Category Archives: Data Integrity

Data Transfer / Migration: Data is one of the most important assets that a company owns. Data is collected and analyzed to create information for decision making. Data influences patient safety or product quality in Life Sciences Data migration performed for many reasons: like mergers & acquisitions (many sources to many targets), new business modelsContinue reading “Data Transfer / Migration & Its Strategies”

Data Integrity: “The extent to which all data are complete, consistent and accurate throughout the data lifecycle all its forms, i.e. paper and electronic.” Data integrity arrangements must ensure that the accuracy, completeness, content and meaning of data is retained throughout the data lifecycle. It can describe the state of data E.g. data valid orContinue reading “What is Data Integrity & Its Principles”

Introduction of Mock Inspection MHRA has said, “QA should also review a sample of relevant audit trails, raw data and metadata as part of self- inspection to ensure ongoing compliance with the data governance policy/procedures.” According to PIC/S, “The effectiveness of data integrity control measures should be assessed periodically as part of self-inspection (internal audit) orContinue reading “Importance of Mock Inspection & its Benefits”

In simplest terms, if your data can’t be trusted, neither can you. The integrity of the data collected and recorded by pharmaceutical manufacturers is critical to ensuring that high quality and safe medicines are produced. Data integrity issues impact the entire company, bringing into the question the capability of those tasked with assuring quality andContinue reading “Root Causes of Data Integrity Issues”

What is Data? “Facts, figures and statistics collected together for reference or analysis. “ All original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, that are generated or recorded at the time of the GXP activity and allow full and complete reconstructionContinue reading “What is Data in Pharmaceutical Industry?”

History of CSV: History:                The concept of validation was derived from engineering principles of validation of           mechanical system that has been extended to the software industry. To extend it further during mid-1970’s, Ted Byers and Bud Loftus, two Food and Drug Administration (FDA) officials first proposed the concept of validation in order to improveContinue reading “History of Computer System Validation in Pharmaceutical Industry”