Customers Share Their Quality Management System Metrics

Saying that something will get better isn't a very specific or convincing promise. Saying it'll improve by 90% based on real-world evidence is much more enticing. Concrete metrics paint a more accurate picture of how helpful an electronic quality management system (eQMS) is. That's why we spoke to our customers and compiled quality management system metrics to demonstrate how MasterControl can work in your organization.

Document Control

Document control in regulatory environments is the key to approving standard operating procedures (SOPs), passing audits, and getting regulatory approval. FDA Form 483s and warning letters are filled with references to missing/inadequate/incomplete procedures. Getting everything in order, and keeping it in order, is a full-time job. For one company, it was actually three full-time jobs. That changed after implementing MasterControl.

“It took three people to manage change control and document approval cycles…in a paper-based, manual environment,” said a global document management coordinator at the clinical development firm Bioclinica. “With MasterControl it now only takes one person to efficiently manage those documents.”

Not only does MasterControl help employees be more efficient, it makes processes more efficient. Fagron North America Quality Specialist Matt Seitz-Paquette noted that before MasterControl, creating and approving a quality document took a month. Now with an eQMS they can create and approve 30 documents in a month.

Training Management

Some of those documents that life sciences companies need to show regulators include training records. Better document control helps with tracking down the records, but employees need to be effectively trained in the first place. Effective training and tracking who has been trained are automated in MasterControl.

When UCSF Health began using MasterControl, their training improved dramatically. “Using spreadsheets and email to manually gather and track…employee signatures for training…was extremely time intensive and prone for errors,” said Clinical Analyst Joanne Foster. “With MasterControl, we've improved our training cycles by over 50%.”

Another quality management system metric related to training comes from Fagron, which saves over 450 hours annually now that they use MasterControl for training. Seitz-Paquette noted that this time was needed for printing, binding, and preparing training binders. With everything digitized, this is no longer needed. Not only does the company save time, he also estimated they've saved 15,000 sheets of paper at each Fagron site.

Fewer Errors

In regulated industries, there's no room for error. Unfortunately, errors still happen. That's especially true when dealing with paper. The person writing the record may make a mistake and handwriting can be difficult to decipher. Digitizing with an eQMS makes those errors a thing of the past, especially if proper controls are put in place.

Using an eQMS enables you to remove variation in date fields, put limits on numeric fields, and otherwise control what can be put into a record. Cochlear Americas Director of Quality Systems Tom Pavlik saw these benefits as a way to comply with good documentation practices (GDP).

“The fundamental problem with a paper system is that it's prone to human errors,” Pavlik said. “When we went digital, everything became more efficient, not just because there wasn't this transfer of time from paper to paper but because people could fill in a pre-determined form.”

Wellington Foods, a contract manufacturer of dietary supplements, saw data entry errors plummet after using multiple MasterControl solutions. They reduced data entry errors by 90%-100%.

Conclusion

Our customers bring life-changing products to market, and we want to make sure they have the tools they need to do this as efficiently as possible. In regulated industries, quality management is a big part of ensuring those products are safe and effective. We're proud to partner with our customers to reach positive improvements in their quality management system metrics. Our customers have made more improvements than those mentioned above. To learn more, download our customer spotlight here.