Regulatory, Compliance and Quality Management Solutions for Pharmaceutical and Biotechnology Organizations

Total Quality

Total Quality for a single source of truth, data integrity, Quality and Business Excellence

For any organization delivering products and services to customer and patients quality is as important as never before. Quality helps ensuring patient safety and efficacy of their treatments, it helps customer satisfaction and brand loyalty, it helps sustainability and environmental friendliness and it helps protecting the reputation of an organization.

With these aspects in mind advanced organizations have moved from mere regulatory compliance adhering to regulations such as those published by the US Food and Drug Administration (USFDA), the European Medicines Agency (EMA), Japan’s Pharmaceutical and Device Agency (PDMA) or the International Organization for Standardization (ISO) to a Quality-centric approach. They make Quality an integral part of every process throughout the entire product lifecycle, implement Quality by Design (QbD) early on in development and create a Culture of Quality. This approach is highly endorsed by the FDA.

They design and rework their processes with Quality in mind, which will not only improve Quality but will also result in more efficient processes. When organizations make Quality a part of their culture and Quality becomes “Total Quality” and encompasses all departments of an organization from Research over Development to Manufacturing and Commercialization, it will simultaneously improve efficiency and reduce compliance risks and costs. Organizations will achieve Quality Excellence leading to Operational and Business Excellence.

Technology and Digitalization can be the enablers for Total Quality. The integration of Quality-related capabilities on a flexible business platform will ensure digital continuity providing data integrity and a “Single Source of Truth” of information, enable a vertical and horizontal data flow throughout the product lifecycle and support data exchange and collaboration.

Customers reported:

  • 50% reduction in FDA on-site inspection time
  • 80% reduction approval times
  • 90% reduction in time taken to generate APR’s
  • Reduction in root cause investigation time from 1 month to 1 hour
  • 10% to 15% improvement in productivity at the commercial manufacturing scale

Key capabilities include:

  • Data-centric, intelligent Enterprise Content Management and Control according to Industry Standards
  • Learning Management with automated processes
  • Enterprise Quality Management and Quality Process Management for CAPAs, deviations, audits, validation, customer complaints and other events management processes and multi-site change control
  • Quality Intelligence for better access to Quality information and support of impactful knowledge-based decisions
  • Process and Quality Metrics for better process understanding and control and process design, supporting QbD implementation
  • Scientific Data Management to further investigate the results generated in Quality Control (QA/QC) labs

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