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 (SE 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.
Pharmaceuticals & Biotechnology
-
Project Planning
-
Balanced Scorecard
-
Strategic Planning
-
Risk Evaluation
-
Manufacturing Process Management
-
Product Development Structure
Main Benefits
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.
Featured Resources
ISO 13485 – Medical devices quality management systems
The key clauses of ISO 13485 and the business benefits of quality management in the medical devices industry.
Imperative for managing risk in pharma
How to effectively manage the corporation’s reputation embedding risk management in their normal business practices.
União Química
Pharmaceutical company União Química integrates systems, improves processes and manages over 3,000 documents using SoftExpert solutions