Special Reports
November / December 2017

Special Report: Data Integrity & Biopharmaceutical Manufacturing

Nissan Cohen
Data Integrity & Biopharmaceutical Manufacturing - ISPE Pharmaceutical Engineering

Before the advent of integrated computer systems, LIMs, HMI interfaces, comprehensive software, CGMP, BAS, process control systems, PAT, and the use of statistics, manual record keeping was fraught with errors—most of them unintentional. This led to citations for missing data, signatures, and date and time entries, to say nothing of the risks posed to patient safety.

Since the Sarbanes-Oxley Act was passed by the US Congress in 2002, a greater emphasis has been placed on data integrity in biopharmaceutical manufacturing. Changes in 21 CFR part 11, ICH mandates, and European and US pharmacopoeias have also influenced the need to maintain data in formats that are both sacrosanct and inviolate.

Today, the need for data integrity is foremost in our documentation, analytical records, measurements, and requirements. Data integrity demonstrates that processes operate within proscribed limits, and ensures that we can archive, retrieve, and show the data for any state of the process at any given moment in time.

This Special Report provides insights into how we manage, use, and incorporate data to protect the integrity of all values, measurements, and processes—as well as comply with regulatory mandates and guidances.

Lessons Learned from the Sarbanes-Oxley Act

Fifteen years ago, corporations embarked on a journey toward SOX compliance; along the way they have learned a tremendous amount about data integrity as it relates to financial systems. Those lessons learned are directly applicable to many of the data-integrity challenges facing the pharmaceutical industry today.

Considerations for Database Privileged Access

Individuals with privileged access have the technical means to bypass the user interface to access and modify data, oftentimes without traceability

Prepare for Regulatory Audits with Your Supplier

Data integrity continues to be a very hot topic for both regulators and the pharmaceutical industry. With the increased observations about data integrity in laboratories, could it be that analysts have changed how they do science in the laboratory? Are analysts working differently today? Have they suddenly started disregarding the importance of the data they generate? Can regulators no longer trust laboratory results?

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