Pharmaceutical manufacturers use PLM to swallow bitter regulatory pill

Pharmaceutical manufacturers are focusing attention and resources on product life-cycle management (PLM) adoption, according to a report out of London-based Datamonitor, titled Streamlining Information in the Pharmaceutical Industry with PLM. “Similar to other industries without a traditional focus on PLM, there have been above-average growth rates in PLM for pharmaceuticals and biotechno...


Pharmaceutical manufacturers are focusing attention and resources on product life-cycle management (PLM) adoption, according to a report out of London-based Datamonitor , titled Streamlining Information in the Pharmaceutical Industry with PLM .

“Similar to other industries without a traditional focus on PLM, there have been above-average growth rates in PLM for pharmaceuticals and biotechnology,” states Roy Wildeman, a senior analyst with Forrester Research GmbH , Frankfurt, Germany.

In addition to regulatory compliance pressures and increased competition, Datamonitor says interest in PLM is driven by the need to accelerate drug development processes.

PLM addresses the challenges of managing a portfolio of tens or hundreds of drug candidates from a number of R&D facilities and manufacturing plants around the globe. PLM also supports regulatory compliance by including applications that track adherence to regulation codes and identify noncompliance risk.

“Pharmaceuticals manufacturers face a dual challenge of increased product compliance and regulatory scrutiny, along with downward pressure on revenues from patent expirations on blockbuster products,” adds Wildeman. “Other reasons are insufficient R&D pipelines and government pricing controls.”

Focusing on PLM product and process knowledge is one lever pharmaceutical companies can use to offset these pressures, Wildeman adds.

“Many PLM vendors are seeking ways to grow market share in new verticals, including specializing their offerings to serve the unique product and process requirements that pharma and other nontraditional sectors have,” says Wildeman.

So it seems the potential benefits of PLM to pharmaceuticals manufacturers are growing in scope.

“In terms of quality and compliance, PLM software can capture, monitor, and manage the impact that material selection and process parameters can have on product quality,” states Wildeman, which allows users to consistently achieve target quality profiles and comply with regulatory requirements.

In terms of efficiency, centralizing product and process data in a core PLM repository promotes more accurate design information so that nonvalue tasks such as copying data between data sources or searching for missing information are reduced or eliminated.

“At the end of the design process, assembling scattered product data for tech transfer and commercial ramp-up also can be a chaotic and time-consuming endeavor,” Wildeman explains. “A centralized PLM system can ease this transition of data to manufacturing.”

One key to success in PLM adoption is a strategic mind-set, according to Markella Kordoyanni, pharmaceutical technology analyst for Datamonitor, and author of the report.

“Although the industry is starting to recognize the potential benefits of PLM in drug development, unless pharmaceutical companies adopt a strategic mind-set about PLM—with all of the process management changes and cultural adaptations it requires—PLM will remain a tactical solution whose potential is not maximized,” says Kordoyanni.

The report suggests an enterprisewide PLM system is required to maximize the value of PLM. It's also important to partner with a PLM vendor because while PLM at its core aligns closely with pharmaceutical industry business processes, most PLM solutions lack configurability attributes and other essential features. Working with a vendor will combat those challenges.

Leading PLM vendors with presence in pharma:

Infor (


Siemens UGS PLM (

Oracle Agile PLM (


No comments
The Top Plant program honors outstanding manufacturing facilities in North America. View the 2013 Top Plant.
The Product of the Year program recognizes products newly released in the manufacturing industries.
The Engineering Leaders Under 40 program identifies and gives recognition to young engineers who...
A cool solution: Collaboration, chemistry leads to foundry coat product development; See the 2015 Product of the Year Finalists
Raising the standard: What's new with NFPA 70E; A global view of manufacturing; Maintenance data; Fit bearings properly
Sister act: Building on their father's legacy, a new generation moves Bales Metal Surface Solutions forward; Meet the 2015 Engineering Leaders Under 40
Cyber security cost-efficient for industrial control systems; Extracting full value from operational data; Managing cyber security risks
Drilling for Big Data: Managing the flow of information; Big data drilldown series: Challenge and opportunity; OT to IT: Creating a circle of improvement; Industry loses best workers, again
Pipeline vulnerabilities? Securing hydrocarbon transit; Predictive analytics hit the mainstream; Dirty pipelines decrease flow, production—pig your line; Ensuring pipeline physical and cyber security
Upgrading secondary control systems; Keeping enclosures conditioned; Diagnostics increase equipment uptime; Mechatronics simplifies machine design
Designing positive-energy buildings; Ensuring power quality; Complying with NFPA 110; Minimizing arc flash hazards
Building high availability into industrial computers; Of key metrics and myth busting; The truth about five common VFD myths

Annual Salary Survey

After almost a decade of uncertainty, the confidence of plant floor managers is soaring. Even with a number of challenges and while implementing new technologies, there is a renewed sense of optimism among plant managers about their business and their future.

The respondents to the 2014 Plant Engineering Salary Survey come from throughout the U.S. and serve a variety of industries, but they are uniform in their optimism about manufacturing. This year’s survey found 79% consider manufacturing a secure career. That’s up from 75% in 2013 and significantly higher than the 63% figure when Plant Engineering first started asking that question a decade ago.

Read more: 2014 Salary Survey: Confidence rises amid the challenges

Maintenance and reliability tips and best practices from the maintenance and reliability coaches at Allied Reliability Group.
The One Voice for Manufacturing blog reports on federal public policy issues impacting the manufacturing sector. One Voice is a joint effort by the National Tooling and Machining...
The Society for Maintenance and Reliability Professionals an organization devoted...
Join this ongoing discussion of machine guarding topics, including solutions assessments, regulatory compliance, gap analysis...
IMS Research, recently acquired by IHS Inc., is a leading independent supplier of market research and consultancy to the global electronics industry.
Maintenance is not optional in manufacturing. It’s a profit center, driving productivity and uptime while reducing overall repair costs.
The Lachance on CMMS blog is about current maintenance topics. Blogger Paul Lachance is president and chief technology officer for Smartware Group.