Data Archives

Principles of Data Integrity

Data integrity is one of the most critical factors in any regulated industry. This is because any data error could...

‌ Every organization that manufactures medical devices, pharmaceuticals, biologics, cosmetics, or other types of...

‌ Navigating ever-changing markets and supply chains has been challenging for many companies in the ongoing...

‌ For a long time, healthcare was in the hands of doctors. People listened only to their doctor’s advice on how...

‌ In highly regulated industries, document control is among the most necessary means for compliance. A document...

‌ Regulations ensure medical device manufacturers produce consistent safe products. A well-structured...

‌ With Halloween behind us, the most wonderful time of year is almost here, flu season! The COVID pandemic set a...

‌ As the digital age continues to advance at an amazing pace, healthcare and medical devices have managed to...

‌ It is no secret that AI/ML medical devices are under a special spotlight by international regulators this...

‌ So many parents, who have been on a continuum of anxiousness since the beginning of the pandemic, were finally...

‌ Registering a cosmetic product with the FDA is simple, so simple it is not even required by the FDA. The...

‌ Good Manufacturing Practices, or GMP’s, are well known for people in the medical device and pharmaceutical...