Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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Data integrity problems on the rise. Defined by the FDA as the “completeness, consistency, and accuracy of data … data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate,” data integrity processes require that there are mechanisms in place to prevent accidental and/or intentional unauthorized modification of the data.
Incorrect or false data related to product identity, quality, purity or potency has serious implications, which include patient injury, drug shortages, damage to corporate reputation, lost profits and both civil and criminal liability. More challenging to quantify is the impact of lost credibility with customers, employees and regulatory bodies.
Understanding individual quality systems is essential in evaluating the overall corporate approach to quality. The true test of a quality management system is how it works when things go wrong. A risk-based approach is appropriate for uncovering data integrity issues and the approach should be based on the perceived urgency, leadership’s commitment to quality and the role and remit of the individual making the assessment.
IQVIA takes a structured approach for characterizing and optimizing quality systems, there are five leading solutions for re-mediating and preventing data integrity problems:
Contact us and let’s put our compliance technology and expertise to work for you.
Promote continuous improvement
Robust compliance programs to reduce your current and future exposure
Drive compliance and accountability with your sampling program.
Responding to FDA enforcement.
Fulfilling your compliance obligations and safeguarding your organization.
Keeping your organization safe without compromising patient care.
Take the work and risk out of compliance.
Reduce your administrative burden with our state licensing services.
Easing the path to compliance and reporting with technology.
