One Q & a Lotta A’s about SOPs for Research Sites

SOPs or work instructions--- which does a clinical research site need? by Laurie Meehan Social Media Manager Polaris Compliance Consultants,...

Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

Can't find the right lid for the barrel?  You might find  a different lid that almost fits and use duct tape. But if  you do,  chances a...

The CAPA Detective

In the GMP world, the CAPA investigator  is the detective, identifying how and  why manufacturing defects occur. by Laurie Meehan Social Med...

Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

Preparing for an inspection will help ensure a smoother,  less stressful experience. A mock inspection is a useful practice tool. by Kelly T...

4 Reasons Why Document Review is Crucial to Compliance

When was the last time you reviewed  your quality documents? by Cindy Fazzi Editor, MasterControl Insider When was the last time you reviewe...

How to Tip Off a GCP Auditor in 25 Words or Less

"Jane, quick!  The auditor's here!  What's an SOP?" by Laurie Meehan Social Media Manager Polaris Compliance Consultants “...

Four Reasons to Automate SOP Management in FDA and ISO Environments

In FDA and ISO environments,there are multiple  reasons to consider automating SOP management. by David R. Butcher,  Marketing Communication...

Five Steps to Building Process Efficiency with Your Supplier

As supplier activities become more complicated,  there's a new role for a supply chain liaison consultant  who can facilitate activities...