ANALOGIC

The Challenge:

NAVIGATING COMPLIANCE AND COMPLEXITY IN THE MEDICAL DEVICES INDUSTRY LEAVES NO ROOM FOR ERROR

In life sciences, medical devices, aerospace and other industries where lives, safety or critical infrastructure are on the line, there’s no room for error. Companies are held to the highest standards for quality and compliance, and meeting those requirements can be difficult amid evolving regulations, shifting market dynamics and global headwinds. 

Analogic’s Canada division is under constant pressure to meet the medical device sector’s most rigorous standards for its digital mammography solutions. 

As regulatory requirements became more complex in many countries, validation became more and more challenging, shared Anne Legros, Director of Quality at Analogic Canada. “We have to prove that we are doing proper validation. Documentation-wise, it’s more and more demanding.”

Analogic’s challenges extended beyond compliance. The team was also under constant pressure to do more with less. “We have a lot of pressure from our customers to reduce prices,” explained Daniel Drouin, Head of Quality at Analogic Canada. “Efficiency is very, very important – efficiency in building the product but also efficiency in managing documentation. This means time and effort.”

Leadership began looking for a quality management solution that could deliver traceability, automation and integration without compromising compliance. “We needed to know what was done by whom, when and how. If there is a recall, we need to retrieve that information quickly and easily,” shared Drouin.

The Solution:

ANALOGIC DIGITIZES QUALITY AND ACHIEVES A SINGLE SOURCE OF TRUTH WITH QAD EQMS

Analogic implemented QAD EQMS in 2007 and has trusted in the solution to deliver a single source of truth for its quality operations ever since. 

The decision paid off quickly by enabling Analogic to become an early adopter of electronic approvals, which eliminated paper from clean room environments and advanced its quality initiatives. “The amount of paper is not compatible with a particle-free environment. That was one of the advantages of implementing QAD EQMS at the time,” explained Legros.

The company’s use of QAD EQMS has expanded over the years and it relies on capabilities such as APQP (Advanced Product Quality Planning), Auditing, Inspection and SPC (Statistical Process Control), Document Control, Gauge Management, Training Management,  NCR/CAPA and Supplier Management to adhere to quality standards, track corrective actions and support continuous quality improvement.

“We’ve been using QAD EQMS for most of the processes that we have in the company,” said Drouin. Built-in workflows enforce proper process execution, guiding users step-by-step, and this structured approach has significantly reduced review times. “We used to spend 40 to 50 minutes reviewing documentation after the clean room,” continued Drouin. “Now they spend five minutes doing the same thing.”

Analogic’s team values QAD EQMS, and audits have never been easier. “Our auditor really enjoys seeing everything all centralized in one tool,” said Drouin. “When they ask, ‘Could I see this – is it in QAD EQMS?,’ it raises the confidence level.” 

Legros added, “With a single software application, we’re able to show customers and quality auditors everything from training records and documentation control to nonconformities and engineering changes.”

As Analogic’s needs grew and changed, leadership decided to upgrade to the latest version of QAD EQMS. The upgraded solution has brought even greater visibility to the company’s quality initiatives while also supporting remote collaboration. 

“The tendency is to have remote audits,” explained Legros. “So it's very convenient that we can be audited by teams in Europe or the U.S. Likewise, we use the system to audit our own suppliers by leveraging the audit results and the nonconformity module.”

The Benefits:

QAD EQMS BRINGS CENTRALIZED DATA AND CONFIDENT DECISION-MAKING TO ANALOGIC

“QAD EQMS gives our quality team the ability to dig into the data and be confident that every requirement has been met,” said Drouin. “With this tool, trust comes faster than it did in the past.”

Reliable access to centralized, electronic data has been transformational for Analogic. By digitizing records and consolidating them into an integrated system, the team has eliminated the need for paper-based, error-prone manual processes or searching across disjointed tools. “Now the system brings the information to them,” continued Drouin. 

“If something’s missing, it shows up – they don’t need to go searching for it.” With quick, accurate access to information, teams can work more efficiently, make decisions faster and take a proactive approach to potential issues.

Training, meanwhile, has become easier and more consistent across the organization. Onboarding new users is also easy given the unified nature of QAD EQMS. “The software guides people through the process. The end result is fewer problems—and less time spent resolving them,” explained Drouin.

QAD EQMS has benefited Analogic in many other ways, shared Legros. The solution supports the organization’s sustainability initiatives by reducing the need for travel and eliminating paper from many processes. “That helps us demonstrate a lower carbon footprint, which is increasingly important.”

The solution has also improved end-to-end traceability and control across the production lifecycle. QAD EQMS supports critical quality planning for new product introduction as well as the operational quality tracking for day-to-day production.

“It’s very easy for us to retrieve all the proof that the product was tested against specification. We have validation and verification reports, protocols—everything is easy to retrieve,” explained Legros. 

The relationship with QAD is very important to Legros, Drouin and everyone at Analogic. QAD Product Management always responds quickly, and “the collaboration has been very beneficial,” said Legros. “QAD has developed a deeper understanding of what’s required in the medical device industry – and we’ve learned in parallel.”