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The process of successfully launching a new drug involves many scientific and medical professionals with the total cost of each successful product launch being a 10th of millions dollar high risk project. Additionally, when all project related procedures and protocols are simple electronic files or even paper-based documents the risk of inaccuracies and non-compliance long feedback loops and delays are virtually ensured.
Unless Life Science companies consider changing existing working practices, they will find it increasingly difficult to comply with federal regulations AND at the same time achieve the double-digit earnings that have become expected of our industry. In addition, as industry competition is constantly increasing and product life cycles becoming still shorter, corporate performance challenges are ever more severe.
Commonly acknowledged issues with paper-based procedures are:
- Lack of compliance, consistency, and accountability in the process
- High resource need for control of quality assurance, & GMP process itself
- Suspicious audit trail
- Low re-use of knowledge across the enterprise
- No electronic signatures – No electronic submissions
All issues resulting in unnecessary slow compliance process with very high costs associated.
To develop capabilities that follow constant rapid growth, Life Science companies need to deploy compliance management technologies as a way to dramatically streamline the research and development (R&D) compliance processes thus improving productivity and decreasing the time to market.
No competitive advantage is as powerful as being first to market in any sense. Streamlining compliance management for drug discovery, clinical trials, submissions, or/and regulatory approval processes while simultaneously containing costs, maximizing quality assurance efficiencies, and ensuring compliant information management is critical to long-term survival.
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Tim Kehling Pedersen
CEO, QAtor A/S |
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