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White Paper

Assuring the Molecule’s Journey - Conception to Cure and Beyond

 

In order to survive and compete in the stringently regulated world of pharmaceutical manufacturing, companies need a robust assurance framework that can address compliance and quality requirements successfully. Assurance is an umbrella for all compliance requirements of the various stages of a product lifecycle in the life sciences industry.

Considering the impact drugs have on health, and human life itself, strong regulatory control is essential to ensure the efficacy and safety of medicines. In this highly regulated environment of the life sciences industry, if compliance, safety, efficacy, and quality form the key pillars of complex drug development, assurance is the foundation they rest on.

To ensure compliance and quality, assurance needs to be threaded into all key activities such as the functionality testing of systems to ensure that they meet user requirements, audits to verify that systems are compliant, audit programs to test the design of a system and its effectiveness, and SOPs to ensure the correct use of systems. Since regulatory obligations differ from country to country, the assurance provided by compliance needs to be tailored to each of these localized requirements.

Recognizing the crucial role of assurance, pharmaceutical companies are leveraging a robust assurance framework to thread compliance into every stage of the product lifecycle.

In this white paper, we discuss the various approaches and facets of assurance that are critical to drug development.

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