If you receive errors when attempting to view this white paper, please install the latest version of
Adobe Reader.
"Founded in 1972, SAP has a rich history of innovation and growth as a true industry leader. SAP currently has sales and development locations in more than
50 countries worldwide and is listed on several exchanges, including the Frankfurt Stock Exchange and NYSE
under the symbol SAP."
Source : SAP
Compliant Manufacturing Operations in Life Sciences Companies: Compliant Operations to Lead the Competition
Manufacturing Operations is also known as :
Manufacturing Operations,
Manufacturing Operations Concern,
Integrated and Seamlessly Operating MFG Plant,
Research Report on Operations Manufacturing,
Controls Manufacturing System,
Manufacturing Operations Strategy,
Manufacturing Operations Enable,
Consistent Operations,
Realignment of Manufacturing Operations,
Termination of Manufacturing Operations,
Leadership in Manufacturing Operations,
Best-in-Class Operations,
Manufacturing Operations Enabling Visibility,
Optimising Manufactuirng Operations,
Find Manufacturing Operations,
Consumer Goods Manufacturing Operations,
Manufacturing Operations Management,
Manufacturing Operations Challenges,
Manufacturing Operations Achieve Operational Excellence,
Manufacturing Operations Solutions,
Production Manufacturing Operations,
Relating to Manufacturing Operation,
Safe Manufacturing Operations,
Manufacturing Operation Resources,
Manufacturing Operations Enabling,
Manufacturing Development Operations.
Global competition, more-demanding
patients, new regulations, and high
development costs are driving life
sciences companies to deliver higherquality
products at ever-lower costs.
Executives worldwide must find new
ways to deliver quality products to
customers consistently and meet good
manufacturing practices (GMP) regulations
at the lowest cost possible.
For many life sciences organizations,
a key impediment to compliant manufacturing
operations remains the disconnect
between enterprise and plant systems.
This results in unsynchronized business
processes and inadequate use of resources,
which in turn increases the
risk of noncompliance, inadequate quality
of finished products (with potentially
life-threatening implications), and lower
performance from people and processes.
Simply connecting systems will not fully
overcome these challenges. World-class
life sciences companies are going further,
integrating and aligning core processes
to achieve transparency between the
plant floor and the enterprise across even
the most widely distributed manufacturing
operations. This approach enables
you to monitor, measure, analyze, and
control performance deviations in real
time – across processes, plants, and
personnel. This, in turn, ensures consistent
levels of quality and compliance and
higher overall equipment effectiveness,
while driving down bottom-line costs and
cycle times.
Yet even with these gains, there remains
more work to do to run compliant manufacturing
operations in a competitive –
and increasingly regulated – marketplace.
Quality and genealogy need to be documented,
tracked, audited, and reported
for compliance with stringent regulations.
Life sciences companies need to find
ways to reduce both the costs of compliance
and the risk of noncompliance
while continuing to increase operational
efficiency.
How can you achieve these goals? With
integrated software and world-class
services from SAP and our partners.
Deliver High-Quality Products
Consistently to Customers
For many life sciences companies there
still exists a huge gap between the enterprise
and the plants. That disconnect
prevents visibility into operations and
creates inefficiencies that make it all
but impossible to adjust plans quickly
in response to changes in customer
orders and production mix. Additionally,
information latency can cause poorly
coordinated manufacturing activities,
supplier and delivery delays, quality and
compliance exceptions, and ultimately
a decrease in customer satisfaction.
Integrated software from SAP can help
you bridge this gap by connecting your
enterprise and plants – whether in one
location or around the world. Such connections
create the visibility required to
run compliant manufacturing operations.
You are better positioned to coordinate
globally while executing locally, plan
effectively, and execute efficiently on the
plan. You can plan production in alignment
with business objectives, manage manufacturing
and supply constraints, and
maintain inventory levels in keeping with
service levels. Moreover, with software
from SAP you can monitor and analyze
the factors affecting lead times and
respond more quickly to changes in
customer orders so as to meet customer
delivery commitments for high-quality
products consistently.
Ensure Compliance with GMP
For a life sciences company, compliance
with GMP and validation of that compliance
is critical to the development and
delivery of quality products and responsible,
sustainable corporate profitability.
Whether at the product level or the process
level, regulatory noncompliance
can affect your company through fines,
penalties, negative publicity, loss of
customers, or the prohibition against
selling your products in the market.
Manufacturing controls play an essential
role in meeting those compliance requirements.
Integrating such controls within
your operations can help you reduce
safety risks even as they help you
improve product quality.
Software from SAP can help you comply
with, document, and validate requirements
for GMP and manage these by
exception. For example, workflow tools
within SAP® applications can help you
drive inspection processes and enable
corrective action, including quarantining
specific components, if necessary, and
issuing quality alerts through supplier
Web portals. The software can even
provide tracing and reporting functionality
to help you analyze root causes
for compliance failures.
SAP partners can extend support for
manufacturing controls even further. By
connecting third-party applications with
your SAP software, for example, you
can track hazardous substances, exposures,
packaging, dangerous goods
classifications, and waste codes. This
can help reduce the number of defective
or noncompliant products as well
as reduce the costs associated with
such noncompliance.
Reduce Costs of Manufacturing
Operations
At the plant level, on a day-to-day basis,
it is critical to manage production and
materials optimally, according to plan.
Inefficiencies on the top floor, though,
can lead to operational inefficiencies on
the shop floor. A poor-quality plan, for
example, can lead to infeasible production
schedules, wasteful activities, and
excessive inventories – all of which
contribute to higher operating and
inventory costs.
SAP provides integrated software and
services that can help you optimize
production planning and scheduling
across your globally distributed manufacturing
operations. You can use this
software to integrate and standardize
production operations as well as manage
plant-floor activities in real time and
at levels that support your Six Sigma
strategy. With complete support for
Six Sigma initiatives, just-in-time (JIT)
processes, and other continuous
improvement efforts, you can optimize
day-to-day operations, eliminate waste,
reduce operating costs, and lower
inventories to ensure sustained operational
performance.
Consider this: Using decision-support
tools that enable you to simulate and
compare alternative manufacturing
scenarios, you can more easily match
production rates to optimal production
targets. You can map production activities
to customer orders more effectively,
taking material, capacity, and labor
constraints into consideration when
prioritizing your activities. Life sciences
software from SAP partners can extend
these benefits still further. You can lower
your operating costs, for example, with
integrated software that supports your
weigh and dispense activities. Furthermore,
you can manage inventory levels,
capacity constraints, and resource
allocation to minimize queues. SAP
software can also help connect the
plant floor to the enterprise at the
lowest cost of ownership. This enables
effective management of production
execution by generating feasible and
executable schedules that take into
account bottleneck information based
on real-time visibility.
Software and Services for
Compliant Manufacturing
Operations
Integrated software and services from
SAP and our partners can provide
you with the functionality you need to
manage compliance across the entire
plan-to-produce scenario. These include
your key business processes for enterprise
planning and control, plant-level
operations, manufacturing intelligence
and collaboration, manufacturing execution,
product quality, safety and environmental
compliance, and Six Sigma.
Several applications comprise this
integrated solution.
The SAP ERP application helps you
streamline your compliant manufacturing
process – from planning and scheduling
through sequencing and execution to
monitoring and analysis – and improve
efficiency along your entire value chain.
The SAP Supply Chain Management
(SAP SCM) application enables collaboration,
planning, execution, and coordination
of the entire supply chain
network.
The SAP Lean Planning and Operations
(SAP LPO) application extends the
value of SAP manufacturing solutions by
providing lean planning and scheduling
functionality for plant execution.
The SAP Manufacturing Integration
and Intelligence (SAP MII) application
provides the direct connection between
business operations and shop-floor
systems. It ensures that all data that
affects manufacturing is visible in real
time – including information about orders,
materials, equipment status, costs, and
product quality. The application also
delivers manufacturing visualization
tools, analytics tools, and reports that
empower decision making and support
your continuous-improvement initiatives.
The SAP Manufacturing Execution
application by Visiprise provides a
powerful means for managing production
and ensuring compliance across medical
device manufacturing operations. Integrated
with your SAP ERP software,
the application facilitates the flow of
information between the production
floor and the rest of the enterprise.
The PAS-ECMI application from Werum
Software and Systems integrates with
SAP ERP and SAP MII to help pharmaceutical
companies meet regulatory
requirements and increase operational
performance. The modular software
package supports best-practice business
processes for biopharmaceutical
manufacturing operations – for example,
weighing and dispensing – as well as
monitoring and tracking of all critical
business procedures out of the box.
Working together, these integrated
applications can help you align manufacturing
operations and resources
between the core enterprise and plants
and achieve high compliance from end
to end with:
- Complete visibility across manufacturing
operations in a multiplant
environment
- Streamlined operations from the plant
floor to the enterprise
- Integrated quality and safety controls
- Compliance with GMP
Underlying these integrated applications
is the SAP NetWeaver® technology
platform. SAP NetWeaver unifies technology
components into a single platform,
providing the best way to integrate all
systems running SAP or non-SAP
software.
In addition, the SAP Services organization
can help assess your manufacturing
processes and present a clear road map
toward excellence in compliant manufacturing
operations. Using best business
practices developed during more than
105,000 business engagements in 120
countries, SAP Services can help you
keep your manufacturing operations
running at peak compliance levels in
support of your business goals.
An End-to-End Solution for
Operational Excellence
With integrated software from SAP,
you can:
- Consistently deliver high-quality
products
- Ensure compliance with GMP
- Reduce costs of manufacturing
operations
For More Information
To learn more about how integrated
software from SAP can help your organization,
call your SAP representative
today or visit us on the Web at
www.sap.com/solutions/executiveview
/operations/run-efficient-manufacturing.
Summary
With compliant manufacturing operations, life sciences companies can deliver quality products
to customers consistently and meet good manufacturing practices (GMP) regulations at
the lowest cost possible. Software and services from SAP and our partners can help you
bridge the gap between your core enterprise and plant-floor systems at the lowest total
cost of ownership.
Challenges
- Inconsistent levels of quality and compliance
- Lack of visibility across manufacturing operations
- O perational inefficiencies across the plant floor and the enterprise
Supported Business Processes and Software Functions
- Enterprise planning and control – Establish an achievable master plan aligned with
customer requirements and business objectives and constraints, and control
manufacturing activities across all plants
- Plant-level operations – Plan and manage manufacturing lines, schedules, and resources
on a daily basis
- Manufacturing execution – Execute production according to schedule while considering
exceptions and deviations in real time
- Manufacturing intelligence and collaboration – Gain insight into manufacturing activities
and performance while ensuring collaboration across your plants and those of contract
manufacturers
- Product quality, safety, and environmental compliance – Ensure that your products and
processes comply with GMP
- Lean and Six Sigma – Manage manufacturing activities at Six Sigma levels and benefit
from complete support for lean initiatives
Business Benefits
- Consistently deliver high-quality products
- Ensure compliance with GMP
- R educe costs of manufacturing operations
For More Information
Call your SAP representative or visit us online at
http://www.sap.com/solutions/executiveview/operations/run-efficient-manufacturing.