Summary:
Every business faces risk. Broadly speaking, the primary categories of business risk are Market, Financial, Execution, and Regulatory. Successful companies have developed a core competency in managing for these risks, turning risk management into a sustainable competitive advantage. For drug manufacturers, recent trends have underscored the importance of managing Regulatory risk in order to remain a viable business. More specifically, these trends have raised the profile of Data Integrity (“DI”).
Overview:
This white paper highlights the cost of reactive regulatory compliance is daunting, and erodes credibility with customers, employees, reduces time to market and limits future strategic options. It also elucidates the risks of non?compliance increase with the number of NDAs/ANDAs and facilities, as increased scrutiny comes with scale, and regulatory authorities are willing to send warnings to multiple sites based on the review of one site. This study serves as a pharmaceutical manufacturer’s number one lever to pull to reduce risk of regulatory action is in improving Data Integrity. Doing so may provide a sustainable advantage in a highly competitive market.
This white paper also lists recommended practices to improve data integrity in a healthcare facility like—proactive working with outside specialists to educate company and site leadership, along with all site personnel, on their responsibilities and the need for absolute personal accountability in ensuring integrity of practices, data, records, and documentation, making sure you have sufficient knowledgeable GMP/QA and supervisory personnel. One manager overseeing 200 scientists just won’t do. This white paper also recommends the creation and enforcement of a company-wide standard for data integrity and the ethical behaviour required to follow such standards, and provide expert training to affect these standards. Lastly, continuously and rigorously auditing actual performance against integrity standards for the systems, procedures, controls, and documentation practices that assure the reliability of data, records, and their documentation, is highly recommended.
