Medical device companies operate in a highly regulated industry where quality, compliance, and traceability are imparative. One of the most critical processes in this domain is managing change controls. From product design updates to process enhancements, every change must be tracked, documented, and approved according to regulatory standards.

For one medical device company we work with, this process was initially manual, error-prone, and inefficient, allowing for only 30 change controls per month. However, with the implementation of our powerful workflow automation platform, they scaled their change control capacity to an impressive 500 per month at time of writing. Our team shares how FlowWright’s automation capabilities revolutionized the company’s operations.

The Challenge: Manual Process, Limited Throughput

Initially, the company’s change control process was manual and paper-driven. Requests for changes were submitted via spreadsheets or email, requiring multiple handoffs between departments. Key pain points included:

1. Manual Data Entry: Employees had to re-enter information into multiple systems, leading to duplication of effort and increased potential for human error.
2. Lengthy Approval Process: Changes required approval from multiple stakeholders, often involving back-and-forth email chains, delays, and missed deadlines.
3. Poor Traceability: Auditing the status of a change was difficult. It often required reaching out to multiple people, leading to further delays.
4. Limited Capacity: The team could only process about 30 change requests per month due to the resource-intensive nature of the manual workflow.

The company recognized the need for a scalable, automated solution to improve capacity, accuracy, and speed. After evaluating several workflow automation platforms, they selected FlowWright for its robust process automation, seamless integration capabilities, and support for regulatory compliance.

The Solution: FlowWright’s Automation Platform

Our platform enabled the company to shift from manual, disjointed workflows to a fully automated change control process. The core elements of the solution included:

1. Digital Change Control Requests: FlowWright’s forms functionality was used to create dynamic, user-friendly change request forms. Employees could submit change requests directly from a web portal, reducing reliance on email and spreadsheets.
2. Automated Workflows: Change control workflows were mapped, automated, and enforced with FlowWright’s drag-and-drop process designer. Each request followed a structured, pre-defined process from submission to approval, ensuring compliance and eliminating delays.
3. Automatic Notifications & Escalations: FlowWright’s notifications ensured that stakeholders were instantly notified when their review or approval was required. If delays occurred, escalations were triggered automatically.
4. System Integrations: FlowWright’s API integration connected to the company’s quality management system (QMS) and enterprise resource planning (ERP) system. This eliminated manual data re-entry, ensuring seamless data flow across departments.
5. Audit Trail & Reporting: Every step in the change control process was automatically logged. FlowWright’s reporting capabilities provided real-time status updates and end-to-end traceability, essential for regulatory compliance.

Key Features of Our Enterprise Automation Platform

1. No-Code Visual Workflow Designer: FlowWright’s intuitive workflow designer allowed the company’s quality assurance (QA) team to create, modify, and optimize workflows without writing a single line of code.
2. Built-in Compliance: With features like electronic signatures, audit trails, and secure user authentication, our software supported the company’s compliance with regulatory standards such as FDA’s 21 CFR Part 11.
3. Scalability: As change control volume grew from 30 to 500 requests per month, our scalable architecture ensured that processing capacity increased without performance degradation.
4. Task Automation: Routine tasks, like document generation and approval routing, were fully automated, significantly reducing administrative burdens on the team.

The Result: Growth. 30 to 500 Change Controls Per Month

By implementing our platform, their change control process was transformed, leading to remarkable improvements in throughput, compliance, and operational efficiency. Key outcomes included:

1. Throughput Increase: By automating manual tasks, the company’s capacity skyrocketed from 30 to 500 change controls per month. This 1500% increase in capacity allowed the company to support product updates, process improvements, and regulatory changes at scale.
2. Time Savings: Previously, the approval process for a single change control could take days or even weeks. With FlowWright’s automated workflows, approvals were processed in hours, significantly accelerating the time-to-market for critical changes.
3. Error Reduction: Human errors caused by manual data entry were eliminated. Automation ensured consistent and accurate data entry across systems.
4. Improved Compliance: The company’s audit process became seamless. With end-to-end traceability and electronic signatures, the company could demonstrate full regulatory compliance during audits.
5. Resource Optimization: Employees previously dedicated to managing email chains, chasing approvals, and handling paperwork could now focus on higher-value tasks. This resulted in increased employee satisfaction and reduced burnout.

Hear what they have to say about the results

“FlowWright’s automation platform was a game-changer for our change control process. What used to take days now takes hours, and we’ve gone from handling 30 change controls a month to 500. The process is faster, more accurate, and fully compliant. Our team has more time to focus on innovation rather than administrative tasks.” — Quality Assurance Director, Smallbone Innovations

How FlowWright Leads The Industry

The medical device company selected FlowWright over other automation platforms due to several key differentiators:

1. Industry-Specific Compliance: FlowWright’s support for 21 CFR Part 11 compliance made it an obvious choice for regulated industries.
2. Easy Customization: Unlike rigid platforms that require technical development, FlowWright’s low-code approach enabled internal teams to tailor workflows, notifications, and forms to meet their unique business needs.
3. Seamless Integration: With robust API capabilities, FlowWright could easily integrate with existing QMS, ERP, and document management systems.
4. Cost-Effective Scalability: The company’s change control volume increased by 1500%, but FlowWright’s scalable platform handled the increase without requiring additional hardware or licenses.

Key Take Aways

1. Start Small, Scale Fast: The company started with a single department and scaled the automated process company-wide as they experienced success.
2. Leverage No-Code Capabilities: By using FlowWright’s no-code designer, the quality team was able to build and customize workflows without relying on developers.
3. Prioritize Compliance: Regulatory compliance was a key factor, and our out-of-the-box compliance features simplified the audit process.

The journey from 30 to 500 change controls per month is a testament to the transformative power of automation. By leveraging our no-code automation platform, this medical device company achieved operational excellence, reduced risk, and improved compliance.

Ready to scale your change control process? Schedule a demo to explore our features and discover how it can transform your organization’s enterprise workflow automation software.