EAM Preserves Order in an Ever-evolving Life Sciences Industry
A comprehensive enterprise asset management (EAM) program directly addresses quality and compliance issues in life sciences to drive reliability.
Life sciences is an expansive industry, covering pharmaceuticals, biotech, biomedical, cosmetics, food processing and other disciplines. Simply put, if a business manufacturers goods or provides services directly concerning the lives of organisms, it stands with others like it under the umbrella of life sciences.
And as organisms evolve over time, so to do these disparate fields of study, albeit at a much faster clip. A 2016 report released by Deloitte predicted a substantial 6.82 percent annual growth for the health care wholesale and distribution market until 2019, spurred not only by expansion in pharmaceuticals but technological advancements achieved in related areas. One could say all the separate sections of life sciences coexist symbiotically in relationships similar to those maintained by different resources within the energy sector. The rise or fall of one usually signals the development or contraction of another.
However, life sciences are not only subject to market fluctuations and innovations, but also to the health and well-being of those who ingest their goods or utilize implants, as well as the regulators tasked with assuring the quality and safety of these products. Whether companies succeed to uphold these parameters depends on their personal commitment to the cause. No organization system, hardware model or software can guarantee complete compliance 100 percent of the time, and that's a good thing. Such a system places the onus squarely on business leaders to adapt to new challenges with in-house innovation and careful consideration to avoid the risks and high costs in eschewing quality for profit.
A comprehensive enterprise asset management program directly addresses issues of quality and compliance in life sciences to drive reliability both in equipment performance and in ancillary operations in this highly competitive and tightly monitored industry.
Understanding asset performance through technological complexity
The engine of innovation is alive and well in the life sciences industry, but can asset management keep up? A 2015 Accenture survey revealed 70 percent of executives from life sciences companies believe next-gen interconnected and interoperable technologies utilized in their field, both customer-facing and internal, will not be outsourced through third-party tech companies, but instead will develop from "industry players and leaders."
No doubt the low price points of digital assets like cloud computing networks and scalable virtualized environments make research and development more lucrative for life sciences, as well as the declining costs of sensors and telemetry equipment heralded by the Industrial Internet of Things. In a recent Thomson Reuters State of Innovation study, life sciences fields saw astounding patent increases. For instance, medical device patent volumes grew 27 percent in the last year alone.
This new era in life sciences innovation calls for a new approach to commissioning, observing, maintaining and repairing these capital-intensive assets, especially when considering both their intricacy and the gravity of what these technologies set out to accomplish. EAM solutions such as IBM Maximo of Infor EAM allow adopters to easily integrate new technology into an intelligent asset management hierarchy and begin monitoring performance immediately. Additionally, as we'll expand upon in a bit, the ability to intelligently leverage operational data – both to inform asset maintenance schedules and the quality of the labor – places the power of continuous compliance within the reach of life sciences businesses, even those at the razor's edge.
Establishing a new standard for compliance in life
Local, state, and federal governments, the International Organization for Standardization, the U.S. Food and Drug Administration, Good Manufacturing Practices – many organizations oversee the goings-on in the life sciences industry and for good reason. Businesses capitalizing on the health and well-being of living things ought to be held accountable for actions believed contrary to this endeavor.
In life sciences and elsewhere, EAM strategies like proactive maintenance prove effective in preserving the quality of products by ensuring the machinery behind production operates as intended. However, as is typical of technology-driven sectors, product quality is but a single corner of the larger compliance picture. Compliance also means:
- Protecting operational data.
- Effectively delivering data to decision-makers.
- Reporting necessary findings to regulators.
- Cataloging information for posterity.
The FDA's "Part 11" requirements for electronic recordkeeping and signatures are excellent examples. These regulations don't merely strive to ensure the quality of ingested goods, but they also modernize the checks and balances companies obey to simplify, strengthen and increase engagement with these processes.
"True compliance isn't bought at a store."
True compliance isn't bought at a store and installed on site – it is a methodology an organization adheres to, one in support of transparency, innovation and accountability. And unfortunately, life sciences struggles to keep up. A Deloitte survey found less than half of compliance officers and professionals believe in the sufficiency of their compliance reporting systems. Even fewer believe their organizations' current compliance monitoring and reporting processes function well enough to "enable positive intervention." What value could these compliance architectures possibly possess if they don't allow life sciences companies the proper tools to catch and subvert violations before they happen?
The best EAM solution providers understand these pain points and, in turn, develop tools designed to combat them. They focus on delivering software capable of gleaning real-time data and visualizing it all in easy-to-read dashboards available for terminals and mobile devices, as well as facilitating the integration of third-party software or devices needed to calibrate and validate asset performance. With a proactive maintenance program to back it all up, companies become more responsive to the equipment deficiencies which jeopardize compliance.