Pharmaceuticals & Biotech
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 the European Medicines Agency and standards such as ICH, GMP and ISO 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.
| Challenge | Solution |
| Streamline the regulatory compliance process, for ICH Q10, and simultaneously reduce cost | Integrate Risk Management Processes – Stature provides 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. It also helps organizations comply with ICH Q9 and Q10 processes and methodologies. |
| Repeat failures or product recalls | Gain Risk Visibility – Real-time visibility into quality & risk information, enabling Management to participate in the quality system and ensures timely communication and governance of risk. |
| Limited transparency into risk management practices by senior leaders | Act decisively – Effective operational quality management with Stature allows senior leadership, stakeholders and program management to make better decisions with more accurate information. |
| Inconsistent quality risk reporting leading to faulty post-market feedback, product failures and increased risk to patient safety | Retain Knowledge – Stature allows you to centrally edit, store and share years of best practices for mitigating risk and lessons learned along the way. This helps to avoid the risk of repeat failures across products or sites. |
| Disparate systems for risk management and varied forms/styles of documentation | Integrate Workflows – Stature includes integrated workflows and a lifecycle approach to all risk management related documents - linking documents such as Voice-of-the-Customer (VoC), Design Input, Validation & Verification, Preliminary Hazards Analysis (PrHA), Design FMEA, Process FMEA, Control Plans, etc., allowing for full disclosure and accurate impact analysis, as well as better future design decisions. |
| Inconsistent quality culture and weak or unenforced policies for managing quality risk | Drive Quality Risk Culture – Using Stature you can develop a consistent framework for quality management across your operations and embed quality risk management and governance into your culture. |
| Lack of a consistent, standard format for quality risk identification, analysis and mitigation | Reduce silos – A common quality framework across your enterprise ensures that everyone is speaking the same quality language, helps develop a unified quality culture and ensures that you are always aware of the risks that could impact patient safety and your business. |
| Long reporting cycles that render information out-of-date and limit immediate action | Automate Key Quality Processes – Stature takes mission-critical business processes and makes them actionable. By automating the business process, leadership can be confident that key quality risks are being actively managed, monitored and mitigated. Integrated escalation, notification and scenario-based lifecycles ensure all aspects of the process are covered. |
| Reduced budgets and resources to effectively manage quality risks | Maximize Resources – Stature ensures that your quality management and audit teams are spending less time gathering information and more time lowering risks. |
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