Event Brief: ComplianceQuest Inaugural User Conference
Axendia’s Sr. Industry Analyst, Sandra K. Rodriguez, was invited to attend the Inaugural ComplianceQuest User Conference, ConQuest, at the luxurious Vinoy Renaissance Resort in St. Petersburg, FL. 70 customers and 25 partners participated in the event from April 11 – 13, 2023.
Highlights of the event including product road map, vision, and user case studies featuring Janssen, Ocean Insight and FLEX, plus a panel discussion on the challenges for women leaders in quality and manufacturing are below.
Conference Keynote: You Asked, We Listened
After morning calisthenics and games to rev up the audience by Nikki Willet, chief strategy officer at ComplianceQuest, Prashanth Rajendran, CEO opened the event with, “We’ve been listening hard to what you’ve been asking for. As a result, engineering, manufacturing, quality and safety are now all together in one solution platform to provide a continuous feedback loop between product design and development, supply chain and customers.”
In addition to expanding its platform, ComplianceQuest significantly expanded its customer base over the past year. Notable new clients include the Centers for Disease Control, CPC Clinical, FLEX, Myonex and Verily. The company is also holding on to its title as a Salesforce Summit Partner and ranking in the top 21 of Salesforces’ 1500 ISV partners.
The Power of a Platform
Atulya Risal, chief operating and technology officer at ComplianceQuest expanded on Rajendran’s opening keynote address. “We are on a Quest to help navigate the narrow band between risk and productivity. Our vision is to bring engineering, quality and safety data together for a complete compliance and productivity platform that empowers your workforce and brings real data to front-line operational management.” ComplianceQuest is also focused on what it calls multichannel interaction – rather than bringing users into the system, it is aiming to bring the system to the users.
In its next release, v13, will have impressive capabilities including its own version of Salesforce CRM analytics for CQ related analytics. Users will be able to leverage new AI capabilities as well. For example, it can look at non-conformances in different languages such as Spanish, Chinese and English to determine if they are similar. Risal finished with demonstrating the use of generative AI whereby the technology wrote an investigation summary which Investigators can leverage for their final version, speeding up the process.
Janssens’s Next Generation Quality System
Aleshea Burnell, Director Quality System Applications and Stephen Vargo, Technology Product Manager at Janssen discussed their approach to delivering a next generation quality system to their organization. The back story was familiar – the company needed to replace a highly customized, outdated and end of life QMS. “Lengthy processes can delay release of products to patients. We didn’t want to just put in new software. We want to take our data and make informed decisions,” said Burnell.
From an IT standpoint, Vargo echoed Burnell’s sentiment and focused on how ComplianceQuest fits within the company’s digital ecosystem. “CQ SaaS is a foundation. We needed to move from a system of record and make it more of a system of engagement. We created our Next Gen vision in 2019 and today, technology is catching up with the vision. We are investing in SaaS… we don’t want to focus on servers that are out of date but rather on outcomes for patients,” added Vargo.
The Next Gen initiative focuses on three areas: intelligent automation, operational efficiency, and technical excellence. “We are ‘taking the robot out of the person’ and being intelligent about how we use our people. For example, AI is helping and enabling our employees with in-process work,” explained Burnell. The company seeks to have one hundred percent of its data integrated. By bringing quality and manufacturing data together, data scientists will spend less time sourcing data.
Ocean Insight Goes to Gemba
Gemba is a Japanese word meaning “the actual place.” In lean practices, the gemba refers to “the place where value is created,” such as the shop floor in manufacturing or the job site on a construction project. Five years ago, Ocean Insight was heavily relying on inefficient, paper-based processes for Quality and HSE. The first thing Ron Shah, Global VP of Operations, did upon joining the company in 2017, was seek an EQMS and HSE solution that would kick start the company’s digital transformation journey.
In late 2018, Shah selected the entire ComplianceQuest platform for QMS and EHS. “We didn’t want to eat the elephant; so, we started with doc control & training and took advantage of out-of-the-box process flows,” said Shah. His vision has enabled the company to shift from a reactive to a proactive mindset.
Today, the company has realized huge time savings and increased customer satisfaction. Through a vast array of KPIs, Shah explained what measures gets controlled including safety, quality, delivery, inventory, cost, etc. In as little as one year, Ocean Insight received its return on investment. Labor costs went down by $500K, customer returns were reduced by 75% and on time delivery rates improved by 8%.
Flex Rethinks QMS
Flex is the trusted global manufacturing partner of choice to a diverse customer base, helping design, build, and support products that improve the world. Garth Conrad VP of Quality, Health Solutions at Flex explained, “We have 170K employees globally, so we realized that whatever we put in place had to be useable and work in the environment we have including over 100 facilities and one thousand customers.” When the company originally built its quality system, it built two of everything because Flex operates in regulated and non-regulated environments.
Conrad noted when you add complexity to your operations, you also add cost. “I don’t want a CAPA tool. I want to know how to manage issues. We needed a solution that was going to be flexible enough for regulated and non-regulated environments. We looked at it from the digital thread standpoint. What can connect documents, training, CAPAs, etc.? We also didn’t want an audit, inspection, or complaints system. We needed one that links requirements, risk, assessment, issues, investigations, etc., then use that data to control, correct, prevent, verify, and report for performance monitoring.
Before rethinking QMS, Flex needed to rethink its business processes. Over 150 users were involved in the vendor/solution selection process. The team focused heavily on out of the box capabilities. ComplianceQuest QMS has c-suite approval, and it will be a One Flex solution with mandated use. The implementation team’s mantra is fast to fail, fast to correct, and meet medical requirements but do not overburden the rest of the organization. The decision was made to go with the most complex modules first – Documents and Training. “Once that information was migrated over to CQ, it was cut off immediately to avoid any issues with duplication… you don’t want those two systems running in parallel,” cautioned Conrad.
The implementation timeline is an aggressive one for Flex. Conrad’s team started with 3 pilot sites, then another 10 sites were identified as early adopters and the remaining mandated wave will go last. eQMS is scheduled to be completely rolled out in the next twelve months, and the remaining modules will need to be configured by that time. This will be the largest eQMS global deployment for ComplianceQuest.
Panel Discussion: The Challenges of Women Leaders in Quality and Manufacturing
There have been many exceptional women leaders in the fields of quality and manufacturing who have made significant contributions to their organizations and industries. Yet some women often face barriers to entry, advancement, and recognition. To address these challenges, women leaders from Janssen, Outset Medical and YKK offered their personal experiences and shared insights on how to encourage and motivate women to become leaders in quality and manufacturing. Some recommendations include:
- Apply! Women are 50% less likely than men to apply for a position if they don’t have 100% of the requirements outlined in a job description.
- Mentor junior associates – spend time with them and share knowledge so they have the right level of experience to apply for positions of increasing responsibility.
- With recognition comes motivation. It’s important to recognize the achievements of other women on the team.
- Offer both hard and soft skill training.
My biggest take-away from the panel discussion was that while today the playing field is fairly even when it comes to opportunities, the root cause of the lack of women in quality and manufacturing is that women are not applying for these positions. STEM degrees are being disproportionately pursued by men. In order for more women to pursue learning in STEM fields, there will need to be a concerted effort from individuals and organizations to create a more inclusive environment for all. As women, we’ve come along way but have much, much further to go.
ComplianceQuest’s inaugural user conference was filled with customers eager to network with their peers, understand the capabilities of the upcoming v13 and take advantage of the demo labs set up throughout the venue.
With point solutions being a thing of the past, ComplianceQuest’s new capabilities in V13 will empower customers to intelligently automate compliance operations with a unified PLM, QMS and EHS productivity platform embedded with risk-based thinking.
We will continue to provide updates on ComplianceQuest as they become available.
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