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.
Pharmaceuticals & Biotechnology Solution
SoftExpert Excellence 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.
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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.
Principali benefici della soluzione
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.
Overview della soluzione
Materiali in rilievo
Imperative for managing risk in pharma
Process Validation: How many sample sizes do I need?