Pharmaceutical and biotechnology industries are under constant pressure to meet rigorous regulatory requirements imposed by regulatory agencies such as the FDA and EU. Globalization, increasing complexity of diseases, introduction of new technologies, and new demands from the market, make the regulatory environment to change continuously.
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 and process optimization.
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.
SE 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.
Principais benefícios da solução
Manage corporate performance from strategic to operational level.
Increases regulatory compliance, through electronic document draft and approval, management of printed copies and audit trail.
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.