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As part of continuous improvement efforts, Coty determined that its filling process was generating a higher level of waste than expected. This was due in part to some lines overfilling containers to ensure aesthetic fills were met, which led to higher expenses on supplies. Considering the price of some of the fill liquids, this realization provided a significant opportunity to reduce overfill and save money. However, the company did not have enough historical data on the lines that were overfilling to understand the entire problem. This meant that process engineers and quality professionals did not have sufficient information to develop a viable solution. The manufacturing team at Coty’s Sanford, North Carolina, manufacturing facility turned to Statistical Process Control (SPC) analysis to better understand scrap at the point of manufacture on its filling lines. As part of its SPC Fill Height Project, Coty wanted to determine ways to reduce liquid scrap and better understand its process capability.

For Strategic Materials, quality was a primary measure of success, but sharing quality data between plants was a significant challenge. Each plant collected information using its own methods and nomenclature, leading to disparate data that was exported into Excel spreadsheets. This made cross-site comparisons nearly impossible. Brad Bell, Director of Quality & Continuous Improvement, needed a quality system that could quickly and easily unite data from all plants.

King & Prince Seafood faced the challenge of ensuring high-quality raw materials and finished products across their extensive global supply chain. With raw materials representing 60-75% of a finished seafood product, the company needed a robust system to manage and standardize quality data from various suppliers. The variability in raw materials and the need for real-time data visibility to spot trends and correct issues before materials were shipped to the U.S. were significant challenges. Additionally, King & Prince needed to digitize their manufacturing processes to view quality data from all points of origin in one centralized database, enabling them to make informed business decisions and maintain high standards of quality.

Until early 2020, Bakery on Main captured quality data on paper, making it challenging to respond to production issues promptly. The company needed a solution to view data in real-time and prevent production issues that could drive down revenue. They sought a cloud-based, digital quality solution to improve visibility and accountability, enabling them to detect and address quality issues as they happened.

As the company continued to grow and acquire more product brands, General Cable saw the need for consistent production data analytics across its global manufacturing base. Although the company continued to produce high-quality products, it wanted to implement a system that improved the ability to control process variation from plant to plant. With a standard approach to data collection and analysis, the company could ensure high quality, control raw material use, and prevent operational inefficiencies associated with rework, giveaway, production delays, or customer complaints.

As pharmaceutical and biotech companies scale, there eventually comes a time when managing processes like documentation using paper-based, home-grown systems becomes impossible. This is precisely the position Linical found itself in a few years ago when it merged with fellow CRO Accelovance to grow its global footprint.

As a smaller operation, IRISYS relied on a paper-based system where everything—including all SOPs—were printed out and signed by hand. Eventually, these documents would be scanned and put on a shared network drive. But it was still a manual process that took a lot of time. While this system worked well enough for a company with a handful of staffers, IRISYS started to scale rapidly. Between 2014 and 2017, the company expanded from 10 to around 50 full-time employees. With this growth came a lot more research and a lot more documentation.

Cirris had been relying on a number of home-grown software solutions to manage their operations and ensure regulatory compliance. These programs were developed by the company’s founder, who wanted to keep costs down. While these programs worked well enough for several years, Cirris eventually found itself running into problems with certifications because they were having a hard time tracking documentation changes over time.

As an early-growth-stage startup, ArcScan was relying on its contract manufacturer’s quality system for many years. As sales started to take off, the ArcScan team became frustrated with that system because it was paper-based and inefficient.

Due to the speed at which the company needs to operate and the high stakes that come with treating hospital patients, iMIX needed a robust enterprise quality management system (eQMS) to ensure that every product it shipped met the highest quality standards. Not only would the right eQMS system protect the company against liabilities, it would also make it easier to pass audits, which are conducted regularly by Medsafe, New Zealand’s FDA-like regulatory agency. To meet its goals, iMIX needs to balance its commitment to high quality standards with the ability to operate with agility.

For five years, CGX had been selling its products to researchers at universities exclusively. The company then decided to also start selling its products into the medical market, which meant they would have to adhere to a whole new slate of requirements. CGX had been using an offline QMS that 'got the job done.' But it wasn’t something the young company thought could grow alongside it. The system, for example, didn’t support working from home. 'It was creating a lot of roadblocks for us and slowing down development,' Linton says. Seeking a better way forward, the CGX team began looking for an eQMS.

To sell their medical device software to healthcare customers, Proscia needed a quality management system that would enable them to enforce high quality standards to ensure compliance with all relevant regulations. Since they wanted to sell their product internationally, the company needed a solution that would help them achieve MDSAP certification thereby ensuring compliance with FDA and ISO regulations and allowing them to sell to organizations in Australia, Brazil, Canada, Japan, the European Union, and the United States.

In 2005, Benoit founded a life sciences company called Enzymatics, which has since been acquired by QIAGEN. After an early customer sent over an 18-page supplier evaluation form and asked for a site visit to further explore their products and processes, Benoit realized the company needed to rapidly implement a robust quality management system. At the time, electronic QMS systems were rare, not user-friendly, and costly, so the Enzymatics team established a paper-based system—a decision that turned into a learning experience. Seeking to avoid a similar problem in his new venture, the Alphazyme business plan called for a paperless, ISO 13845-compliant quality system architecture from the get-go.

At a very high level, Sidekick has two different kinds of products: those that are regulated and those that are not. For example, a program designed to help patients manage diabetes effectively by telling them to go for a walk and eat healthier isn’t considered a medical device. On the other hand, apps designed to treat patients with chronic heart failure and peripheral artery disease are classified as medical devices. Recently, Sidekick decided to increase the number of products in their portfolio that required a CE mark. Lacking a purpose-built electronic quality management system (eQMS), the Sidekick team saw that they would need to fill out a ton of paperwork and create a lot of documentation over and over again with each new product. Sidekick had been using another software to maintain and manage all documentation. While the platform might have done the job well enough at a smaller scale, the company was looking for a long-term solution that could keep pace with their growth.

As the pandemic began shutting down the world, The Dot experienced an increase in the mission-critical nature of the organization. Several key healthcare and medical device clients began enlisting the company’s services to help secure their supply chains and ensure they could continue bringing life-saving products to market. To give these clients peace of mind, The Dot needed a quality management solution that would give customers visibility into their manufacturing processes so they could determine whether the CMO’s approach to quality met their standards.

NeuFit relied on a manual paper- and Dropbox-based system to manage their quality activities. Documents required a cumbersome approach of downloading, editing, and passing to DocuSign for every edit. Key document updates were easily forgotten, and searching for information in multiple logs and filing cabinets became overwhelming. Director of Operations & Quality Management Ami Anderson spent 'every day, all day, and a lot of overtime thrown in' just completing quality admin tasks. Since her team of 2 were paid hourly and Ami was salaried, she would be first in line for after-hours work if things didn't get done. This excessive quality timesink meant the other half of her role – operations – didn’t get the same attention, causing issues in areas like supplier management. The issues with NeuFit’s manual system came to light when an FDA auditor arrived with a thumb drive, expecting to be able to load electronic quality documents and take them away with her. Her bag wasn’t large enough to hold the paper documents prepared by the NeuFit team.

VitaCyte began as an early-stage startup funded by an NIH grant as it pursued a commercialization path for reagents used for the recovery of cells used in human transplant therapies. From the outset, the VitaCyte team knew they would need a robust quality management system to achieve their goals. But with limited resources, that wasn’t really practical. So they built a paper-based system from the ground up knowing that they’d have to eventually migrate to something more sophisticated. VitaCyte manufactures ancillary reagents that are used in the preparation of cells, operating in an evolving, yet-to-be-fully defined regulatory space. Recently, the company was audited by a customer’s quality team, and the experience led VitaCyte to begin the process of searching for a new quality management system.

Fix the Mask was created in response to the COVID-19 pandemic. As the virus began shutting everything down, people around the world started scrambling to get masks to protect themselves and their communities. Unfortunately, many of these masks were loose-fitting, which gave virus droplets a path to potentially spread. Seeking a way to give everyone an N95 fit, Sabrina Paseman, CEO of Fix the Mask, and her sister, Katherine, put their brains together and invented the Essential Mask Brace, the nonprofit’s flagship product. As they began trying to bring the product to market, Paseman quickly realized how difficult it was to check every box and get the FDA’s blessing.

30 Technology has two products in development for the market. A quality culture of continuous improvement means the business is constantly looking to challenge existing processes, embed a right-first-time go-to-market approach, and unlock faster, smarter ways of doing things. Above all, a largely remote team required digital access to, and training on, the latest and greatest operating procedures with strict version control. However, a heavily paper-based QMS meant a slew of time-heavy manual processes which cluttered and complicated compliance, as Head of Quality & GxP Compliance Karen Hue discovered when she joined the business. Karen wanted to implement a simpler electronic way of managing the 30 Technology QMS, that matched the company's size. Speed, agility, cost-effectiveness, and ease of use were the primary requirements.

LabPlex acts as the gatekeeper of an expanding product in an undeveloped and still semi-legal market. As the cannabis market expands and certain states compare regulatory standards with a view to an optimal, rigorous benchmark of quality, LabPlex wanted to prove it was meeting the highest standards of the industry and to position itself to grow with the market. But LabPlex was using a basic and manual paper-based operational approach, without a formal eQMS or LIMS in place. The organization wanted to implement a trusted, quality-centric operation, underpinned by a digital quality platform. Quality Manager Ania Washington led the search for a new quality management system.

The company's continued evolution into the life science sector, and their software's use as a medical device data system (MDDS) for preclinical work, prompted the ViQi team to begin planning a quality and regulatory pathway for the future. Co-founder and CTO Dmitry Fedorov wanted to set a solid, proactive quality baseline for the organization in line with their digital, cloud-based 'mindset'. It was important for the business to embrace modern eQMS technology early, before 'progressively more difficult' regulatory demands started to slow company growth. Critically, the organization had no internal quality expertise. Any quality software vendor they found would need to offer a highly supportive and collaborative relationship.

Founder and President Graham Taylor began his career in quality as an associate quality engineer in 2007. Having spent over 15 years in the medical device and pharmaceutical worlds, he recognized the importance of an optimized QMS as he set up Helix. At a previous role, Graham battled the time and effort demands of a paper-based quality system, which included constant circulation, completion, and filing of paper documents. A single FTE, a full 10% of labor costs, was swallowed up by quality admin demands. With Helix as a blank slate, Graham wanted to sidestep the effort of paper and build an efficient, easy-to-run quality system from the company's first days.

eClinical Solutions could get by with a paper-based quality management system while they were still a small, single-site operation. Things began to change as the company expanded its growth (including its Indian operations), widened its hiring radius and embraced more remote work, and as COVID-19 arrived. The company moved to a trial master file-based content management platform but found it lacked the extra QMS functionality they needed, such as full CAPA and training management. It was clear eClinical Solutions needed a holistic, purpose-built eQMS. VP of Quality & Compliance Evan Grunbaum and his team started to search for a tool which would eliminate their manual ceiling and free up the company to scale.

Restech and its Director of Quality Assurance, Lowell Hoffman, faced significant challenges with their manual, paper-based quality management system (QMS). The old system was labor-intensive, time-consuming, and prone to human errors. Document control was particularly problematic, with local saving of document copies preventing access to centralized, up-to-date information. The process of creating paper folders and collecting wet signatures was also time-demanding. These inefficiencies hindered Restech's ability to maintain strong document control, which is crucial for a robust QMS, especially in the medical device industry where regulatory compliance is stringent.

SimBioSys faced the typical challenge faced by any life science start-up: the blank slate. The company in its fledgling state had no internal regulatory expertise or a functioning quality management system. Besides a handful of documents in a OneDrive folder, the company lacked a real quality structure or documented basics like a quality manual. When VP of Regulatory & Quality Hilary Baldwin joined the team, she brought some valuable eQMS experience with her and recognised the powerful business benefits of going straight to a digital eQMS and sidestepping paper altogether. The remote, software-focused and pro-digital culture of the business supported this decision. Hilary's first task was therefore to position the company for success by implementing a suitable, trusted eQMS platform to build the company's digitized quality system into. Along with VP of Software & IT Michael Hallock, she began the search.

First Service Residential Realty was using Yardi Voyager, a software better suited for multifamily managers, which posed significant challenges. The main issue was the difficulty in gaining quick access to data and providing the right information for property owners. The company needed a scalable solution that could handle thousands of properties, be easier to learn and operate, and offer better data accessibility. They turned to LinkedIn Groups to research and compare different software providers, leveraging the opinions and experiences of property managers across the U.S. Using the Net Promoter Score (NPS) system, they analyzed 4,000 entries from LinkedIn to identify the most recommended software. This extensive and time-consuming process revealed that AppFolio had the highest NPS, leading them to consider it as a top contender.

Cassidy & Associates had been using Yardi for over 20 years but found it increasingly inefficient. The company was duplicating efforts on various tasks, leading to wasted time and resources. An intern from UCSB, who later became an employee, encouraged the company to embrace technology to streamline operations. The goal was to save time and eliminate redundant steps, which led to the decision to upgrade their systems and adopt new technology.

When Gil and Sylvia Hill bought H.M.S. in 2002, the company managed approximately 300 properties. Today, H.M.S. oversees nearly 450 properties with the help of 10 employees. Their strategy for effective property management begins and ends with high quality service to owners and tenants. H.M.S.’s growth and ability to provide superior service, however, was strained by the very thing that was supposed to keep the company running smoothly — the company’s property management software. In fact, H.M.S. had acquired another company that used a different software product. This resulted in having to use two different software packages for owner statements, disbursements, and tracking. The Hills also found that they were on the road quite a bit for industry teaching events and seminars as well as spending time with family, especially their grandchildren. They realized that they needed a property management solution like AppFolio that would provide comprehensive management capabilities, enable the company to grow and also allow access to critical data while traveling.

MC3 Multifamily was using Propertyware for property management and Quickbooks for accounting. As their business grew, they needed a more integrated and efficient solution to streamline operations. They sought a complete property management system that could handle everything from tracking prospects to managing residents and handling accounting, all in one platform. The goal was to improve efficiency, reduce costs, and enhance the overall management experience.

Register Real Estate was using Propertyware, but the solution was falling short of their ease-of-use expectations and need for greater efficiency. Basic tasks required too many steps to complete, resulting in inefficiencies and wasted time. Additionally, the costs for adding features to the product were high, and the solution did not provide easy owner access to statements or work orders. Register needed a more cost-effective solution that delivered greater efficiency, simple pricing, and the ability to make direct ACH deposits.