Challenges:

• Inefficient Document Control: The client's existing document control process was cumbersome, leading to delays in document approval and release. This impacted the timeline for usability engineering studies and product development.

• Design Change Management: Implementing design changes required extensive documentation, but the process was inefficient and error-prone, leading to frequent rework and miscommunication among teams.

• Regulatory Compliance: Ensuring that all documents met regulatory standards was time-consuming, with the risk of non-compliance due to the manual nature of the process.

ClariMed’s Approach:

We worked closely with the client's quality and engineering teams to understand their existing processes and identify key pain points. Our approach included:

1. Process Mapping and Gap Analysis: We began by mapping the client's existing document control process to identify inefficiencies and areas for improvement. This involved a thorough gap analysis to pinpoint where delays and errors occurred most frequently.

2. Customized Document Control System: We recommended and implemented a customized electronic Document Control System (DCS) tailored to the client's specific needs. The system was designed to streamline document creation, approval, and release processes while ensuring compliance with regulatory requirements.

3. Automated Workflows: We introduced automated workflows for document approvals, significantly reducing the time required for document reviews and ensuring that the right stakeholders were involved at each stage of the process. 

4. Training and Change Management: To ensure smooth adoption of the new system, we provided comprehensive training to the client's teams. We also implemented change management strategies to help them transition from their old manual processes to the new automated system.

5. Integration with Design Change Management: We integrated the DCS with the client's design change management system, enabling seamless updates and ensuring that all related documents were automatically updated and compliant.

Results:

• Faster Document Release: The new document control system reduced the document approval and release timeline by 40%, allowing the client to prepare for usability engineering studies more quickly and efficiently.

• Improved Design Change Process: The integration of the DCS with the design change management system streamlined the implementation of design changes, reducing errors and ensuring that all documentation was up-to-date and compliant.

• Enhanced Regulatory Compliance: Automated workflows and standardized processes improved the accuracy and completeness of documents, reducing the risk of non-compliance and ensuring adherence to regulatory standards.

• Increased Productivity: By automating repetitive tasks and streamlining workflows, the client's teams were able to focus on higher-value activities, leading to a 30% increase in overall productivity.

Conclusion:

Our tailored approach to document control and design change management helped the auto-injector manufacturer significantly improve their processes. The streamlined document control process not only sped up document release but also ensured that the client could confidently move forward with usability engineering studies and product development, ultimately enhancing their competitive edge in the market.

Learn more about ClariMed Quality Services.