Joinn Biologics Success Story

Please tell us about what Joinn Biologics does.

Joinn Biologics is a full-service premier Contract Development and Manufacturing Organization which provides services across all the phases of the drug life cycle, which includes Cell Line Development and MCB Manufacturing, Process and Analytical Development, Formulation Development, Drug Substance Manufacturing and Drug Development services.

Joinn Biologics - SyberWorks Usage Experience

About Joinn Biologics

Joinn Biologics is a full-service premier Contract Development and Manufacturing Organization (CDMO) providing services across all phases of the drug life cycle. This includes Cell Line Development and MCB Manufacturing, Process and Analytical Development, Formulation Development, Drug Substance Manufacturing, and Drug Development services.
 

Role at Joinn Biologics

As a Senior Validation Engineer, I manage the validation program, including equipment qualification, computer system validation, and manufacturing processes. I also serve as the System Administrator for SyberWorks at Joinn Biologics, maintaining validation and the system life cycle.

Benefits from Using Document Management System    

  • Easy access to documents via browser, better visibility, and search options.     
  • Reduces errors from duplicate document creation.     
  • Improves collaboration and timely notifications for required actions.     
  • Increases productivity by enabling online collaboration and approvals.     
  • Reduces paper waste and storage costs.     
  • Improves document content quality.     
  • Centrally managed document storage.     
  • Enhanced security for controlled documents.     
  • Ensures regulatory compliance.     
  • Advanced auditing and tracking capabilities.   

Benefits from Using Learning Management System     

  • Organized training management with defined plans and retraining needs.     
  • Centralized access to training materials.     
  • Clear visibility of training requirements, due dates, and reporting.     
  • Managers and auditors can easily access training records.     
  • Prevents duplicate training assignments.     
  • Ensures training on current procedure versions only.     
  • Reduces paper waste and maintenance costs.     
  • Minimizes deviations and non-conformances related to training.   

Benefits from New QMS Modules (Incident/Deviation Reports, CAPA, CCR)     

  • Improved employee time management by removing paper-based processes.     
  • Easy searching and trending of quality events by type, date, root cause, etc.     
  • Centralized data platform for informed decision-making and KPI tracking.     
  • Improved risk management through process visibility and linkage of events.     
  • Encourages employee engagement and continuous improvement.     
  • Ensures regulatory compliance with a structured approach.   

Estimated Time Savings   

Compared to paper-based processes, each quality event saves an average of 15 minutes for the employee initiating the event and 5 minutes for the approver.   

Benefits Expected from Online Forms Implementation     

  • Seamless communication across multiple sites.     
  • Reduced time spent filling and routing physical forms.     
  • Easy access and searchability of documents.     
  • Lower paper waste and maintenance costs.     
  • Improved document quality.     
  • Centrally managed storage.     
  • Increased job satisfaction for employees.   

Example Workflow  

A Deviation Report is created, which leads to a CAPA being initiated. The CAPA results in a CCR (Change Control Request). As a result, related controlled documents are updated. Based on the document changes, a new Read and Sign course is created and assigned to users depending on their job roles.       

What Do You Like Best About SyberWorks Products? 

They are user-friendly and easily customizable to meet different user requirements.      

Working with SyberWorks Consultants    

  • They quickly understand business and design requirements.     
  • Fast transition from concept to design and validation phases.     
  • Responsive to reported issues.     
  • No major service interruptions since implementation.