Pendulum Therapeutics Customer Story

Pendulum use Scilife to supercharge operational efficiency

Picture of Pendulum's product, a glucose control medical probiotic. Scilife’s Customer Story.

Pendulum's medical probiotic designed for the dietary management of type 2 diabetes | Source: Pendulum's website

Pendulum™ is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. They are researching, developing and commercializing a novel class of rationally-designed Live SynbioticsTM (probiotics + prebiotics) that have demonstrated clinical efficacy to treat conditions like metabolic syndrome, inflammation and neurodegeneration. Pendulum™ has created proprietary pipelines to build a unique discovery platform that identifies key, novel bacterial strains and the prebiotics that feed them. Since the product has its commercial presence in USA, the company is expected to meet current Good Manufacturing Practices (cGMP), Hazard analysis and Risk based preventive controls for human food mentioned in 21 CFR Part 117. Pendulum opted for Scilife solution where they could maintain the change controls, standard operating procedures and other documents in one place from where they could be easily edited, revised with a proper audit trail.

Our Customer Success Manager Trine Michelsen spoke with Achal Deo, Director of Quality and Regulatory at Pendulum. During the talk, we discovered many ways in which Scilife was proving helpful to manufacture Pendulum’s rationally-designed Live SynbioticsTM.

Why Scilife

When asked about choosing Scilife over a number of other solutions in the market, Achal mentioned several reasons as follows:

1. The number one factor e-QMS

The number one thing which was the driving factor for choosing Scilife was that it was an e-QMS. Achal described to us that before opting for Scilife Pendulum had a hybrid Quality Management System, where in nothing was paper based, the documents were being signed by DocuSign but the process was quite ‘painful’ as it did involve some manual work for keeping version numbers, revisions and following up with people for approving a change.

2. The key thing: All in one e-QMS solution

Achal mentioned that “the key things that really stood out to us was that Scilife had all the modules that Pendulum needed. Making it an all in one e-QMS platform”

3. A Startup friendly configurable system

Achal also likes the openness of the system with which certain modules can be configured so that they are well suited for the process. As a startup this was super important for Pendulum because a startup needs to evolve fast as per changing expectations, unlike a company with a 20 year old legacy product in the market.

4. The Onboarding Support

One more aspect which helped Pendulum in decision making process was the Onboarding support given by the Scilife team. Initially Achal had a very small team consisting of only two team members, which included herself and her Quality specialist. Therefore without external support the mammoth task of transitioning from one system to another looked very challenging.

Therefore, Scilife's onboarding support proved to be really useful to offload the transition effort.

5. The Perfect Training Solution for Quality

Training process is very critical in a startup, especially because startup employees have to wear so many different hats and thus constantly need to be trained for different job roles. Also when a startup gets into the growth phase, there are an increasing number of new hires every month. In such a scenario Scilife’s Training module automates the training process really quickly. Allowing to automatically assign and track trainings based on job roles. One interesting aspect which Achal mentions is that Scilife is also being used as a nice introduction to ‘ Quality Training’ as every aspect related to Quality Management System can be demonstrated very well in Scilife. This has tremendously helped new employees quickly get trained on all the aspects related to quality management. They can clearly visualize the change management process through proper risk assessment and the workflow that makes change stick. This helps the new trainees appreciate that the quality management processes are there to make their lives easier and also to provide safe products to the user.

This is especially useful to build a culture where people know that they are not using a Quality Management System to meet the regulatory requirements but to understand why they do what they do.

It is an important reminder of the fact that as a manufacturer or a producer of a product, ultimately, it's your responsibility to ensure that what people are getting is safe and effective.

Adaptability to Scilife

We asked Achal how much time the Pendulum team spent on getting familiar with the system. Her response indicated that users showed appreciable progress from getting familiar to getting proficient.

Proficiency Level	Time Duration
Familiar with Navigation	2 weeks
Familiar with Process of initiating Deviation	4 weeks
Fully Proficient	8 weeks

Having been involved in the procurement process, Achal and her team was quicker to adapt to the new e-QMS system but it did not take very long for the production team to get used to the new system too. Achal thinks that the Dashboard feature in Scilife is very user friendly and it contributed largely to the quick adaptation to the tool. Dashboard sorts out the biggest ‘To Do’ items that the user needs to work on. The feature makes it very easy to pull out the in-progress QMS actions for the responsible user.

Achal also goes on to describe the strategy adopted by her to onboard the teams on Scilife. Achal made it a point to remove everything from the drive where the earlier ‘hybrid QMS’ existed and trained everybody using the recorded Scilife training sessions to familiarize users with the new system. It helped them avoid falling back to older ways of doing things.

"We have been using Scilife's Events Module to monitor the quality metric KPI's closely. It has enabled us to narrow down the root causes for several deviations with an ultimate benefit of improving quality and reducing costs."

Achal Deo

Director of Quality and Regulatory at Pendulum

Key Advantages of Scilife

When asked about key advantages of Scilife that Pendulum experienced, we understood the main areas where Scilife was helpful as follows:

1. Document Master List

This is essentially the Document List feature in the Document Control Module. The feature helps users search through a list of documents using keywords, document type, document date etc. Achal mentions that the feature was quite handy for the production team to search and access the needed documents.

2. Fast track Document Completion

Achal mentioned that the new system helped her a lot to create or add document templates (Document Types) , auto-assign the version number, initiate CAPAs and Change Controls for associated document versions with greater ease.

3. The Single Source of Truth

Scilife is a complete QMS package that contains all essentials that serve as a single source of truth during inspection.

4. Value for Money

As a start-up value for money was a crucial deciding factor for Pendulum. Scilife was a great choice in this regard as it contained all the necessary features to align processes, train and essential QMS elements supported by different Modules.

5. Ease of Implementation

Achal had previous experience of implementing an e-QMS solution when she was working at FDA. When she recollects her earlier experience of working with Scilife’s direct competitor, she says that the implementation was far more efficient in case of Scilife. She attributes it to the additional support extended by Scilife during the implementation process. The onboarding support enabled her to carry out the implementation single handedly, it also saved the executive team’s effort in allocating additional resources for the implementation process. She was only required to fill up a form with document names and share the data. Everything else was taken care of by Scilife™ onboarding support.

6. Compliance

Achal also sees Scilife as the greatest enabler for facing FDA audits at Pendulum. She sees it as a tool for moving from person dependence to system dependence. FDA can access everything that is needed for an inspection without having to depend on one individual. So far Scilife has been a great companion in facing third-party audits at Pendulum as all the evidences are present in a single source.

7. Production Friendly

The production teams generally find it difficult to relate with how the QMS elements interact with each other to assure quality. Achal observes that Scilife has made it very easy for the production teams to visualize how an SOP document relates with a deviation and so on. As a result production teams are taking initiative to dig deeper to find out which document says what.

8. Centralized System

Scilife was useful to implement centralized Quality Management Processes in the new site locations too. The group feature was useful in segregating the applicable documents for employees working on different objectives at different sites.

One Favorite Feature

When asked about one favorite feature, Achal says she likes the Change Control Module most. Because this module helps her tie up everything that is needed to implement a change in one place. For example, if there is a change in raw material specifications, then it can be easily linked to the change management SOP, all relevant documents and supplier qualifications to implement the change.

Quality improvements lead to Reduced Costs

When asked about direct impact on revenue, Achal shares that they have been using Scilife Events Module to monitor the quality KPI metrics closely. It has enabled the Pendulum team to narrow down the root causes for several deviations with an ultimate benefit of reduced costs thanks to improving quality.

Peer Advice

Achal has some valuable advice to peers who are looking for an e-QMS system:

1. Know what you want

2. Choose something which will grow with you

3. Evaluate if it meets your needs right now

4. Evaluate if it will meet your needs in the future

5. Do not over-complicate it into a system that nobody can use

6. Evaluate your resource availability

7. Evaluate if it aligns with your product and processes

8. Evaluate if you need a pre-validated solution

Conclusion

Pendulum is making best use of Scilife to improve quality, increase productivity and efficiency. The Pendulum team finds Scilife to be an ideal companion to scale up in coming years.

The onboarding team support, validation package, simplicity and user friendliness are the key differentiating factors from our direct competitors. We look forward to catering Pendulum with new quality by design R&D solutions apart from e-QMS and also wish them good luck to scale up their operations rapidly!