Resources

Before anyone can manage a great quality system, they need to make sure it is developed the correct way. Developing a QMS is the foundation for ensuring the organization’s products...

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding 21 CFR Part 11 and electronic batch records. Q. What is a master...

Preparing a Clinical Evaluation for a CE Mark is no small task. Having it rejected by reviewers, and doing it over again to correct deficiencies is not uncommon. Clinical evaluations...

Q: I am familiar with the term ALCOA as it relates to data integrity, but lately, I have heard people refer to ALCOA+. Can you explain what impact this new...

It is no surprise that over the course of 2021 with the COVID-19 pandemic that businesses have adjusted their model to accommodate FDA audit remote work. Whether that be associates...

Medical Devices When a medical product fails in the field, everyone suffers — not just the patient, but also the manufacturer and its employees, investors, suppliers, and even competitors. No...