Preparing for an ISO Audit Mark Durivage
Preparing for an ISO Audit

Preparing for an ISO certification, surveillance, or recertification audit can be daunting stress filled task, [...]

Risk process for determining the appropriate AQL
c=0 Sampling Plan Table

How To Establish Sample Sizes For Process Validation Using C=0 Sampling Plans By Mark Durivage, [...]

Understanding DOE’s Foundational Elements

Design Of Experiments 101: Understanding DOE’s Foundational Elements By Mark Durivage, Quality Systems Compliance LLC [...]

Is Your Personnel Hygiene Plan Up To Date
Is Your Personnel Hygiene Plan Up To Date?

By Mark Durivage, Quality Systems Compliance LLC Every organization that is regulated by the FDA [...]

certificate of Quality Systems Complaince Top 10 Medical Device Consulting Company 2019
Ranked on Top 10 List Medical Device Consulting Companies in 2019

Quality Systems Compliance named one of the Top Ten Medical Device Consulting Companies in 2019 [...]

How To Prepare For An FDA Inspection
How To Prepare For An FDA Inspection

How To Prepare For An FDA Inspection By Mark Durivage, Quality Systems Compliance LLC Every [...]

A Military Tool For Pharma Vulnerability Assessment
A Military Tool For Pharma Vulnerability Assessment — The CARVER + Shock Technique

By Mark Durivage, Quality Systems Compliance LLC Following the terror attacks of Sept. 11, 2001, [...]

FDA Proposes Program To Establish Voluntary Pharma Quality Standards
FDA Proposes Program To Establish Voluntary Pharma Quality Standards

By Mark Durivage, Quality Systems Compliance LLC The FDA’s Center for Drug Evaluation and Research [...]

What Should You Do After An FDA Inspection Article by Mark Allen Durivage
What Should You Do After An FDA Inspection?

What Should You Do After An FDA Inspection? By Mark Durivage, Quality Systems Compliance LLC [...]

ALCOA Principles

Quality Systems Compliance L.L.C. Your compliance partner… ALCOA Principles: Data Integrity for the FDA Regulated [...]