Pendulum's medical probiotic designed for the dietary management of type 2 diabetes | Source: Pendulum's website
Pendulum's medical probiotic designed for the dietary management of type 2 diabetes | Source: Pendulum's website
Pendulum Therapeutics manufactures probiotics as a food ingredient as well as for dietary supplements. As a team of scientists, doctors and innovators, Pendulum is passionate about finding revolutionary, safe, and effective solutions to ailments linked to gut health. From their San Francisco headquarters, Pendulum has a simple mission: improve the lives of millions through microbiome products.
With such a mission and so much at stake, Pendulum needs the highest level of Quality Assurance. As well as having QA professionals with great experience and knowledge, this also means having the right Quality Management System. To find out how Scilife has benefited Pendulum, our Customer Success Representative, Fabiola Samueli talked with Quality Manager, Lisa Huang, and QA Specialist, Cianna Sera.
When Pendulum first started out, they were using Google docs, Google drive and docusign for their QA workflows and processes. As Quality Manager, Lisa Huang explained why they needed to change:
“We needed a more centralized location and controlled space to share CAPA change, request training and documents.”
So, they searched for different eQMS solutions that met their Quality and budgetary requirements. And for the last four years, Pendulum has been using Scilife.
At the time of setting up with Scilife, the QA team at Pendulum only had a handful of documents to transfer into the new, digital platform, so it was fairly easy. As QA Specialist, Cianna Senna outlined how they implemented Scilife:
“It was pretty user-friendly in that we're able to use Microsoft Word. We would just transfer our documents, copy and paste them from what was our Google document into a Microsoft Word document and save right into the Scilife system, so it was a really nice, easy transition for us.”
Apart from the smooth transition, Cianna also appreciated the support the QA team received from Scilife:
“From the beginning, the team at Scilife has stayed connected with us pretty much through everything. When we have tickets, customer support is very communicative about what that ticket is and what the status is, which is very nice.”
Cianna also commented that onboarding training videos were very useful as it walked her through every single module. Lisa added to this:
“The other thing is the Knowledge Base documents. Those are very helpful when it comes to looking for quick, troubleshooting help when you don't actually need to submit a ticket.”
With the initial setup so smooth, and with Pendulum using Scilife for four years, we wanted to know what their favorite features were. The first thing that Cianna mentioned was the user-friendly search function:
“It's very search friendly within documents. With all our changes that are occurring in such a fast-paced environment that we have here, we have a lot going on. So being able to search for something in the search bar makes it really, really easy and more efficient for us.”
Cianna went on to provide an example with document control, explaining how being able to obtain electronic signatures and ensure there is version control helped them maintain 21 CFR compliance.
Another feature that Cianna really appreciated was how all documents are connected in a centralized system.
“With Change Control, for example, you can see all the version history. And you can see the audit trail if anyone has any comments. It's all in that one location, which makes it really easy for us to go find an older version if we need to reference it.”
For Lisa, one of her favorite functions is the approval workflow, especially in the change request module, because you can assign multiple approvers.
“Different departments can all look at it at the same time and we just have to send them a link, so we can sign it all at the same time.”
This means that the QA team doesn't have to spend time hunting down each person to sign every document. The flexibility of adding approvers and reviewers has also been beneficial to Pendulum, as their team grew.
“When we were a smaller company, we didn't have enough people for every single role in the workflow. We were able to customize it based on our needs and as we grow the team, we're able to add more people. So, it's really nice that Scilife has grown with us.”
Would the QA team at Pendulum recommend Scilife to other Life Science companies? Both Lisa and Cianna said they absolutely would. Cianna gave her reason:
“I think that the onboarding and the relationship with the Scilife team will be valuable to any QA team. The eQMS will help automate existing processes, optimize time and just overall boost efficiency like it has with us.”
And what advice would Pendulum’s Quality Manager give to other organizations when they are looking for a new eQMS solution? Lisa provided her answer:
“I would say create a road map for implementation and then get input from all the departments that would be interfacing with the software. Then create a matrix of levels of importance on what you really need versus what's nice to have and rank them and then determine if the software is capable of meeting your needs.”
So Lisa and Cianna have their favorite Scilife features and they would definitely recommend the eQMS to other companies. But what results have they achieved by using Scilife? Cianna went first:
“Scilife has definitely helped improve our communication and collaboration within our quality team and between other departments as well.”
The example she gave was when the team at Pendulum had a process change and they used Change Control Management:
“We're able to capture all the details within that change management and within that change control and communicate it really clearly, really effectively to our department and to any of the departments that are affected.”
Lisa echoed Cianna’s thoughts, adding that the Document Control module is also really helpful for collaboration because you can have multiple verifiers, approvers, and reviewers. As Lisa outlined, everyone can work together in one workflow, signing that documents have been verified, approved, or reviewed.
“It reduces the time to get documents published. Instead of having to hunt down each person, especially since some people are working remotely, we're just able to let them know that we have a couple of documents in the queue, ready for them to sign.”
And with all those documents approved in a timely manner, enables Pendulum to launch products faster.
Is your Life Science organization looking for an eQMS that ensures compliance, increases efficiency, and promotes collaboration?
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
