You Can’t Spell Quality Without IT

Quality and IT are usually kept separate in the corporate world—or considered two different beasts. But in his interview with Shelly LaPointe, senior manager of IT, Quality, Regulatory and Clinical Affairs, at Thermo Fisher Scientific, Quality Digest CEO, Jeff Dewar, discovers a different relationship emerging. One of multiple interviews conducted during MasterControl’s Masters Summit, which boasted approximately 1,000 attendees and multiple speakers within the manufacturing, life sciences, and tech industries, Dewar’s conversation with LaPointe reveals insights into how IT professionals and quality management can work together to create a more cohesive and skillful workforce.

LaPointe, who took a leadership position at Thermo Fisher in 2018, is no stranger to the world of compliance and regulatory standards. However, her shift to working with such a large company came with unexpected challenges. For one, scope: Thermo Fisher, by her description, is enormous—and growing constantly.

“I think when I started they were around 70,000 employees. Now, we’re over 120,000 employees, so a huge footprint really, in all aspects of science,” says LaPointe.

The reason behind this astronomical growth? Company acquisition. And with that comes the acceptance of, and adaption to, various systems.

“That’s where my team in corporate IT comes in,” says LaPointe.

Pros and cons

Merging with companies brings the experience, knowledge, and technical abilities of people from numerous backgrounds and lines of work. As LaPointe says, things “get interesting.”

And with more than 200 manufacturing sites comes the expectation to manage these units and divisions with some sense of unity while keeping the quality systems that have worked prior, to whatever extent possible.

Her team, ITQARC, handles this as part of three divisions: the Quality Technologies Team, a Computer System Validation Group, and a Quality Assurance Group to handle both audits and supplier qualifications.

Departing from a more traditional quality management route means that while quality remains at the forefront, the skills that come from managing systems within IT bring added value to the organization. LaPointe says employees are constantly “learning from each other, and... developing a strong pillar.”

As part of standard business practices, LaPointe maintains that the quality organizations within companies acquired via mergers retain their governing structure. However, her team does help them home in on the most effective and efficient ways to handle regulatory procedures and improve quality control.

“We generally don’t come in and impart a change in governance at that kind of operational scale,” she says. “So, really, each business unit was contiguous within itself, with its own quality unit, and IT was the one that needed to kind of graduate and have a quality function within it.”

She is in a unique position as a leader of two areas—IT and quality—that, while not opposing, have different goals and purposes.

“It’s a real challenge, the nomenclature,” she says, as the group works under an arch of IT. “And it’s a big learning curve. We have to have that backbone of support from corporate, quality, and regulatory, so we can be sure we’re not just preaching to the choir—that we’re making sure it’s actual compliance, not just IT.”

In this clip, LaPoint describes how IT and QA work together. View the entire interview here.

GXP, validation, and IT, oh my!

Thermo Fisher is the first company, to LaPoint’s knowledge, to have a team that is primarily an IT department dedicated to quality.

She says having experienced technically minded professionals—whether they have GXP expertise or pharmaceutical backgrounds—who are able to create new systems and do validation work makes their job easier.

“We can kind of leverage, you know, folks that have been doing this for a long time in various other forays, and now impart that same kind of mindset into organization and really create some good policies.”

Building upon the knowledge, talent, and decision-making of people from various backgrounds and acquired companies has strengthened the IT department and its commitment to quality. Ultimately, while they begin with multiple systems, their job is keep a finger on the pulse to provide aspects of quality improvement and assurance work.

Quality management systems within Thermo Fisher are up to more than 200 since LaPointe took her position, simply due to company expansion.

Ensuring that these fit into one of their quality platform standards is a major part of what she does, and that includes taking what works from any organization acquired, whether it’s an additional standard or a validated learning management system (LMS), as was the case in the merger with Patheon.

And then, after all is said and done, the team eliminates waste and redundancies.

A changing focus

Therein lies the difficult process of accepting acquired quality systems, shifting the focus to IT wherever possible and narrowing down the most effective and efficient systems for companywide usage.

Finding something that is “supported at the enterprise IT level,” as LaPointe says, isn't easy but remains the ultimate goal for her team as they weigh the pros and cons of various systems.

It’s vital, says LaPointe, to keep every professional’s opinion and expertise in the conversation, from system validation to the legal team, so they can fulfill their quality goals within IT, no matter how they got there—be it via typical hiring processes or company acquisitions.

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