Notes 2 Fix Your Notes 2 File

Q: If Notes to File can be regulatory red flags, should we quit using them?
A: No, and here's why...

Regulatory inspections are often conducted long after the conclusion of the study. When an FDA investigator asks you a question about an anomaly five years after it’s happened, will anyone recall the circumstances well enough to satisfy the regulator’s concerns? You’ll be doing yourself a huge favor if you write NTFs that answer the questions regulators might one day be asking you.

The CAPA Detective

By Laurie Meehan

Every industry has its detectives.  Mechanics and journalists hunt for leaks.  Software testers and security experts look for bugs.  Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore.  The level of intrigue may vary.

In the GMP world, it’s the CAPA investigator who serves as detective, identifying how and why manufacturing defects occur.  The root cause is seldom obvious or sensational, but usually a confluence of seemingly innocuous deviations that can compromise an otherwise high-quality manufacturing process.  That’s not terribly flashy, so you probably won’t find “The CAPA Detective” in among the other crime dramas making their debut in this year’s primetime lineup.

Or maybe you will.

On the Quality of Vendor/Supplier Audit Responses

The Compliance Perspectives post this month was written by guest blogger, John Janeri, an independent contractor working with Polaris.

After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.  I’ve done many of these solo audits, and I’ll admit that I've often wondered who at the Sponsor* company would communicate the findings to the Auditee and review their responses.  But no matter, I've completed the contracted assignment and I'm now off doing something else, right?  Not so much anymore.