Maintaining Data Integrity remains one of the greatest challenges for the life science industry. In the last 4 years from 2014-17 there has been over 5-fold increase in as warning letters related to data integrity.
If you are a Business Process Owner, IT Systems/Business Applications Owner, QA/QC or any play any role where data is the basis of your decision making then it is critical for you to understand the fundamentals of data integrity and how it impacts your business if your data is inaccurate and inconsistent. You need a strategy to leverage your people, processes, procedures and technology to maintain the integrity of your most valuable asset “Data”
Regulatory emphasis on Data Integrity: Data is the backbone of cGMP compliance because the impact of having contaminated data could lead to warning letters, forced recalls or shut downs. This will not only lead to loss in revenue, but also significantly impact the product quality and patient safety leading to tainted brand reputation forever.
In the recent past, regulatory agencies globally have stepped up their focus on data integrity because they have observed CGMP violations involving data integrity during inspections.
Data Integrity by Design: Self-Monitoring & Governance
While compliance with regulatory requirement is mandatory, consistently producing safe and effective drugs that demonstrates value to the payor can be accomplished by ensuring data integrity by design. It involves, risk assessment, standardizing data management and governance processes and procedures, fostering culture of continuous learning and leveraging systems and innovative technology.
Data is the fuel for Transformation of the Biopharmaceutical Industry: Transformation of the bio-pharmaceutical industry depends on how well it can execute its digitization strategy which eventually depends how well it can harness its most valuable asset “data”. Therefore, integrity of data can never be overstated.
Some key areas of discussion.
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