The consequences of FDA citations can be costly. In this blog article, we discuss the top two FDA citations for pharmaceuticals and how to avoid or prevent them. In the United States of America, pharmaceutical drugs and medical devices are controlled according to The...
News & Blog
Quality Risk Management for Commissioning and Qualification
Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV) in pharmaceutical and medical device industries define a detailed and science-based process for the specification,...
Inspections and Audits: What You Need to Know
Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and learn about inspection and audit best practices in our series of blogs on inspection management. The Importance of First Impressions on Inspection Day Did...
Cybersecurity | Keeping your data safe with eQMS
Across the world, Russian ransomware attacks increased in 2021. Ransomware incidents in the US increased 82% from 2019 to 2021, and the US government is closing ranks with energy firms to guard against attacks. How does this affect pharmaceutical and medical device...
The Pitfalls of Data Migration
Did you know that the FDA regulates data integrity? Pharmaceutical and Medical Device industries must operate in accordance with current Good Manufacturing Practices (cGMP) for regulatory industries, such as the FDA and MHRA, to deem a product as safe for consumers....
Get Your Cleanroom Ready for Business
When you think of a pharmaceutical or medical device company, cleanliness comes to mind when production comes to mind. Cleanrooms are a necessity when it comes to a company's production area. What is a cleanroom exactly? A cleanroom is a controlled environment used in...
Record Keeping and Documentation for GMP compliance
A company's records are a prized possession and should be taken care of the best way possible. When we think of good manufacturing practices (GMP), regulations must be followed to keep the quality and integrity of your records in good standing. Current GMP...
Paperless Validation – What is it and why you need it
Pharmaceutical and biotechnology companies need to assure product quality using validated equipment and computer systems. Computer Systems Validation (CSV) is the process of ensuring that equipment, software, spreadsheets, utilities, and other computerized processes...
It’s a GMP Kind of Thing
Is your company compliant with GMP? Or is your company transitioning to GMP compliance? If you’re asking yourself, "what is GMP?" it stands for Good Manufacturing Practices, a system used in the production of food, pharmaceutical, and cosmetics industries. The system...
Mastering Stress in the Great Resignation of 2022
In our last blog article on Re-Thinking the Great Resignation of 2022, we highlighted the impact of transformative experiences on decision-making and problem-solving. Another significant element during the COVID-19 pandemic era is the chronic presence of stress and...