8 Essential CSV Documents You Need for FDA Auditors [Video]
Testing is done, the software is released. What could go wrong? Audits and auditors!...
4 Questions You Need to Ask to Ensure a Deviation is NOT Repeated [Video]
The aim of deviation closure is to certify that the deviation won’t be repeated...
The Life Cycle of a Deviation Explained with Industry Example [Video]
A deviation was reported by a microbiologist in the quality control department indicating a...
5 Tips to Help You Write Better Deviation Descriptions [Video]
When issuing the deviation, details of the deviation such as Name of the Deviation...
Screenshot Management When Executing Software Validation Protocols [Video]
For each test performed, clear and unambiguous acceptance criteria needs to be defined. This...
Top Tips When Retesting Software in a Regulated Environment [Video]
Risk assessment gives you a good idea what to re-test. But what is sufficient?...
8 Actions You Need to Take To Successfully Close Out a CAPA [Video]
If nonconformities are determined to be systemic (i.e., the nonconformity has been realized AND...
8 Process Requirements the FDA Want in Your CAPA System [Video]
Corrective and preventive action also called CAPA are improvements to an organization’s processes taken...
Your 2 Minute Guide to Software Validation Deviations [Video]
Deviations are when an actual result differs from an expected result; these are often...
10 Sections Your Software Validation Master Plan (VMP) Must Include [Video]
When building a house, the first thing you must do is create a blueprint....