Real-Life Results from Implementing Compliance Management Systems

Companies today implementing automated compliance management systems are motivated by a wide variety of factors.

For many, it’s about reducing manual labor hours required to execute quality processes—and achieving greater efficiency and effectiveness in their operations. For others, the priority is building a rock-solid compliance program that protects customers and the business from risk.

Rather than being a cost sink, however, implementing an automated compliance management system can deliver staggering results, in some cases saving hundreds of thousands of dollars annually.

To see how, we explore eight real-life stories below of what organizations across a range of industries have achieved by automating compliance.

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1. Contract Manufacturer Achieves Zero Findings on ISO 13485 Audit

A contract manufacturer in custom blending and extrusion of biomedical polymers and additives faced significant challenges around a shared corporate QMS that wasn’t built for FDA compliance. The company led its QMS implementation with AssurX Document Management and Training Management solutions to support its goals around data integrity and secure document access.

As a result of deploying a compliance management system, the contract manufacturer achieved:

• Zero findings on ISO 13485 audits
• Significantly reduced labor hours for document creation, approval, and routing
• Complete visibility into employee training completion, on-time training, and overdue tasks

 2. Diagnostic Imaging Manufacturer Achieves $266,000 in Savings

A global manufacturer of diagnostic imaging agents was struggling with the complexity of using multiple quality management applications. Legacy applications with minimal integration and compatibility issues lived on 18 servers, increasing costs and compliance risks.

The manufacturer deployed 16 processes as part of its compliance management system, creating simplified workflows and engaging AssurX in data migration and training to streamline implementation. Results included:

• Nearly 20,000 lifecycle documents and 100,000 training records migrated
• Server maintenance costs reduced by 65%, with licensing costs reduced by 90%
• More than 3,000 personnel hours saved
• Total savings of $266,000 in first year

All in all, the manufacturer more than doubled its number of quality processes while simultaneously achieving significant savings and increasing user efficiency.

3. Pharma & Chemicals Manufacturer Saves More than 10,000 Personnel Hours Per Year

A global pharmaceutical and chemical company using paper and spreadsheets implemented multiple QMS solutions to integrate their processes, including CAPA Management, Complaint Handling, Supplier Quality Management, and Audit Management.

Within two weeks of deployment, over 400 users were using the new compliance management system without administrator support. Within three months, daily meetings were no longer required, with real-time status of defects and events immediately visible in the system.

As a result of implementing an integrated compliance management system, the company was able to:

• Eliminate 800 personnel hours per audit
• Save 1,400 personnel hours from elimination of manual information gathering
• Eliminate 2,100 personnel hours on manually logging defects
• Save 3,000 personnel hours by eliminating in-person meetings
• Reallocate 1.5 full-time employees to more value-added work

4. Highline Warren Saves 20 Hours Per Week with Automated Document Management and Corrective Actions

A leading national manufacturer of automotive maintenance products with over $1B in annual revenue turned to AssurX to address challenges around time-consuming corrective action and document management processes.

Before implementing the software, a single employee was responsible for managing all documents such as forms and SOPs. This required spending a disproportionate amount of time sending emails and chasing down reviews and approvals. In addition, the company’s corrective and preventive action (CAPA) system was paper-based, with hand-written responses on printed forms needing manual entry into an Access database.

These manual processes reduced visibility and accountability over the process. By using AssurX to automate these two processes alone, the company was able to free up 20 hours weekly in administrative work.

As a result of this early success, the company has since deployed a number of additional quality processes in AssurX, including:

• Deviation Tracking
• EHS Incident Management
• Complaint Management

Today, tasks and reminders are automated to keep processes on track, while the company also performs extensive analytics on quality data to identify trends and accelerate problem-solving.

5. Semiconductor Manufacturer Reduces Wafer Production Time from Months to Days

A semiconductor manufacturer using siloed systems to manage field service incidents needed to deploy an automated system for early data collection, failure reporting, analysis, and corrective actions (FRACAS). Maintenance, downtime, and privacy concerns were all top challenges the new system would need to address.

The manufacturer chose AssurX because of the vendor’s expertise in regulated industries, providing a system that supported HIPAA and SEMI E10 compliance along with easy workflow configurability.

Within the first two months of deploying the FRACAS system, the manufacturer fabricated more wafers in a single day than it had previously in an entire month. The system also allowed them to:

• Automate root cause analysis and CAPA for more effective issue management
• Collect accurate Reliability, Availability and Maintainability (RAM) metrics to ensure SEMI E10 compliance and customer confidence
• Capture detailed data around failures for deeper analysis and risk mitigation
• Maintain all data in a secure environment that protects against unauthorized access

 6. Toray Composite Materials America Digitizes 60+ Action Request Forms to Automate Workflows

Toray Composite Materials America (CMA), a manufacturer of advanced materials used in a variety of industries, was struggling with inefficiency related to paper-based nonconformance tracking. Challenges included time-consuming meetings, approvals, and data retrieval, plus an inability to effectively track issues.

Toray CMA chose AssurX due to its configurability, using the platform to create workflows for tracking issues from intake to root cause analysis to resolution. The organization has increased accountability over issues while reducing labor hours on manual processes, with the ability to configure workflows without changes to source code.

As a result of their initial success, today over a dozen departments in the company use AssurX, using over 60 active action request forms to automate processes such as:

• Complaint Management
• Deviations and non-compliance investigations
• Change Management
• Audit Management

7. Medical Device Manufacturer Eliminates 2,400 Labor Hours Annually with Automated Nonconformance Management

After tripling in size, a cardiovascular device manufacturer needed a better system to manage electronic and paper-based records of compliance data at U.S. and EU facilities. Analyzing reported problems was time-consuming, which resulted in delays throughout the quality chain.

The manufacturer initially deployed an automated compliance management system to manage CAPAs and external corrective action reports. Since then, they have also deployed automated process workflows for:

• Nonconformance Management
• Receiving and Inspection
• Complaint Management
• Electronic Medical Device Reporting (eMDR)

 By replacing manual processes with automated workflows, the company eliminated over 2,400 labor hours in nonconformance management alone, and can now generate and submit eMDR/MedWatch reports with just two clicks.

8. Vermont Electric Power Company Cuts Audit Preparation Time By More Than Half

Facing new electric utility regulations, Vermont Electric Power Company (VELCO) sought an automated solution to ensure compliance with 83 standards covering roughly 800 requirements. The utility needed a way to verify that required actions were completed to operate and maintain systems, and provide evidence of this work on a continuous basis.

VELCO implemented AssurX due to its versatility and industry-specific capabilities, allowing the company to store evidence, track tasks, and provide visibility across the organization.

As a result, the utility was able to reduce labor preparation hours from 24.5 hours to less than 11 hours per requirement. The organization was also able to automate the generation of Reliability Standards Audit Worksheets (RSAWs). After a demonstration of the utility’s initial controls to the Northwest Power Coordinating Council (NPCC), regulators reduced the organization’s next audit scope by nearly 50%.

Conclusion

Implementing an automated compliance management system is a significant effort requiring input and buy-in from a number of stakeholders. Engaging your team in the process is key, and those who put in the effort up front are more likely to reap bigger rewards in the long run.

For those who do—and those who are truly committed to using the system to drive continuous improvement—the results can more than pay for the initial investment. From reduced labor hours to greater efficiency, compliance, and accelerated issue management, the sky truly is the limit.

View all of our case studies to learn how AssurX has helped companies like yours revolutionize compliance management

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.