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 most complete software for the pharmaceutical industry, fulfilling every aspect of this sector’s specific needs, from product lifecycle management to monitoring of performance indicators and process optimization, simplifying compliance and quality management.
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 them in a single platform of different management frameworks, including product design, regulatory affairs, adverse events, change management, electronic batch records (EBR), and supplier management, among others.
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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Document Control
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Performance Tracking
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Project management
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Risk evaluation
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Processus de fabrication
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Gestion des données de production
Основные преимущества
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.
Solution Overview
Solution Overview
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Рекомендуемые источники
Электронная книга
How to achieve Operational Excellence in the Life Sciences Industry
Read this eBook to find out the eight pillars to help life sciences companies overcome barriers to excellence.
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Imperative for managing risk in pharma
How to effectively manage the corporation’s reputation embedding risk management in their normal business practices.
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Process Validation: How many sample sizes do I need?
The several factors that must be considered when determining the appropriate sample size for process validation.
