Starting and successfully running a small business is challenging enough. Now consider the prospect of losing it all simply because something fell through the cracks, and you ran afoul of stringent industry regulations. That's a bitter pill to swallow.
Small businesses that operate in regulated industries—manufacturers of consumer goods, biotech, or medical technology firms to name but a few—must take regulatory compliance and quality assurance seriously, according to Matt Lowe, executive vice president of business software specialist MasterControl.
An investment in enterprise quality management software (QMS) can help, and here's the good news; Lowe says that it's not out of reach for smaller firms.
What is Quality Management Software (QMS)?
As the term suggests, QMS software lets big manufacturers, pharmaceutical firms, and medtech device makers maintain proper safety and quality standards, such as those imposed by U.S. Food and Drug Administration (FDA) and other regulatory and standards bodies. A blend of technology and automated business process management, optimization, and collaboration, QMS helps businesses avoid regulatory mishaps by keeping all stakeholders on the same page during the product development phase and beyond.
A QMS system lets you securely track and account for all documents, thus eliminating out-of-date or conflicting specifications. Should issues or flaws arise, you can use QMS to kick-start and document the remediation process, putting the product development process back on track.
On the surface it sounds like a lot of work—and it is.
Enterprises pour a hefty portion of their IT budgets into maintaining regulatory compliance, not to mention the salaries paid to IT, operations, and quality assurance (QA) managers. To level the playing field for small businesses, MasterControl engineered a cloud-based QMS solution.
Quality Management Software (QMS) in Matters of Life and Death
It's a good time to be an entrepreneur, especially in life science and healthcare fields. The advent of cloud computing, 3D printing, and countless mobile computing innovations has demolish the barriers to bringing the latest life-saving medical device or diagnostic test to the market.
However, regulatory compliance major remains a stumbling block. Even if inventors and entrepreneurs are well-versed on the rules governing their industries and know what they're getting into, their business processes may not. Even the smallest business can run into big trouble if its quality standards slip.
Releasing a product that endangers its users—placing them at risk of either harm or death—is simply bad business and even worse karma.
While considered a business software provider, MasterControl is in the "risk reduction market," Lowe told Small Business Computing. "Being out of compliance with some of these regulations can mean going out of business."
Founded in 1993 and based in Salt Lake City, Utah, MasterControl has helped nearly 1,000 organizations stay on the right side of their regulatory obligations. "Typically buyers are in the quality assurance department," said Lowe. "They're primarily concerned with making sure that their companies meet their compliance [standards]. Everybody participates in that process, but QA carries the torch."
Naturally, small businesses have fewer hands available to carry that torch. To compensate, Lowe's company launched MasterControl Spark, a cloud-based QMS system that provides the aforementioned capabilities, but in a preconfigured, IT-light package that fits into small business budgets.
Prices start at $109 per person, per month for the Basic plan. It offers document management and PDF publishing. Stepping up to the Advanced Plan ($169 per person, per month) adds corrective and preventive action (CAPA) features. Finally, the All Access plan ($199 per person, per month) includes training and auditing, along with risk and bill of materials (BOM) management.
Software aside, MasterControl offers consultancy services that can help entrepreneurs launch their companies with QA built-in. "We have experts on staff that can take a biotech startup and get its business processes solidly in place," said Lowe.
Pedro Hernandez is a contributing editor at Small Business Computing. Follow him on Twitter @ecoINSITE.
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