This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and ...
The COVID-19 public health emergency has prompted regulators to take a different approach to uncovering data integrity violations in virtual inspections compared to onsite inspections, said an ...
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Why lab integrity matters more than ever
From drug safety testing to AI-enabled medical devices, ethical and regulatory standards are the backbone of trustworthy science. Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and ...
Built-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight the ...
Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, manual data transcription and all too frequently ...
Increased regulatory focus on data integrity violations in GxP inspections opens opportunities for pharma companies to invest in staff training and compliance strategies related to document management ...
Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such ...
The filter integrity test market benefits from rising demand in food & beverage and biopharmaceutical sectors driven by ...
Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further ...
Data integrity is a hot topic for regulators and auditors, making it important to understand data integrity criteria for the laboratory – and apply the principles correctly. A free on-demand webinar ...
European Commission revisions to Chapter 4 align documentation expectations for electronic records and signatures with an updated Annex 11 focus on data integrity controls. Annex 11 enhancements ...
Throughput, efficiency, and reproducibility are key concerns in laboratory studies. Advances in digital science solutions and automated technologies are driving recent improvements in lab results, ...
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