Syntex solutions for the Life Sciences industry helps better manage risk and regulatory compliance and supports business processes for key Industry segments, including:
- Pharmaceuticals – Improve worker and product safety & quality, identify and mitigate risk, manage compliance, and optimize performance management in delivering new, complex and innovative products.
- Biotechnology/biopharmaceuticals – Help attain and sustain compliance with FDA and other regulations by automating and managing operational processes, identify and mitigate risks, and improve management of safety, reliability, and quality of the product.
- Medical device/scientific instruments – Improve product safety and quality, manage compliance and help reduce operational costs and improve margins.
Types of Life Sciences companies that use Syntex IMPACT Enterprise
Pharmaceuticals
Syntex products and services help Pharmaceutical companies facing:
- Extensive regulatory oversight by the U.S. Food and Drug Administration (FDA) and other levels of regulation
- Effective patent protection being an essential component due to high cost and time for drug approval
- Competition for discovering new drugs and bringing them to market is extremely high
- Significant portion of sales is reinvested in R&D and discovery of new compounds
- The safety of workers who work with volatile materials and end product
- Increased security concerns of plant, reputation and more
Biotechnology & Biopharmaceuticals
Since products are regulated according to their intended use and often regulated by more than one agency, the level of regulation is extremely complex and voluminous. Syntex helps Biotech and biopharmaceutical firms that:
- Contend with pressure to deliver new, complex, innovative products
- Must work under an extreme level of regulation
- Work with volatile materials and end product
- Face constant risk to personnel and plant
- Today face additional security concerns
- Require highly educated, highly paid work force
- Must rely on contractors
- Require special equipment to manufacture, store and transport
- Face strong local oversight
- Face increasing public relations pressures
Medical Devices & Scientific Instruments
Staying on top in this highly competitive industry is more than challenging, it can be life or death of a company—making continuous process improvement from conception to market is vital for business success. The industry being amongst the most heavily regulated industries today, must also contend with stringent regulations on a global-wide basis. Syntex's software solutions help medical device and scientific instruments firms that:
- Face pressure to deliver new, complex, innovative products
- Stretch capabilities to address cyclical end-user markets on time-to-market
- Must work under an extreme level of regulation
- Work with volatile materials and end product
- Face constant risk to personnel and plant
- Today face additional security concerns
- Control complex equipment and processes that create exposure to risk
for
- Employees
- Assets
- Environment
- Product
- Company Reputation
Ways that Life Sciences Companies use IMPACT ERM
Regulatory Compliance
Regulations for Life Science companies are extremely complex and interdependent making regulatory compliance more difficult to manage. IMPACT ERM® Suite software assists Life Science companies in their compliance initiatives. It helps to facilitate inspections, audits, findings and analysis by delivering to management a high level of crucial and actionable information, improving the responsiveness and measuring the effectiveness.
Operations Management Systems
IMPACT ERM Suite enterprise risk management system helps Life Sciences companies facilitate the management of system
elements, compliance, continuous improvement, communication, analysis
and reporting around a variety of management systems and excels in enabling
the execution of these programs. Some sample management systems include:
- Responsible Care®
- Voluntary Protection Programs (VPP)
- Sarbanes-Oxley (SOX)
Data Collection & Reporting
IMPACT ERM facilitates data collection and reporting through easy-to-use interfaces delivered via the Web. It brings immediate value through consolidation of disparate management systems and other systems while storing data into a single-integrated database. Company employees and contractors can use simple forms to enter data even in remote locations, while leadership and decision makers easily analyze information to address potential or existing risks across the enterprise.
Business Value for Life Sciences Companies
Measure, manage, and mitigate risk.
IMPACT Enterprise delivers capabilities for operations planning, incident, assessment, quality and environmental management, regulatory compliance assessment, and other risk management. Integrated communication and workflow processes non-intrusively engage leadership and workforce in reactive as well as proactive risk identification and execution of action items to help strengthen risk reduction systems. Life Sciences companies of any size can rapidly and affordably deploy a standardized set of business processes based on industry best practices.
As these processes propagate safer, more efficient practices throughout the enterprise, quality and productivity increase. These factors are generally where the highest profit margins are found.
Understand patterns of operations and performance.
IMPACT Exec Analytical & Reporting Tool provides sophisticated analysis, reporting and scenario development tools. These help Life Sciences companies analyze past experience to more accurately predict future requirements or gaps within the performance management system. Gaps and requirements become clear – such as regulatory non-compliance or potential for loss. Your system then engages all employees in prioritization of remediation and execution of action items.
We Understand Local Regulations and Requirements
Life Sciences is an integral part of the Chemical Industry. The growth in the Chemical Industry has been focused in the basic chemicals (petrochemicals) segment, which is concentrated along the Gulf Coast, where petroleum and natural gas feedstocks are readily available. The Gulf Coast area produces the majority the industry sector chemicals, with Texas and Louisiana producing about 70 percent of all primary petrochemicals.
Syntex is a Texas, Gulf Coast company and we have a long and successful working history with some of the biggest players in the Chemical and Petrochemical industry (ExxonMobil, PPG Industries, Shell Oil, Atofina and Lyondell Chemical to name a few). Many of our customers have facilities located along the Gulf Coast area, but our experience with them and the Chemical Industry extends beyond local geographical boundaries to across worldwide markets and multiple business domains. Many industries, such as Life Sciences, are adopting our solution to engage their workers in identifying, prioritizing and mitigating risk. We have an understanding of local and global industry regulations, business requirements and government expectations. We also know that environmental and other regulatory compliance is a basic tenet of your business responsibilities. In fact, it is integral to your business planning and operating practices — striving to continuously improve QHSE performance is a primary goal.
Summary
For Life Sciences companies, the risk could hardly be higher: Toxic and volatile substances, complex machinery and processes, product quality issues, critical transportation issues, security concerns and of course, the human element.
Today, Life Sciences companies must also conduct and manage daily operations across far-flung enterprises. They must deal with globalization, regulatory compliance, heightened environmental pressures, mergers and acquisitions, and ever-changing business and market conditions. All of this combines to make operational risk management increasingly difficult.
These are precisely the reasons why Life Sciences companies around the world that are among the most dedicated to reducing risk and improving safety have chosen to deploy the IMPACT Enterprise® solution for enterprise risk management.
Contact a Syntex Life Sciences specialist
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