visibility, easy search options, and reduce the time and effort wasted in locating documents.
  2. Reduces errors of creating duplicate documents. It’s simple to copy and rename documents based on the customer’s requirements when standardized documents are keys for compliance.
  3. Improves collaboration among team members. The DMS notifies collaborators on time about the collaboration and approval required actions. Customers can set up these automations to trigger certain events and notifications with ease.
  4. Increases productivity. Collaborating and approving documents online works faster instead of routing the documents manually in person for wet signatures.
  5. Reduces paper waste. It obviates a storage location needed for paperwork, leading to maintenance cost reductions.
  6. Reduces errors in documents. Better content quality happens when documents can alert users if some form submission is missed before sending or finalizing.
  7. Centrally managed document storage. All of the documents are store securely in one place.
  8. Better security for controlled documents. Administrators can limit who has access to various documents.
  9. Regulatory compliance. When FDA regulators need to see documents, they are easily found and accessible.
  10. Easy multi-site communication. No need to scan and share forms between employees working at multiple sites.
  11. Enhanced auditing and tracking capabilities. The search function can allow individuals to locate forms. Meanwhile, the CRM-like interface can track the last action that happened on forms, including if a new version was created, who was sent alerts, and what workflows are active.

How Integrating an LMS and a DMS Optimized Staff Learning at Joinn Biologics

In regulated industries like healthcare and pharmaceuticals, LMS and DMS integration is essential because both functions are similar. From document creation and approval to the collection of e-signatures, distribution based on job roles, and compliant recordkeeping, a robust LMS/DMS integration helped Joinn Biologics on every step of the company’s processes.

  1. Manage worker training. Managers and supervisors were able to train people in an organized manner with well-defined training plans and retraining requirements.
  2. Centralized learning platform for ease of use. Every employee has easy access to their training documents.
  3. Better visibility. It’s easier to see someone’s current training requirements, due dates, passed due dates, tracking, and reporting.
  4. Easy access to employee training records. This includes managers when they need to see past due dates as well as quality personnel and auditors for tracking and reporting.
  5. Avoids duplicate assignments. This makes teams more efficient.
  6. Reduces errors on new processes. Users are trained on the current versions of the procedures avoiding the errors of training on the ineffective documents and thus ensuring compliance in the procedures followed.
  7. Reduces paper waste. Digital documents are stored securely using a cloud-based solution, eliminating storage location availability and leading to maintenance cost reductions.
  8. Reduced deviations and non-conformances. This helps Joinn Biologics maintain compliance and efficiency related to employee training.

Benefits Achieved Through the Quality Management System of Joinn Biologics

In a highly regulated and competitive field, Joinn Biologics needs all of the advantages it can get when complying with federal and state regulations as well as beating competitors’ time to market.

See how our partnership benefitted Joinn Biologics with its integrated quality management system, DMS, and LMS.

  1. Improved employee time management. By eliminating the need for filling out paper-based forms and routing documents for in-person approval, staffers saved time and could focus more on core activities.
  2. Easier searches for documents. Quality management records like deviations, change controls, and CAPAs can be easily searched based on event type, date of occurrence, classifications, responsible departments, root cause category, etc., and used for trending, which is very difficult to manage without a quality document management software.
  3. Centralized platform to maintain quality events data. This enables Joinn Biologics to collect and analyze data on its operations, products, services, and use that data to make informed decisions that improve overall quality. The DMS/LMS/QMS modules also incorporate key performance indicators and metrics, so decision-makers can quickly identify areas of improvement and act to address them.
  4. Improved risk management. By linking different events and processes like deviation reports, CAPA, and CCR, controlled documents can establish clear visibility of the processes for risk identification, assessment, and mitigation. This ensures processes are consistently followed across the organization, preventing risks from occurring or minimizing their impact.
  5. Increased employee engagement. The LMS and DMS integration has increased job satisfaction and provides a framework for continuous improvement. It also encourages employees to identify areas of improvement and take ownership of the process.
  6. Improved regulatory compliance. The QMS provides a structured framework to identify and understand the regulatory requirements, leading to improvements.

How Much Time Joinn Biologics Has Saved With an Integrated DMS/LMS/QMS

When compared to the paper-based process, each event saves an average of 15 minutes of the employee’s time who is initiating the event and five minutes of the employee’s time who is approving the event.

What Joinn Biologics Likes Most About SyberWorks’ Products & People

At the end of the day, what you’re building matters. And we love building relationships with our clients. Joinn Biologics enjoys the user-friendly and customizable experience of our platforms to meet different user requirements. 

Joinn Logistics noted that the SyberWorks team quickly understood the business and design requirements of the client’s team. The transition time taken from concept phase to design and validation is short.

Any issues reported by the client were handled quickly and effectively with no major interruptions since implementation. 

Unlock Your Company’s Operational Efficiency With SyberWorks

Our quality management system, document management system, and learning management system can help you and your teams become more efficient on several fronts. From industry compliance and quality assurance to automated training and document approval, SyberWorks can help. 

Request a demo with our team to discover how we can help your organization succeed.

About SyberWorks

With over 25 years experience delivering technology to meet the needs of highly regulated organizations, SyberWorks is the market leader in tailored, compliant learning experiences.