Formpipe Life Science: Platina- The Next Generation QMS

Keith Williams, Managing Director Life Science
The technology used in compliance environments is becoming increasingly complex. “This is a major obstacle for life science organizations in achieving their quality and compliance goals,” comments Keith Williams, Managing DirectorLife Science, Formpipe. “We simplify complex processes and technology environments, enabling organizations to be confident that they have the right information at the right time to withstand any audit.” Furthermore, the challenges that come with today’s widespread outsourcing, the geographic spread and mobility of the workforce, along with the increasing burden of regulatory compliance, are all adding to the woes of life science companies.

Led by life science experts with over 25 years of experience, Formpipe delivers compliant software products of the highest standards that address the growing quality management needs. The company’s key offerings include an enterprise-level Electronic Quality Management System (EQMS) called Platina Life Science ™ and X-docs™, a Foundation and Cloud EQMS. “X-docs™ is based on SharePoint and draws inspiration from Microsoft Office’s ribbon interface which customers are familiar with,” reveals Williams. It is a tool best suited to companies employing paper based systems or hybrid environments. While X-docs™ is meant for 50 to 2000 users, Platina™ is significantly more scalable—up to 25000 users— but an enterprise system that can be configured in 50 days and not 12 months. Some of the other products of Formpipe are Long - TermArchive — a solution that lets organizations store and retrieve their records decades down the line and set the retention and deletion rules based on the type of document; LaserNet, which allows users to access the ERP templates directly and make changes to them without the need for expensive programming; and Email Resolver, which ensures that all the incoming emails are stored correctly in the X-docs™ EQMS as records with the associated metadata.

“We believe in breaking the silos and managing content and quality activities across the organization in a horizontal manner,” states Williams. This allows analysis of Quality information and Quality and Compliance activities to be value add to the business, not just cost centers.
Moreover, as users desire more configurability in software, Formpipe’s products offer additional configurations as the customer’s needs change, or new regulations require further compliance activity. “Besides us, no one in this space provides the focus on the user that we do. We work with ergonomists to achieve that level of usability in our software,” remarks Williams.

A successful implementation of EQMS involves people, technology, and process interacting efficiently. However, many projects fail as the focus is on technology alone. “Introduction of an EQMS should improve the bottom line of a company and is no different from any Change Management process. There has to be buy in at the highest level to ensure that one group does not specify a system to their requirements at the expense of the wider business.” Formpipe’s tools allow efficient configuration and reporting of Quality metrics, while being easy to manage, maintain, and use. “You don’t need a PhD in EQMS to use Formpipe’s products,” emphasizes Williams.

You don’t need a PhD in EQMS to use Formpipe’s products

X-docs™ was the solution that Laboratory of the Government Chemist (LGC), an international science-based laboratory services company, turned to when it needed to manage its quality documents like policies, guides, and document templates. “We piloted X-docs™ out initially to 100 users which is now rolled out to 400 users in Europe and the U.S.,” says Williams.

In addition, the Quality Processes module X-forms™ helped LGC manage the findings and outcomes of their various internal, external, and regulatory audits. The strength of X-docs™ is evident in how LGC today effortlessly manages over 20,000 audit items in Formpipe’s system—something that would be virtually impossible to manage in Microsoft Excel.

Formpipe Life Science

Red Bank, NJ

Keith Williams, Managing Director Life Science

The Life Science division of Formpipe offers a suite of different products to address the compliance and quality needs of the life science sector, all designed to be easy to use, increase efficiency and reduce costs across organisations from 50-25,000 users.