As the pharmaceutical industry wrestles with evolving regulations, technical challenges, and mounting pressures to reduce prescription drug prices, manufacturers continue to search for new ways to streamline operations and reduce costs, while increasing quality, safety, and speed to market.
To that end, one major provider of software services to the life sciences sector has introduced a new analytics engine and three new cloud-based applications designed to help pharmaceutical management increase efficiencies, enhance quality controls, and improve business processes.
Salt Lake City-based MasterControl Inc. recently released version 11.7 of its quality management system, an upgraded package featuring enhanced analytics capabilities and three new cloud-based offerings: eTMF Manager; Registrations; and Registrations for eCTD.
The eTMF—or electronic trial master file—software system automates, centralizes, and standardizes the TMF process thus minimizing the burden, risk, and complexity of managing vast amounts of clinical trial data. Without eTMF, managing thousands of documents and massive amounts of data using paper-based or hybrid systems can lead to errors and oversights that potentially place clinical trials at risk of noncompliance.
Registrations software manages product registration and 510(k) device submissions, automates manual or hybrid processes, and tracks the various requirements for every geographic location, creating transparency for effective monitoring of submission bottlenecks.
Registrations eCTD—or Electronic Common Technical Document standard—publishing software allows users to quickly identify content based on region and prepare for electronic submission publishing via a partner in in-house publishing tool. eCTD has been adopted by many countries in order to standardize registration information, eliminating differing regional and other requirements across the various geographical locations.
When it comes to product registration, many life sciences companies are not selling just into the U.S., but selling into a hundred or more geographical locations around the globe, Matt Lowe, executive VP of MasterControl, told Pharmaceutical Processing in a recent interview.
No doubt, tracking the regulatory requirements for a 1,000 different products heading into 100 different countries becomes a daunting task and regulatory affairs folks have been managing the process largely on Excel spreadsheets for years.
“For that many products in that many markets the spreadsheet is up to date for about the five minutes after you saved it because something will change five minutes after that,” Lowe said.
So, new functionality can couple the regulatory dossiers for submission with the product registration management tool, allowing regulatory affairs personnel to track all the different products in all the different countries, he said.
Tying Together Different Technologies
Beyond product registration and regulatory challenges, global companies maintaining physical operations in numerous locations also face internal hurdles in compiling, gathering, and integrating data from many different sources.
Large global companies may have a number of different technologies in place all performing the same task.
“You’ve got to figure out how to navigate that application landscape,” Lowe said, adding that an integrated platform approach is recommended. “In cases where a solution is already in place, (we) will integrate with those tools to make sure the data is in sync and there is only one source of truth across the organization.”
That process usually involves integration with an existing ERP system and, to a lesser extent, integration with the CRM.
In addition, with the improved access afforded by new cloud-based technology, suppliers, distributors, health care professionals, and other third-party partners can be granted a limited level of access into the manufacturer’s system—access only to those particular areas that directly affect them.
At present, more than 90 percent of new MasterControl customers opt for the Cloud upon signing up for services, Lowe said, while the existing customer base is rapidly moving in that direction, with more than half already there.
The Power of Analytics
The analytics engine introduced in the company’s upgraded 11.7 version is powered by Jinfonet’s JReport, a customizable technology that helps to better calculate and track ROI and efficiency gains.
Jinfonet describes JReport as “an embedded reporting and visualization solution that provides highly customizable embedded analytics for web applications.”
Such analytics offerings allow users to view, filter, and interact more with their data. For example, with the latest technology, users can add or subtract columns, images, groupings, summary fields, calculated fields, filters, labels, and graphics.
It is key that the analytics can perform across all business processes and functionality, according Lowe. In some instances, it can help manufacturers identify failures in the field so they can be remedied before they trigger costly breakdowns and potential plant shutdowns.
“For example, (enabling them) to pick up on those failures in a timely manner via the analytics platform, which is reporting and tracking and trending those failures,” Lowe explained. “Being able to also see perhaps that those failures might be related to a specific variance or a non-conformance that occurred in the manufacturing process.”
Identifying Trouble Spots
In many cases, companies oversee each of their business processes using different, stand-alone technology systems or still issue reports via spreadsheets. “It’s really hard to see across the entire value stream and identify the trouble spots,” Lowe said, adding that the new analytics capabilities allow users to look across the entire value stream and see connection points between different areas of the business that they might not otherwise pick up on.
Another benefit with today’s technology, according to Lowe, is enhanced access to predictive analytics capabilities, which can alert users to potential problems developing in the system so they can investigate further. “It may be nothing at all, but it might be something big and you’re able to catch it way before you would otherwise,” he said. “You can save a lot of money, save a lot of heartache in the marketplace, and potentially a recall down the road.”
MasterControl’s main target customers include core pharmaceutical, biotech, and medtech manufacturers, as well as suppliers, distributors, and health care facilities. Historically, the company primarily served medium and large tier clients, but three and a half years ago created Spark, a technology specifically aimed at very small manufacturers—some with as few as five employees.
Using the Cloud
Version 11.7, which involved some extra effort to incorporate the new elements, replaced the previous version that was introduced in November 2016. Going forward, and with the cloud, the company now aims to issue new versions on a quarterly basis.
“We’re not far off from releasing the next version—within weeks,” Lowe said at the time of the interview, adding that users will automatically receive upgrades.
This story can also be found in the March 2018 issue of Pharmaceutical Processing.