The US FDA (Food and Drug Administration) is known for many things. However, adaptability and the willingness to harmonize with other regulatory agencies worldwide might not be one of them. Nevertheless, in 2018 the FDA began work to reconcile the US...
Top 11 FAQs about GMP Guidelines for Quality Management Systems The GMP guidelines are mandatory in most countries for pharmaceuticals, medical devices, and food industries. Companies that fail to comply with these guidelines can face severe regulato...
In GxP-regulated sectors like pharma, biotech, and medtech, computerized systems play a key role in ensuring patient safety, data traceability, regulatory compliance, and integrity. Many regulations and guidelines have been developed to validate such...
What Are ATMPs? ATMPs is an acronym for Advanced Therapy Medicinal Products. These medicinal products are based on genes, tissues, or cells. Research shows that ATMPs provide promising therapeutic applications for Alzheimer's disease, cancer, muscula...
As the life sciences are digitalizing at an unprecedented scale and rate, data lifecycle management is becoming more important than ever.
Internal audits can strengthen the quality management system (QMS) of your organization by improving sub-processes by identifying open issues and opportunities. In addition, internal audits can be more informal than external audits so that your organ...
We all know at least one John, who was a great fit for the job posting published by the organization last week, but the talent manager never knew about John. The talent manager failed to recognize the talent within the organization and hired a new em...
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