Say Hello to Dottie: Combining Quality, Compliance and Production Optimization with AI

Dot Compliance Briefing Note

Axendia was recently briefed by the executive team at Dot Compliance, on its newly released, ready-to-use AI-powered QMS. Headquartered in Phoenix, Arizona, Dot Compliance was founded in 2015 by Doron Sitbon. The company currently employs over 120 professionals across the world.

The company’s cloud eQMS, Xpress 5.0 is pre-configured with industry best practices and is a native application on the Salesforce platform. “The QMS space has been the same for many years.  We are finally seeing a shift wherein life science companies are implementing QMS to obtain actionable insights from big data and analytics, as opposed to merely replacing manual or paper-based processes,” explained Doron Sitbon, Founder and CEO of Dot Compliance. 

Dot Compliance’s AI-driven QMS is powered by Dottie AI to enable embedded generative and predictive artificial intelligence.  Dottie leverages OpenAI’s ChatGPT and proprietary algorithms.  With Dottie, quality processes and tasks are automated which in turn allows quality assurance professionals to focus on value-added work.

Is a QMS Really ‘Ready-to-Use’ if Clients Are Not Using It?

Dot Compliance offers a cloud-native, ready-to-use QMS solution that is pre-configured based on life science industry best practices and processes and includes sample SOPs and KPIs.  Its QMS supports 21 CFR part 11, Part 820, EU-Annex 11 ISO 9001, 13485, 14791, 27001 and is GDPR compliant.

The company reports over ninety percent of customers are using its QMS “As-Is” with no configuration or customization.  “For so many years I’ve heard the phrase ‘ready to use’ but is a system actually ready to use if no one wants to use what you’ve built? We’ve listened very carefully to our customers when it comes to what they need, what is working and what doesn’t work,” said Sitbon and continued, “our solution is specially engineered to allow us to provide what we call – knowledge in a box.”

Dot Compliance focuses on the SMB market where the headcount in a company could be as little as fifty employees.  “When we receive a call from a client, we actively look at whatever issue a client is having and make sure we address it so that they don’t have to call us again,” added Sitbon.  Because all clients are on the same instance, bug fixes and updates are pushed to all customers at once, which eliminates different organizations reporting the same issue and all are on the same version.  “Another major differentiator is that we include validation in our subscription model. Dot can offer a complete validation package because the system is ready to use. Validation has historically been a pain point for life science companies and we truly eliminate this pain point altogether” said Sitbon.

Mickey Landkof, GM and Global VP of Sales at Dot Compliance added, “we use what I call the AirBnB model – all you need to do is bring your clothes and personal items and start using the “house” right away. All of the rooms (representing business processes) are fully furnished but nothing is cemented to the ground so you can move things around if you really need to.”  The end result is a process of adoption, not a painful implementation and many customers have full use of their eQMS in as little as two weeks per Landkof.

Time to value is becoming increasingly important – perhaps even more so than software features and functions. Today, over eighty percent of the implementation team at Dot Compliance are professionals who came from the life sciences industry, with many being former clients. “Because our implementation team has been in the driver’s seat, has worn the quality hat at a company – and thinks quality rather than technology – we’re able to create value faster for our customers,” added Sitbon.

Image Source: Dot Compliance, Inc.

In keeping with the AirBnB example, Landkof explained, “When we do an implementation, we basically do a walkthrough of the house where everything is already setup from day one. Think of QMS Xpress as the first floor of a house.  We would look at something like Document Management [a room on the first floor] and why is it [the couch for example] located against the wall versus somewhere else in the room.  If adjustments are needed, we can easily make them and most times they have little to no impact on validation. The result is an implementation (or more accurately – an “adoption”) that takes a fraction of the time and consequently also a fraction of the cost, that it used to.”   

With Xpand (e.g., the second floor of the same house), Dot Compliance has built upon its core QMS functionality with cross organizational processes including Equipment Management, Electronic Batch Records (eBR), Clinical Trial Management (CTMS), Regulatory Affairs Management, and other processes geared towards Medical Device customers such as DHF, DMR, Design Control and more. The wide array of business processes offered all under one single roof offers customers a significant ROI, creates user experience unification and the ability to exchange data and information seamlessly.

In my opinion, this makes sense since most companies don’t need ‘just’ a QMS, they’re looking for a way to capture quality related data across the product lifecycle.  Software vendors who want to sell pure QMS will inevitably lose the platform wars.

Say Hello to Dottie AI

AI algorithms can analyze large volumes of data collected within a QMS to identify patterns, trends, and anomalies. This can help organizations detect quality issues, identify root causes, and make data-driven decisions.

Dot Compliance Dottie AI Xpress seamlessly integrates AI-driven quality management data into existing processes. The AI platform constantly learns – enhancing its performance over time and providing increasingly accurate insights and predictions.   Dottie AI was developed with three core capabilities in mind: text insights, predictive AI and production line optimization.

Image Source: Dot Compliance, Inc.

The nuts and bolts behind Dottie are proprietary and not available for public disclosure.   However, it currently leverages ChatGPT to provide answers for specific sets of data.  Noteworthy is that the AI is available for new and existing Dot Compliance clients, as well as competing AI QMS solutions.  “We want to provide the right people with the right context and drive the right action because insight without action is meaningless,” said Sitbon.

Image Source: Dot Compliance, Inc.

“Dottie AI has several pillars including Predictive AI, Generative AI, and Production Optimization suite of Machine Learning and Data Science capabilities, all focused on endless and challenging QMS use cases together with production floor operation optimization use cases,” said Yuval Nardi, Dot’s Chief Science Officer and continued “Dot’s AI Pipeline allows for (i) pre-processing of all QMS records as well as other data sources (ii) embedding of all relevant text data (iii) a private and secure semantic similarity search and (iv) a completion service powered by large language models (LLMs).”

Dottie AI will be able to offer insights that might be difficult or time-consuming for a human to uncover.

In Brief

Dot Compliance reports a triple-digit uptick in its customer base over the past two years and has added life science and QMS industry veterans to support its growing business.

Dot Compliance is a pioneer with its ready-to-use, AI-powered eQMS for life sciences with generative and predictive AI capabilities.  In addition to serving pharmaceutical, biotech and medical devices clients, Dot Compliance clients include pharmaceutical, medical device, medical cannabis, digital health, nutraceutical, CPG  and hospital laboratories.

We will continue to monitor Dot Compliance and provide updates as they become available.

Contact to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

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