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Life Sciences
Industry Challenges Addressed
The ROSS
suite of solutions from Ross Systems and our specialized consulting
services are designed to address the unique challenges you face
in the life sciences industries. These include:
Recall Protection/Risk
Mitigation
The present-day threats and potential costs associated with recalls
have never been higher. One recall can put you out of business.
As companies seek to increase their control and in turn, minimize
the risks, they discover that many varied activities, both within
an outside the organization, must be considered. Operations up and
down the supply chain must all be addressed.
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ROSS
helps you monitor, track and control your critical resources
including activities and materials. Capabilities in
the areas of end-to-end traceability provide flexibility
to follow complete histories and audit trails, forward
and backward, across the supply chain. Specification
management and change management also provide the control
and predictability to detect and address variability
early in your process. When potential issues are identified,
you can quickly determine the underlying cause, make
the necessary corrections and provide supporting documentation.
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Regulatory Compliance
Biotechnology and pharmaceutical companies are held to increasingly
stringent standards, through regulatory agencies like the Medicines
Control Agency (MCA) and the U.S. Food and Drug Administration (FDA)
and by the industry itself. Regulations and enforcement particularly
in areas such as Good Manufacturing Practices (GMP) and more specifically
21 CFR Part 11 can significantly increase overhead costs. The resulting
challenges then become magnified How do you minimize the risks
of non-compliance while keeping your operational costs down to maximize
profits and enable growth?
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ROSS
reduces the efforts, costs and risks created by compliance
with governmental and industry regulations. From your
planning activities to your execution and documentation
of results, ROSS automates many critical functions.
All standard processes are documented and all operations
and results are tracked and logged to support your detailed
reporting requirements. Specify how a product is manufactured.
Manage variability. Maintain product genealogies. View
inventory in multiple units of measure simultaneously.
Support double-blind entry and electronic approvals.
These are just a sampling of how ROSS addresses
the regulatory requirements you may be facing. In the
end, ROSS streamlines, and reduces the cost
of your compliance efforts by providing the visibility
and control you need.
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Product and process
quality control
Life sciences manufacturers are expected to implement quality standards
among other good manufacturing practices (GMP). Ensuring that quality
guidelines are not only followed, but also are consistently achieved
is problematic for many companies. The ability to manage, capture
and track quality information across the production process and
supply chain is fundamental to this effort. More important, however,
is to be able to recognize and take action on early warning indicators
for out-of-spec issues.
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With
ROSS, you can address all of these requirements.
Adjust recipes and formulas dynamically based on material
characteristics so that you maximize material utilization
and ensure the consistent quality and accuracy required
in life sciences manufacturing. You can also streamline
creation of new recipes and formulas utilizing same-as-except
capabilities used to copy similar recipes, with changes
limited to exceptions.
You can
exact control over all materials and products (co/by/end)
throughout the process (i.e. formulation) and be more
diligent in batch scaling, date code tracking, shelf-life
expiration dating lot tracing and yield optimization
among other capabilities.
Because
ROSS is designed with quality control (QC) and
quality assurance (QA) as in integral part of the process
quality can be planned and managed just like any other
process. This enables you predefine and measure customer
quality specifications among other attributes at critical
steps in the process.
ROSS
also tracks lot characteristics and quality control
tests which can include microbiological and chemical
results. At the time of shipment, you can be confident
that your products meet internal, regulatory or customer
quality tolerances and expectations.
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Increased costs
and reduced margins
Growing revenue pressures compel life sciences companies to streamline
production and distribution operations. Wringing costs out of these
processes must be balanced with maintaining margins to support operations
especially cash-intensive operations like R&D. With visibility
across all areas of the organization from finance to manufacturing,
companies can begin to fully understand and address how certain
practices impact margins and bottom-line profitability.
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ROSS
provides the company-wide visibility through integrated
information and capabilities to speed the flow of goods,
eliminate waste due to costly shelf-life expirations
and returns, and gain the efficiency necessary to meet
product demand while keeping costs at a minimum. As
an example, support for actual costing exposes all material
and operation costs, including indirect costs or value
resulting from co-products and by-products so you can
better understand how margins are affected and to what
degree.
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Satisfying Customer
Needs and Demands
Retaining existing customers and winning new ones is becoming increasingly
more complex. Learning their needs, understanding their preferences,
and anticipating what they might need next are the only ways to
strengthen relationships and build the customer base. Customer relationship
management (CRM) is a business strategy that leverages people, process
and software in an organized way to help life sciences companies
manage the complete customer lifecycle from selection to retention.
With a carefully planned CRM strategy, management, sales, marketing,
customer service, and even partners and clients should be able to
share information such as customer purchases or needs and matches
for product or service offerings.
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ROSS
empowers you manage interactions throughout the customer
lifecycle. With a common tool and centralized information
repository across applications that touch your customers
(i.e. sales, marketing, support) with your operational
systems (financial, inventory, supply chain), you can
focus on taking care of your customers. Link your selling
chain to your supply chain. Build the loyalty of existing
customers. Make it easer to attract new ones.
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Increasing Competition
Up and Downstream/Time-to-market
The intensity and diversity of the life sciences competitive landscape
is unprecedented. For the biotechs, threats may originate from upstarts
and generic drug makers. These unanticipated competitors challenge
established R&D-driven companies to speed time-to-market in
time so they can adequately recoup investments. Pharmas face the
emergence of buying groups and the expansion of HMOs. The trend
toward business alliances including mergers and divestitures, partnerships
and other cooperative ventures, constantly reshapes the landscape.
This ongoing reorganization undermines traditional sales channels
and increases pressure for cost cutting measures.
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ROSS enables biotechs and
pharmas to optimize product service and value, deliver
high-quality products on time, meet customers and regulatory
requirements, increase operational efficiencies throughout
the enterprise, and embrace and leverage opportunities
for business change. All of these areas are critical
to compete effectively and continually grow your business
as market demands shift and requirements change.
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