by pathwise123 | Jun 12, 2024 | FDA, Investigations/CAPA, Uncategorized
What’s the Right Number of CAPAs? Spoiler alert- it’s not an exact number, and that number isn’t zero. The right number of CAPAs will vary organization to organization based on several factors, which we will outline for you below to take into consideration when...
by LindaMarie Beitler | Feb 16, 2022 | FDA
Top 483 Observations in 2021 Every year, PathWise complies the top FDA 483 observations from their inspection observations to view trends and patterns. In a year with fewer inspections due to pandemic disruptions, there were still notable trends. Download our data,...
by pathwise123 | Mar 10, 2021 | FDA, GCP
SIX CONSIDERATIONS FOR GOOD CLINICAL PRACTICES Clinical trials help us answer critical questions about treatments, therapies and medications: Does the therapy work? Does the medication work better or equal to already existing medications? Does the therapy cause side...
by PathWise | Feb 10, 2021 | FDA, Uncategorized, White Papers
Inadequate Procedures: A Challenge to the Medical Industry As global populations increase and people are living longer, more strain is being placed on the life science industry. Complex business models have evolved, and new technologies are implemented to support...
by PathWise | Aug 31, 2020 | FDA, Investigations/CAPA, White Papers
When Root Cause Eludes You In the investigation system that helps us ensure our products are complaint, there is one moment every investigator dreads…. when root cause is not able to be clearly identified. Root cause identification is our goal and it is not achievable...
