A Competitive Approach to Regulatory Compliance in Life ... - Apriso

A Competitive Approach to 

Regulatory Compliance in 

Life Sciences Manufacturing 

JULY 2006

Table of Contents 

The Challenge of Regulatory Compliance ..................................................... 3 

Why a Traditional MES Hasn’t Been Enough ................................................ 3 

What is Needed: A Next Gen MES ............................................................... 4 

Apriso’s Global Approach to Manufacturing Excellence ................................ 5 

A Comprehensive Solution for Life Sciences Manufacturers ......................... 6 

The Power to Act ........................................................................................... 8 

The Return on Investment ............................................................................. 8 

Get There One Plant at a Time ...................................................................... 8 

Conclusion ..................................................................................................... 9 

About Apriso ................................................................................................ 10 

© 2006, 2010 Apriso Corporation 

This white paper, the software described in it, and other program materials are copyrighted works of Apriso Corporation, with all rights reserved. 

Trademark Information 

Apriso and FlexNet are registered trademarks of Apriso Corporation. 

Limitation of Liability 

The information in this document represents to the best of our ability the product functionality of Manufacturing Execution, Manufacturing 

Operations Management and other software products. These materials are subject to change without notice. These materials are provided by 

Apriso Corporation for informational purposes only, without representation or warranty of any kind. Apriso Corporation shall not be liable for 

errors or omissions with respect to the materials. The only warranties for Apriso Corporation products and services are those that are set forth in 

the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an 

additional warranty. Version 1006.0. 

2 A Competitive Approach to Regulatory Compliance in Life Sciences Manufacturing

The Challenge of 

Regulatory Compliance 

Achieving best practices has become a major goal of manufacturers in all industries. In the life 

sciences field, it is more than a goal; it is a requirement, and a highly complex one at that. 

The life sciences industry is heavily regulated, with requirements at all stages of manufacture, 

from risk-reducing design and formulation processes, to quality production controls, to 

management oversight. The typical manufacturer today must deal with a range of regulations 

within the United States—from the federal level down to state laws and regulations—as well as 

a growing body of international standards from the European Union and other regions. 

These regulations are far more than formalities. The U.S. Food and Drug Administration, for 

example, will regularly "monitor product problem data and inspects the operations and records 

of life sciences developers and manufacturers to determine compliance." 1 

The cost of noncompliance 

can be high, both in dollars and in public reputation, as recipients of recent FDA 

warnings can attest. 

For all of these reasons, quality management has become a critical boardroom issue for life 

sciences manufacturers worldwide. 

But being aware of the problem, and being able to manage it, is two different things. In a very 

practical sense, quality management starts on the production floor through control processes 

commonly known as MES, or Manufacturing Execution Systems. And in most companies, 

these processes are far removed from the view of the corner office. 

Why a Traditional MES 

Hasn’t Been Enough 

A Manufacturing Execution System (MES) is a set of software tools that provide for a largely 

paperless, automated production process with the control and audit trails needed to 

demonstrate compliance. 

For example, MES ensures that the latest Bills-of-Material or Formulations and routings are 

enforced, operators are certified to do specific tasks, latest work instructions are available, 

equipment is calibrated, and final acceptance processes are enforced. Such a system creates 

a partial paperless DHR or BR as required by the 21 CFR Part 820, 210 and 211 regulations, 

and provides compliance with the 21 CFR Part 11 requirements for electronic signatures and 

1 

Medical Device Quality Systems Manual, U.S. Food & Drug Administration; 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySy 

stemsRegulations/MedicalDeviceQualitySystemsManual/default.htm 


electronic records. MES also provides some degree of quality management through collection 

of lab and test results, and the tracking of non-conformances and rework. Some systems also 

provide CAPA workflows for driving corrective actions. 

Yet increasingly, life sciences manufacturers are finding that traditional MES solutions are not 

helping them reach their goals of both compliance and competitive, agile manufacturing. The 

reasons are many, and include: 

� Disparate systems across plants. The Aberdeen Group reports that "many 

companies have a hodgepodge of systems and technologies in their plants which are 

costly to maintain and difficult to modify." 2 

Many MES systems date from a different 

technology era, and companies frequently have multiple homegrown systems or 

customized packages. Thus, each individual plant may be well controlled and 

compliant, but collectively the manufacturing operations are difficult if not impossible 

to manage optimally. 

� Lack of agility. Rolling out best practices for a new product or new plant is difficult in 

any industry, but especially so in the life sciences field, where regulatory concerns 

multiply the challenges considerably. As a result, executives are constantly faced 

with the conflicting choice of accelerating product introduction for competitive 

reasons, or slowing it down in order to ensure compliant, quality best practices. This 

problem is made far more severe by the disparity in, and rigidity of, current MES 

approaches. 

� Poor visibility. Despite flashy new software such as executive dashboards, most 

executives are still managing largely in the dark when it comes to seeing and 

understanding actual operations. The problem is that dashboards can be deceptive 

or even misleading, because the KPIs (Key Performance Indicators) they present are 

based on data collected and measured in different ways, from plants in different 

locations. Says one consultant for ERP in Lean and Six Sigma manufacturing: "I've 

been going into multibillion dollar companies since 1994 and … only about 70 percent 

of the inventory balances I see are accurate." 3 

� Lack of ability to direct manufacturing decisions. Perhaps most problematic of 

all, as long as the plant floor is a hodge-podge of technologies and systems, there is 

no effective way to drive decisions to the operations level. For example, an executive 

can decide it would be more profitable to shift manufacturing resources to support a 

growing life sciences product line, but there is no clear way to make that happen on 

the manufacturing level. 

Despite these challenges, executives are ultimately responsible for compliant operations in 

their plants, despite whether or not their systems can provide the necessary visibility and 

control to address the FDA’s requirements. 

What is Needed: A Next Gen MES 

Both analysts and manufacturers say that what is needed is a new generation of MES that is 

designed to address the local needs of each plant, yet allows the standardization of plant data 

that feeds accurately and automatically from across the enterprise, up the chain to the ERP 

system. 

2 

“Global Operational Excellence Benchmark Report: MES and Beyond," Aberdeen Group, May 2006 

3 

“Lies your ERP system tells you," by Alan S. Brown, Mechanical Engineering, March 2006 


At the same time, life sciences manufacturers need to drive quality down to the plant floor. 

Further, notes ARC Advisory Group, companies want "easier, more automatic changeovers 

when new products are introduced." ARC says that manufacturers are looking to Service 

Oriented Architectures (SOAs) and "integrated suites of applications that knit together all of 

their execution, logistics, maintenance, quality, tracking, reporting, and visibility needs 

throughout all operations and across multiple plants." 4 

In order to accomplish each of these goals, Life Sciences manufacturers need: 

� Global management of processes and sites in order to manage compliance and 

implement best practices 

� Uniform standards across the enterprise for tracking, measuring and viewing 

performance 

� Ability to record, report and view production data across the enterprise. 

In the next section, we look at how Apriso addresses the need for a Global Manufacturing 

System, and how the Apriso solution can be used by life sciences manufacturers to ensure 

compliance and achieve best practices throughout their operations. 

Apriso’s Global Approach 

to Manufacturing Excellence 

Apriso Corporation has developed an integrated Global Manufacturing Suite that allows 

manufacturers to deploy, manage and monitor production processes and performance within a 

single plant or across the enterprise or extended supplier network. 

Because the Apriso solution is highly adaptable, while also enforcing strict compliance and 

best-practice processes, it allows life sciences manufacturers to easily vary processes to meet 

differing regulatory requirements, while still getting to market quickly and competitively. 

This next generation MES solution is built on Apriso's adaptive FlexNet platform, which the 

company has already deployed successfully in both single- and multi-site implementations for 

many of the world’s leading manufacturers. To this flexible platform for manufacturing 

operations management, Apriso has added three separate but fully integrated modules that 

support the key manufacturing requirements for plant control, data reporting and analytics 

across the enterprise: 

� Global Process Manager – Facilitates fast, reliable deployment and management of 

process flows within a facility, an enterprise, and across supply networks; manages 

multiple FlexNet configurations to ensure system synchronization across distributed 

manufacturing computing environments. 

4 

"Why Manufacturers Are Investing in Plant Floor IT Systems," by Greg Gorbach, ARC Advisory Group, 

April 13, 2006 


� Global Production Manager – Tracks and traces materials and products across the 

manufacturer’s enterprise and those of suppliers and contract manufacturers; 

� Global Performance Manager – Built on a robust KPI analytics engine, provides 

detailed visibility into production status, product attributes, SPC and quality for 

resources, material, labor and machines, both locally and across multiple locations. 

Life sciences manufacturers can now: 

� Easily vary processes to meet the regulatory requirements of different regions 

� Support diverse manufacturing methodologies, geographies, cultures and markets 

� Handle changing product lines, processes and standards 

� More efficiently operate business systems by filling the “white spaces” where ERP 

systems have not been able to reach 

� Track, trace, manage and control best-practice processes across multiple-sites 

A Comprehensive Solution for 

Life Sciences Manufacturers 

The Apriso Global Manufacturing Suite provides life sciences manufacturers, for the first time, 

with a total view of, and control over, their diverse manufacturing operations, including 

warehousing, time and labor, quality management and asset maintenance. 

It enables implementation of ARC Advisory Group’s Collaborative Production Management 

(CPM) model and ISA S95 model - each of which extends beyond traditional MES. More than 

just a production system, Apriso's Global Manufacturing Suite encompasses supply chain 

execution and collaborative manufacturing – from receiving dock, suppliers and contract 

manufacturers on one side, to shipping dock and customers on the other side. 

The Apriso solution enables paperless DHR and BR enforcement of processes across 

operations, as well as full reporting of actual execution results back to ERP systems of record. 

It provides management visibility and control over all the sub-systems shown in Figure 1 (with 

the exception of Design Controls, which are properly managed through a PLM system). 

6 A Competitive Approach to Regulatory Compliance in Life Sciences Manufacturing 

The Apriso Global 

Manufacturing Suite 

provides Life Sciences 

manufacturers, for the 

first time, with a total 

view of, and control 

over, their diverse 

manufacturing 

operations, including 

warehousing, time and 

labor, quality 

management and 

maintenance.

Design 

Controls 

Material 

Controls 

Corrective & 

Preventative 

Actions 

Management 

Records, 

Documents & 

Change 

Controls 

Figure 1: Manufacturing sub-systems of Life Sciences manufacturers 

Production & 

Process 

Controls 

Equipment & 

Facility 

Controls 

With Apriso's Global Manufacturing Suite, life sciences manufacturers are able to: 

� Define and deploy compliant processes anywhere. Global Process Manager provides 

the ability to actively manage processes and best practices to ensure consistency and 

compliance at all facilities. Supervisory personnel can define and perfect processes 

in one location and deploy them instantly to multiple sites and geographies 

throughout their operations, and those of suppliers and customers. The system has 

full revision control and accelerates new product introduction and time-to-volume 

production by integrating with third-party PLM/PDM systems, and managing 

operational data across the supply network. 

� Maintain a single version of the truth. Global Performance Manager creates 

consistent KPI standards for every location, so every plant measures information 

accurately and the same way. Then, the software rolls the real-time information up to 

the business level where executives can make real decisions, based on real 

information, and take immediate action. 

� Gain a complete view into product history. Global Production Manager provides 

companies with a global, real-time view into manufacturing operations and those of 

suppliers. The software gives complete work-in-progress production visibility and 

traceability across sites and multiple companies, with full material synchronization 

and manufacturing bills of material (MBOM) and/or formulations. The configurable 

visual controls make it much easier to drive business process improvement and 

compliance initiatives. The system has full alert and dashboard features and can 

record and manage deviations and exceptions across the supply chain. 


The Power to Act 

Perhaps most important of all, Apriso's Global Manufacturing Suite empowers executives to 

take action—not just to set objectives, but to drive those objectives down to the plant floor. 

Apriso's Business Process Management (BPM) software allows “smart work instructions” to be 

authored as business processes that can be enforced by the system. The authoring of the 

processes automatically renders a user interface which directs operators step-by-step through 

the work instructions, reducing variability and errors in execution and enabling Six Sigma 

processes. 

The Return on Investment 

The benefits of a global approach to operational excellence go beyond compliance with 

regulations. An Aberdeen study found that companies taking steps to standardize KPIs and 

close the gap between ERP and the plant floor reported significant improvements in 

operations, including: 5 

� Decreased costs 

� Improved customer satisfaction 

� Improved control of manufacturing 

� Improved visibility into plants/factories 

� Faster order-to-delivery 

Get There One Plant at a Time 

While most analysts and best-in-class companies embrace the need for a global approach to 

MES, the reality is that companies will need to phase in new systems over time. 

Companies can implement Apriso’s FlexNet operations execution platform tactically to ease an 

immediate pain point, or broadly and strategically to seize a global competitive advantage. In 

all cases, the Apriso platform's modular architecture allows life sciences manufacturers to add 

capabilities quickly and easily down the road. 

5 

"Global Operational Excellence Benchmark Report: MES and Beyond," Aberdeen Group, May 2006 


While most analysts 

and best-in-class 

companies embrace the 

need for a global 

approach to MES, the 

reality is that companies 

will need to phase in 

new systems over time.

Conclusion 

Life Sciences manufacturers are designing and manufacturing increasingly complex product 

with reduced market windows—while at the same time meeting a variety of regulatory 

requirements both domestically and internationally. 

In the past, companies have relied on Manufacturing Execution Systems (MES) to control plant 

floor operations and maintain compliant processes. As market pressures accelerate, however, 

companies are finding that their current MES is too inflexible and rigid to cope with the realities 

of today's life sciences marketplace. 

Apriso's manufacturing operations management solution performs as a next generation MES 

platform, moving beyond the capabilities of a traditional MES. The solution provides a single, 

unified view of all manufacturing activities by synchronizing multiple systems via a single 

platform for managing and deploying compliant processes anywhere in the world. 

This allows life sciences manufacturers not only to reduce risk of compliance violations and 

quality failures, but also to proactively manage quality throughout their operations to gain 

competitive advantages in quality, cost and time-to-market. The end result is improved 

business performance and improved regulatory compliance. 


About Apriso 

Apriso Corporation is a software company dedicated to providing competitive advantage for its 

customers. It does so by enabling organizations to adapt quickly and easily to market changes 

and unexpected events. Since 1992, Apriso has been helping companies improve 

manufacturing performance by providing visibility into, control over and synchronization across 

manufacturing operations – both within and in coordination across –plants and the product 

supply network. Some of the world’s largest and most successful manufacturers have 

leveraged Apriso’s unique combination of software solutions and expertise to transform their 

manufacturing operations to achieve and sustain manufacturing excellence. 

As an adaptive platform for manufacturing operations management, FlexNet manages 

production, quality, warehouse, maintenance and labor processes to provide visibility into, 

control over and synchronization across global manufacturing operations. Built with a native 

Business Process Management (BPM) framework that incorporates a unified data model, 

FlexNet applications enable continuous improvement and rapid response to market changes. 

FlexNet delivers a global view of manufacturing operations by utilizing a Service Oriented 

Architecture (SOA) to ease integration with enterprise applications, such as ERP and PLM, 

while interfacing with the shop floor and automation equipment. 

Apriso serves 180+ customers in 40+ countries across the Americas, Europe and Asia. Its 

customers include General Motors, Lear, Honeywell, L'Oréal, Trixell, Lockheed Martin, Becton 

Dickinson, Saint-Gobain, Novelis and Essilor. For more information, please go to 

www.apriso.com. 


www.apriso.com

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