Transforming quality from one manager's problem to everyone's success

Who are Akadeum Life Sciences?
Ann Arbor, MI
Company size
Medical device/SaMD

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Akadeum Life Sciences makes isolation products leveraging the gentleness of buoyancy to capture chemical and biological targets.

Their innovative flotation-based microbubble technology isolates samples of cells, proteins, exosomes, nucleic acids and more with complete integrity and quality.

The company's products are classed as a medical device/biologic accessory, making FDA 21 CFR 820 and ISO 13485 compliance a key priority as the business expands.

The challenge

Quality Assurance Manager Angela Pinkston joined the Akadeum team in June 2022, just as the company was beginning to search for a better way to manage quality.

The early-stage company takes good manufacturing practice (GMP) and continuously improving quality seriously, but a paper- and spreadsheet-based QMS was demanding huge amounts of upkeep and admin time.

I've worked in companies using paper before.

It's possible to comply - but it's a lot of work and there aren't enough hours in the day.

— Angela Pinkston, Quality Assurance Manager, Akadeum Life Sciences

SOPs, forms and records were all manually managed by Angela in a process with lots of duplicated effort and 'hours' and 'days' of stress.

The solution

The Akadeum team had already begun scoping eQMS platforms as Angela joined, and had a frontrunner in mind.

Since Angela had previous eQMS experience from other roles, she was tasked with taking over the search.

An easy-to-use system with fast implementation was her main criterion after going up against other clunky platforms in the past:

With other eQMS systems, I almost felt like I should've taken classes in coding.

They were so convoluted and confusing - and making procedures to train other people how to use them was also difficult.

— Angela Pinkston, Quality Assurance Manager, Akadeum Life Sciences

Akadeum wanted a cloud-based and audit-ready platform which could go under the microscope of an FDA inspection.

After performing her own search of the market, Angela identified the same frontrunner as the rest of the team: Qualio.

Akadeum became Qualio customers shortly after, and Angela and the team were guided through a 'seamless' implementation and training process which completed in a 'phenomenal' 3 months.

The results

Akadeum's quality management was transformed by Qualio, from Angela's sole, stressful responsibility to an active, collaborative part of the company culture.

Angela estimates a 99% cut in quality admin time, freeing her up for the continuous improvement activity and problem-solving which she joined the company to do. 

'Angela's SOPs' are now owned and supported by everyone. All company documents, training records and suppliers are now digitally managed, with 99% of training completed on-time.

And the company now enjoys a real culture of quality that's made Angela's life '100% better'.


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