Sophisticated software systems provide an essential compliance tool for a regulated industry operating in a global economy.
Regulatory processes and quality systems are not new. Principles such as lean manufacturing, QIM, MES, Six Sigma and others originated in the defense, aerospace, and automotive industries, as did the vast majority of companies that are currently supplying medical device quality and compliance software. Most have roots in these highly regulated industries, but they have turned their attention to the unique needs of med-tech manufacturers.
Automating compliance processes
It is not mandatory to automate regulatory and reporting procedures. But given the global reach of most companies today, and the fact that it takes a lot of data-entry hours and paperwork to remain compliant, it makes sense to automate compliance procedures.
Several types of software are on the market. Some are narrowly targeted to satisfy regulatory requirements. Others offer more complete quality analysis capabilities. Comprehensive programs cover the entire enterprise and a product’s cradle-to-grave (and beyond) life cycle. Typically, they include sophisticated analysis software that allows top management to exercise complete control regardless of a company’s size, global footprint, or breadth of market.
The single thing that ties all software solution companies together is the Internet. To provide the instant reporting speed, data collection and analysis worldwide, all must offer web-based solutions.
Pilgrim Software (Tampa, FL, USA) provides enterprise compliance and quality management software for US FDA–regulated life science industries. Pilgrim’s web-based solutions help businesses to centrally manage domestic and international operations to ensure product safety and compliance, reduce manufacturing costs and improve customer satisfaction. Its software covers all the regulatory requirements as well as areas of quality assurance within company processes.
"One of the leading items we provide for medical device manufacturers is our Corrective Action & Preventative Action (CAPA) product, which is a complete solution from tracking incidents of noncompliance to investigation and cost analysis," says Nikki Willett, vice president, marketing and regulatory products. "It also provides implementation of the corrective fix and preventive action and, of course, the quality review afterwards to make sure that they were successful," she adds.
"The added benefit of getting the right kind of data in a fast, accurate way allows a company not only to meet mandatory issues, but to become proactive," says Willett. "The data can be leveraged into understanding the root causes of any event, so the company can implement a risk management and risk minimization programme."
Software aims for flexibility and exhaustivity
Camstar Systems Inc. (Charlotte, NC, USA) offers an MES (manufacturing execution system) and quality system combination. The firm’s Medical Device Suite is geared to manufacturing compliance and quality. "Our software helps in both aspects," says Rajkumar Raqupathi, life sciences solutions consultant. "But we go beyond and also cover enforcement of good manufacturing processes (GMP). We have the complete solution for modeling, manufacturing, and quality directives," he says.
"It is an enterprise-like system," says Susan Lamb, senior manager of product marketing. "We have [designed] it so that multiple sites can log into it for a single solution, and we have installed some on a single plant level. It is very flexible," she adds.
Like Pilgrim, Camstar’s software is completely web based, and all access to the system is through a special client browser. It is one of the things that makes its programs so easy to access for customers worldwide, according to Lamb.
The program puts a precisely detailed manufacturing record at users’ fingertips, allowing them to take preventive action in all areas of manufacturing from throughput and cycle times to trend analysis.
The platform uses screen "dashboards" that are specific to different roles in an organisation. If the user wants to do a status check on compliance in one area of the facility, a dashboard will indicate how many complaints were received, the status of audits and internal defects, and so forth.
Sparta Systems Inc. (Holmdel, NJ, USA) offers Track Wise software that electronically records, tracks, manages, and reports on various types of quality-related issues and actions including noncompliant manufacturing, CAPA, and customer complaints.
"At the upper level, the manufacturer needs to keep tabs on these issues and to monitor for trends and systematic problems," says Steve Cagle, vice president of marketing. "Our solution has user friendly yet sophisticated reporting engines. The manufacturer can get reports not only on who is assigned to what and what needs to be done, but he or she can also produce trending analyses across different areas to monitor for systematic quality problems. This is a web-based system that can tie into all areas for a total quality solution," he adds. "It features a point-and-click tool set, with high scalability—you can literally scale to thousands of users. It also has multilanguage capabilities."
"It’s very easy to make changes in our programs, and it eases the burden of software validation," Cagle adds. "The user isn’t changing codes: he or she is only using the out-of-the-box system and [introducing changes] through the system parameters that are provided."