Trends in FDA Data Integrity 483s and Warning Letters for Pharmaceutical Companies
The manufacture of pharmaceutical drugs is a highly complex process that involves advanced scientific analysis and instrumentation at all stages of production and storage. In order to guarantee the safety and efficacy of both human and veterinary drugs, the FDA strives to verify data integrity in all cGMP records used to document and guide the […]
Tips for Maintaining Laboratory Data Security
On June 27th, 2017, a massive ransomware attack infiltrated computer systems and locked up files (via encryption) at companies around the world and government ministries in Ukraine. Merck & Co. was among those affected. Merck employees arrived in their offices in the morning to find a ransomware note on their computers with hackers demanding payment […]