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Enterprise Asset Management Technology:
Five Ways To Boosts Profits And Regulatory Compliance
By Eric M. Luyer
Industry Marketing, Life Sciences & Healthcare Markets
MRO Software Inc.
Pharmaceutical manufacturers often fear deploying new automation technologies due to the fatigue of adding more regulations to their already-hefty regulatory burden. New systems impose new validation requirements, they argue. It has put a tough squeeze on senior management as they wrestle with two often-conflicting challenges:
• How can we better use technology to maximize manufacturing performance and profits for our patented products?
• How can we mitigate some of the legal and compliance issues and risks associated with large-scale production?
One answer may be Enterprise Asset Management (EAM) software. Instead of raising the regulatory burden, EAM systems can actually streamline compliance and reduce risks, all while improving manufacturing performance and profits. That’s because EAM focuses not only on an asset’s performance, but also on making smart use of the data derived from the asset (which feeds compliance reporting), as well as the people certified to manage the assets. Here are five ways in which EAM can improve cost savings, productivity and compliance in pharmaceutical manufacturing companies.
1. Unifying a feudal system of disparate asset management tools
EAM takes a holistic approach, uniting all critical assets within an organization. These include not only conventional plant and machinery assets, but also those assets responsible for transporting people, raw materials and finished product; facilities, grounds and infrastructure; and the tools of the knowledge worker – the PCs, PDAs, networks, servers and other communications infrastructure.
Due to the industry’s slow adoption of new technologies, systems for managing
these assets have often been acquired piecemeal. They typically employ standalone
or homegrown applications or laborious paper-based processes for each class of
assets…and then a different application for maintenance planning and scheduling…and
yet another one for workflow…and calibration…and IT systems, etc. It has triggered
a feudal system of non-integrated systems which lead to lack of control and visibility,
high cost of ownership, lots of errors, and ineffective decision support.
EAM provides a central way to manage all critical assets within an organization as a single ecosystem. Rather than having to jump between dozens of portals into the enterprise, EAM provides global visibility for managing assets strategically. It provides significant costs savings in software licensing, support and training costs.
System unification also benefits our next issue – compliance – because lack of
it can dramatically increase the cost of compliance. If the cost for obtaining
compliance requires access to many fragmented systems, compliance costs and labor
requirements skyrockets.
For example, EAM provide a rational suite of asset management-related applications and offers full capability to manage requirements for: CAPA (Corrective Active/Preventive Action), Calibration (and Mobile Calibration), managing all critical assets, preventive and predictive maintenance, work order scheduling, inventory, procurement, service management capabilities including service level agreements, etc. These capabilities can be uses in one system, using the same data elements and no need anymore to have a variety of different in place to support these different requirements.
2. Minimizing compliance issues
Pharmaceutical manufacturing has traditionally been treated as a “Cinderella” function in the R&D-centric industry and has been managed internally with a “cause no problems” mentality. This is not likely to change, but the fact remains that the FDA and other regulatory bodies scrutinize manufacturing processes as much as they do the R&D of a drug. Any changes to assets involved in the manufacturing process needs to be carefully monitored, tracked, validated and approved. While the FDA has not relaxed its regulatory requirements, it has given manufactures greater freedom to employ information technology to meet those requirements.
Consequently, many manufacturers are employing compliance strategies that use
paperless validation. FDA regulation 21CFR, Part 11, requires the use of digital
signatures (a.k.a. e-signatures) and methods that ensure the integrity of electronic
records. Traditional paper-based processes of capturing the compliance data are
not only expensive and time consuming, but extremely error prone. Using an electronic
verification system streamlines the audit process, ensuring both good will with
the FDA and increased plant uptime with regards to mandatory manufacturing practices
and maintenance routines. On the flip side, failure to meet 21CFR can result in
plant shutdown, revenue losses and painful fines from compliance agencies.
EAM systems are today intrinsically designed to facilitate 21CFR compliance. For example, EAM can automate the collection and validation of compliance-related data to determine the total cost of compliance. All work orders, work history and safety plans can be easily tracked and maintained in a paperless system. And if the EAM system has mobile communication capabilities, this data can be captured in real time at the point-of-performance, reducing the time spent on paper work and data entry further. Otherwise, failure to automate these processes and managing the assets that contribute significantly to the cost of compliance can consume as much as 25 percent of a plant’s total budget.
3. Extending good manufacturing practices (GMP) and best practices to maintenance
A preventive-focused maintenance approach to asset management combined with a condition-monitoring system for equipment helps to ensure manufacturing consistency and quality. EAM can help the cause by standardizing good manufacturing practices (GMP) and best practices across the organization. For instance, EAM systems can track metrics such as critical levels, readings and event-based conditioning monitoring along with their related regulatory documentation. These metrics can be multi-level: more data output to get more insight either volume, production output, sizes, levels, distances, etc.
EAM systems can automate the scheduling of preventive maintenance activities during
planned downtimes to maximize the usefulness of an asset, while maintaining its
historical information and performance indicators. They can also manage and automate
Corrective Action-Preventive Action (CAPA) processes. CAPA processes, which are
required quality measures in the 21 CFR 820.100 and 21 CFR 211.180 regulations,
ensure that possible failures are monitored and reported, the root cause of any
problem is identified and fixed in order to avoid future problems.
The end result of automating GMP and best practices across the plant is greater reliability of assets, lower process and product variability, less equipment downtime, and a structured and visible managed system. For instance, EAM systems provide management information for all levels in the organization using graphical reporting with Key Performance Indicators (KPI’s). This type of information is mostly displayed in a so-called Management Dashboard.
4. Ensuring accurate, standardized calibration capabilities
Calibration is a critical function for many organizations, particularly those that operate in regulated industries and where tools and instruments are an integral part of the maintenance activity to check, adjust or systematically standardize graduations of quantitative output measurements. The proper calibration of an instrument is a mission-critical activity, as instrument errors can diminish safety, compromise product quality, damage plant assets, increase operation costs and reduce profits.
Calibrated assets include tools, equipment and standards, whereby instruments
are calibrated with the known standards and the standards are calibrated with
even more accurate standards. The objective of Calibration is to ensure that an
asset’s output properly corresponds to its applied input or to remain at it’s
peak performance.
Pharmaceutical manufacturers must validate the accuracy of its instrumentation to meet compliance requirements. Yet even today calibration settings and accuracy for different instrumentation and equipment and can vary even within a single plant. An EAM system can enforce calibration standards, converging specifications for every asset into a single database. Accurate, standardized calibration is critical because inaccuracies can lead to severe regulatory penalties, wasted manufacturing resources, and even cost lives. Benefits realized using Calibration functionality include improved safety and (again) adherence to compliance regulations, along with reduced downtime and operating costs.
5. Validating human expertise
EAM systems focus not only on the physical assets, but also on the people responsible for operating and maintaining them. Regulatory requirements in the life sciences industry insist that only skilled and certified professionals operate or perform tasks on some specific equipment.
EAM systems can track and align the qualifications and certifications of the workforce
to specific activities related to specific assets, while providing e-signature
and electronic audit trails to meet compliance reporting requirements. They can
also control access to those assets, authorizing only qualified experts to perform
specific activities.
Conclusion
For senior management wrestling with the need to improve manufacturing efficiencies
while coping with a growing regulatory burden, EAM systems offers them a solution.
EAM lets them view and manage asset performance across the plant. By managing
critical assets more closely, they can increase shareholder value by improving
the uptime of critical revenue-generating assets, by reducing the costs of acquiring,
managing and maintaining those assets, by managing legal compliance, by reducing
risk, and by creating a competitive advantage.
Pharmaceutical Processing
Advantage Business Media
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