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Alimentiv streamlines their quality processes with a configurable and compliant eQMS

Customer Story | Alimentiv

Success Highlights

Configurability without IT or CS support
Configured to their processes without IT help
Module expansion at no additional cost
Module expansion at no additional cost
21 CFR Part 11 compliance with full audit trails
21 CFR Part 11 compliance with full audit trails

Meeting an Immediate Need: Streamlining Critical to Quality Processes

Alimentiv’s story is one of continuous improvement. As a well-established CRO, they provide exceptional clinical research services to academic and industry customers. To consistently meet the needs of these customers, they acknowledged the importance of optimizing their quality processes to enhance overall operational efficiency. A Senior Quality Assurance Specialist at Alimentiv, explained, “We were tracking our CAPAs in Excel, and when using this program, large data sets tend to corrupt so that data is lost or moved around.”  

Not only can spreadsheet-based quality processes become difficult to manage, but they are also not 21 CFR Part 11/ Annex 11 compliant, meaning they don’t meet the necessary regulatory requirements to assure the security and accuracy of data. To address this immediate need for their QMS, Alimentiv started looking at electronic quality management systems (eQMS).

“What attracted us to ZenQMS was that it’s highly configurable.”

“What attracted us to ZenQMS was that it’s highly configurable,” said the Senior Quality Assurance Specialist. “Not all the systems we looked at were as configurable as ZenQMS and we saw the potential for expansion. We knew we wanted to use it for CAPAs, but it had other capabilities we could expand on in the future.”

Moving in the right direction: more modules, more capabilities!

Alimentiv’s Director of Quality Assurance saw the potential for expansion as well, specifically the need to improve and streamline quality processes and bring everything into a 21 CFR Part 11/ Annex 11-compliant eQMS. 

“We decided we needed an eQMS to house our critical-to-quality processes including Document, Training, and Issues management.”

Before expanding their ZenQMS instance, Alimentiv explored other eQMS solutions to compare prices, capabilities, and modules. Ultimately, they decided on ZenQMS as the best option for their eQMS needs. 

“The fact that we could use any of the modules without a per module cost increase was very helpful, especially as we continue to expand our usage of ZenQMS,” added the Senior Quality Assurance Specialist. Amid their expansive growth, Alimentiv continues to enhance operational and process efficiencies by integrating a configurable eQMS. 

“The fact that we could use any of the modules without a per module cost increase was very helpful.”


What does ‘Configurability’ really mean?

There is a lot of talk about configurable systems in the eQMS landscape, however, it essentially comes down to two things. The obvious one is, “How configurable is the system?” True configurability allows users to take the quality processes they’re familiar with (paper SOPs, Excel spreadsheets, etc.) and recreate them electronically, with the added benefit of permissions and automations built right in. “Out-of-the-box” eQMS platforms with rigid templates and pre-set menus are only half a solution.

The second, and arguably more important piece to configurability, as far as Alimentiv is concerned, is empowerment: Having the ability to make changes to CAPAs, deviations, and other issues as required without waiting for IT, the vendor, or a quality consultant. 

“We have the power to configure without assistance from ZenQMS support, allowing us to take control and rely less on external resources.”

“In preparation for our expansion, we realized that I needed to go into the system and evaluate our current workflow and any improvements that could be made,” indicated the Senior Quality Assurance Specialist. “The Issues module was configured by Alimentiv team members, and then Alimentiv met with ZenQMS support to review the initial configuration, which was invaluable. Now as System Administrators, we have the power to configure without assistance from ZenQMS support, allowing us to take control and rely less on external resources.”

In ZenQMS, administrators have the ability (with permission, of course) to take their manual spreadsheets and paper-based workflows and recreate them according to their preferences, without being locked into rigid pre-populated templates. 

For life science companies looking to continuously improve their processes, moving away from paper-based or non-compliant electronic systems is the first step. ZenQMS can help with a CFR Part11/ Annex 11-compliant, configurable quality system that empowers users and allows them to reimagine what they can accomplish inside an eQMS. We invite you to learn more.

Alimentiv logo squareAbout Alimentiv

Alimentiv is a global gastroenterology-focused contract research organization (CRO) providing clinical trials, central image management, precision medicine, statistics, and laboratory services to the pharmaceutical and biotechnology industries. Headquartered in London, Ontario, Alimentiv employs more than 500 people across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America. 

The organization’s unique model combines the efforts of internationally recognized academic researchers and operational experts to offer integrated solutions to customers. Over the past 20 years, Alimentiv has become a recognized expert in clinical trial design, central image management solutions, outcome measure development, and precision medicine for drug development in GI. Today, Alimentiv provides services in more than 50 countries worldwide, collaborates with leading universities and academic institutions across the globe, and works with many leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients. 

Alimentiv is committed to investment in medical research and development, focusing on identifying barriers to drug development and pursuing solutions that advance GI research. The research findings are operationalized into an efficient clinical trial methodology for clients that aligns with emerging regulatory standards. In collaboration with leading experts, Alimentiv has pioneered the development, validation, and standardization of outcome measures and technology, shaping the evolving clinical trial landscape for multiple indications and providing meaningful long-term consequences for patients, their treatment, and society.

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