DCI Donor Services eliminates paper-based quality management

The challenge

Before the Ideagen Quality Management implementation, DCI was handling its quality management system needs through a paper-based system.

Manual paper and server file-based systems can be time consuming, cumbersome and require extensive resources to maintain and manage. Kelly continued: "We used MS Excel for tracking purposes but also maintained everything in a paper log since Excel cannot be validated."

Kelly explained that the system was redundant and time consuming, citing issues including:

• Deviations and complaints were manually passed from approver to approver, resulting in increased turnaround times.
• Assets (equipment and instruments) had no electronic notification system in place, making the tracking system cumbersome and inefficient.
• Trending data was pulled and trended manually, requiring a higher number of resources and time.
   

The solution

Kelly explained that the Ideagen Quality Management implementation enhanced DCI's quality operations in many ways, including:

• Deviations and complaints: The electronic notification system is very clear, allowing administrators to see where the deviation is in the process. With specific target dates for each stage and action in a deviation workflow, automated messages for overdue items improve process efficiency.
• Assets: The notification system ensures the Asset Owner is aware of all upcoming requirements. Escalation messaging is helpful in notifying others if required asset activities become overdue.
• Document storage: Almost all DCI documents were paper based in the past and maintained on-site, both electronically on a network drive and in hard copy. With Ideagen Quality Management, office supply costs decreased, storage space for other critical items was freed up, and document access and revision security improved significantly.

When asked which parts of Ideagen Quality Management she was most excited about, she responded: "All of it! I am really looking forward to being able to run reports at the click of a button instead of manually compiling the data."

Pre-loaded reports and the ability to customize and create required reports to any specification is a highly sought-after aspect of the Ideagen Quality Management implementation

ECL2, an Ideagen company, works with more than 25 OPO facilities, allowing them to share best practices and others' successes in subsequent implementations. Additionally, all ECL2 professional service consultants have been previous quality managers and Ideagen Quality Management customers, giving them a unique and specialized perspective into implementation as well as being a valuable asset to the facility's quality program as a whole.

Additional services: validation

DCI also took advantage of ECL2's computerized system validation services. ECL2, an Ideagen company, developed custom validation documents specific to DCI's system configuration. Once developed, Kelly executed the protocols which gave her an intimate knowledge of all aspects of the program. Due to ECL2's validation expertise, Kelly was able to quickly validate and release the system for use. This saved a significant amount of time and resources which would have been required had she written these documents herself. The execution also reinforced Kelly's confidence in the configuration and confirmed that all of the user requirements had been met.

The results

By replacing a paper and spreadsheet-based quality system with Ideagen Quality Management, DCI Donor Services gained the efficiency and oversight needed to focus its team on its core purpose: saving and enhancing lives. Key outcomes include:

• Paper eliminated: Documents previously maintained on-site in hard copy and on network drives moved to a centralized, secure digital system.
• Faster deviation management: Automated notifications and target dates replaced manual approver-to-approver handoffs, cutting turnaround times.
• Smarter asset tracking: Electronic notifications keep asset owners informed of upcoming requirements, with escalation messaging for overdue activities.
• Reporting at the click of a button: Pre-loaded and customizable reports replaced manual data compilation, freeing up valuable staff resources.
• Validated and audit-ready: Custom validation documents gave the team full confidence in the system configuration and confirmed all user requirements were met.

By partnering with ECL2, an Ideagen company, DCI built a quality management foundation specifically configured to meet the demands of a highly regulated, life-saving organization.