Executive Editorial

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.

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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 are 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.

Tim Kehling Pedersen CEO, QAtor A/S

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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