Audit Management Posts

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Recently, we hosted two live demonstrations of SmartSolve Audit Management. The webinar covered a number of topics including how to perform mobile audits, creating audit programs and schedules, working on audits, and managing audit followup.  The webinar also included live Q&A during both sessions.

Some key themes emerged during both sessions that helped us understand the challenges you may encounter when carrying out quality audits, and how SmartSolve Audit Management can help.

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The Anatomy of Great Risk-Based GMP Audits

The Anatomy of Great Risk-Based GMP Audits

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

If you’re responsible for planning and carrying out your company’s internal audits, you know how much planning and effort it takes to monitor your quality system for GMP and ISO compliance. As your quality system has matured, you’ve probably noticed that certain sites, departments, or processes require more of your attention, while others are consistently in compliance and don’t need as much assistance. If this is the case in your organization, it’s time for you to consider a risk-based approach to your internal quality system audits. (more…)

Medical Device Single-Audit Pilot: Will it Fly?

Medical Device Single-Audit Pilot: Will it Fly?

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

We’ve all seen them. Some flop, some fly. Television Pilots — stand-alone episodes of television series used to sell shows to the networks by gauging whether a series will be successful. After seeing this sample of the proposed program, networks then determine whether the expense of additional episodes is justified.

There’s another type of pilot airing right now in the Medical Device industry, and the purpose is similar. (more…)

Unannounced Regulatory Audits Hitting Global Med Device Community

Unannounced Regulatory Audits Hitting Global Med Device Community

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

No one likes to be caught off-guard. Have you ever had a contractor show up at your home before you’ve even woken up? Or your child tells you he needs his original birth certificate the very next morning to register for camp. These facts of life often arise when you least expect it. (more…)