Pharmaceuticals & Biotech

The Challenge
Pharmaceutical and Biotech companies face significant challenges in cost-effectively meeting growing regulatory requirements while innovating new medicines to improve patient health. Complying with regulatory bodies like FDA and EPA and regulatory standards such as ICH, GMP, ISO and OSHA increases time-to-market and requires increasing levels of effort. The cost to develop new drugs increased by 60% from 2001 - 2006 with only a small percentage of new marketed products ever returning their initial R&D investment. At the same time, generic drugs have been eroding branded drugs market share - a 33% increase from 2003 to 2008. Government and healthcare provider policy changes to reduce costs have been a major factor in this trend, in addition to expiring branded drug patents.

The Biopharmaceutical industry challenge is to streamline the regulatory compliance process - improving conformance to regulations & standards, yet at the same time reducing the cost of compliance activities.
The Dyadem Solution
Dyadem provides comprehensive Quality Risk Management (QRM) solutions that enable global Biotech and Pharmaceutical companies to reduce risk management efforts by 50%-80%. In addition to improved quality, compliance risks are reduced to avoid non-conformances. Dyadem provides the essential elements of the ICH Q10 Pharmaceutical Quality System:
  1. A Lifecycle approach to all risk management related documents - linking documents such as Development Requirements, Preliminary Hazards Analysis (PrHA), Design FMEA, Process FMEA, Control Plans, etc. through retirement of the product.
  2. Real-time visibility into quality & risk information, which enables Management to participate in the quality system and ensures timely communication and governance of risk.
  3. Corrective and preventive action workflows with various root cause analysis techniques, such as 8D or 5Y. Stature can also integrate to existing CAPA systems.
  4. Supports ICH Q9 Quality Risk Management processes and methodologies.
  5. Knowledge management capabilities to facilitate continuous improvement. The centralization of all risk assessments and related documents in a single database, allows historical knowledge to be dynamically searched and reported on. Knowledge libraries capture lessons learned for pro-active use in risk assessments, reducing effort and improving consistency. These capabilities avoid the risk of repeat failures across products or sites.
Dyadem also provides Operational Risk Management solutions to ensure the safety of people and the environment and avoid costly shutdowns and interruption to the business.

Stature for Operational Risk Management
Stature for Quality Risk Management
PHA-Pro
FMEA-Med
FTA-Pro
"In our industry, quality and risk management parameters are integrated into all aspects of research, development, production and application, as our products must perform flawlessly. Dyadem's software allows us to work in a more uniform environment, and assess quality in a standard way."

Genzyme Corporation