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Pharmaceuticals & Biotechnology


As one of the most highly regulated industries in the world, pharmaceutical and biotechnology companies are held to very high quality and standards. To succeed, they must have systems designed to keep pace with the ever-changing scenarios within the industry.

SoftExpert offers the industry's most advanced and comprehensive software suite for compliance and quality management that meets the unique needs of the pharmaceutical and biotechnology industry in all aspects from managing product lifecycle to performance indicator monitoring, process optimization and much more.

SoftExpert Excelence Suite lowers the cost of regulatory compliance and helps companies maximize success, increase productivity, reduce risk and adhere to various regulations.

The solution enables pharmaceutical and biotechnology organizations to map, analyze and continually improve the efficiency of operations by integrating in a single platform of different management frameworks, including product development management, regulations, strategy, processes, performance, customers, documents and records, quality, risks and assets.

By offering staff with insight in their role in end-to-end activities, they become better able to recognize opportunities for improvement rather than ending up fighting fires. Powerful support for collaboration with co-workers across organizational boundaries then enables them to play a central role in making smart improvements in the way the organization serves its customers.

SoftExpert Suite simplifies and standardizes excellence and compliance management processes by providing a software platform with a central point of access to all up-to-date process documentation, process KPI's, related documentation such as policies, templates, procedures and task related applications, as well as an online platform for registering suggestions, risks, complications and initiatives.


We are very satisfied with the clear improvements in our processes. The reliability we achieved with the validation tool makes us feel safe and confident that we are following all of the requirements from the standards that we abide by.

Patricia Battonyai - Quality Operations Manager -
Intervet | Schering-Plough Animal Health


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Project Planning
Balanced Scorecard
Strategic Planning
Risk Evaluation
Manufacturing Process Management
Product Development Structure


  • Manage corporate performance from strategic to operational level
  • Increase regulatory compliance
  • Reduce operational costs
  • Improve operational efficiency
  • Instantly share quality and performance data across the enterprise
  • Maximize costly resource investments
  • Standardizes and streamlines pharmaceutical and biotechnology processes
  • Ensures conformity with standards and regulations
  • Ensures on-time reporting and periodic reporting via dashboards, alerts, and notifications
  • Identify, analyze, evaluate, monitor and manage risks by automating safety surveillance and signal identification processes
  • Tracks reporting non-conformances into the quality management process for investigations and corrective actions.

About SoftExpert

SoftExpert is a market leader in software and services for enterprise-wide business process improvement and compliance management, providing the most comprehensive application suite to empower organizations to increase business performance at all levels and to maximize industry-mandated compliance and corporate governance programs.

Founded in 1995, SoftExpert has a rich history of innovation and growth as a true industry leader. More than 300,000 users from 2,000 organizations worldwide trust SoftExpert applications to ensure the highest standards of efficiency, quality and innovation for their products, services and processes.

By streamlining and integrating all levels and operations, SoftExpert applications also enable organizations to address an ever-increasing variety and number of international standards, laws and regulations that affect business operations by delivering enhanced compliance capabilities based on industry-specific best practices.

SoftExpert solutions are used by leading corporations in all kinds of industries, including consumer products, automotive, food and beverage, mining and metals, high tech and IT, energy and utilities, government and public sector, financial services, transportation and logistics, healthcare, education, medical devices and many others.

Along with its extensive network of resellers spread across all continents, SoftExpert also provides hosting, implementation, post-sales support, and validation services for its solutions to ensure that customers realize the maximum value from their investments.

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