Robert Marohn, ClinLogic, LLC09.06.17
In the recent JulyAugust issue, Contract Pharma looked at the issuance of data integrity guidance documents by four of the world’s leading regulatory agencies. Taken together, these guidelines stipulate an array of data integrity and governance expectations.
All four of the regulatory agencies’ directions on data integrity make the point that it is important for an organization to consider the sum total of measures that ensure data integrity, irrespective of the process, format or technology in which data is generated, recorded, processed, retained, retrieved and used throughout the data life cycle, and that these preparations guarantee complete, consistent and accurate records.
This article looks at some of the ways an organization can establish a culture and cost-effective means to meet the various challenges in sustaining data integrity. Particular emphasis is placed on a practical and risk-based approach toward data integrity governance. Sensibly, data integrity governance can be accomplished through: marshalling the proper expertise and thoughtful planning, training and leveraging cGxP knowledge, assessment and risk anal
All four of the regulatory agencies’ directions on data integrity make the point that it is important for an organization to consider the sum total of measures that ensure data integrity, irrespective of the process, format or technology in which data is generated, recorded, processed, retained, retrieved and used throughout the data life cycle, and that these preparations guarantee complete, consistent and accurate records.
This article looks at some of the ways an organization can establish a culture and cost-effective means to meet the various challenges in sustaining data integrity. Particular emphasis is placed on a practical and risk-based approach toward data integrity governance. Sensibly, data integrity governance can be accomplished through: marshalling the proper expertise and thoughtful planning, training and leveraging cGxP knowledge, assessment and risk anal
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