Newsletter | August 29, 2019

08.29.19 -- Organizational Design's Relationship With Data Integrity

Featured Editorial
What Organizational Design Says About Your Commitment To Data Integrity
By Kip Wolf, Tunnell Consulting

Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.

Industry Insights
Transcutaneous Electrical Nerve Stimulation (TENS): An Overview Of Its Expanding Role In Pain Management
White Paper | Cardinal Health, Inc.

The gate theory of pain states that, before reaching the brain, pain messages pass through a series of nerve “gates” in the spinal cord. This white paper discusses TENS technology, how it works, and the advantages this treatment has over alternative pain management techniques.

Can The Medical Device Industry Overcome Legacy Sterilization Methods?
Article | REVOX Sterilization Solutions

As companies continue to innovate, they are finding that some of today’s most commonly used sterilization methods impose serious limitations in terms of efficacy, quality, or production processes.

Reducing The Life Cycle Cost Of Validation (Part 2): Mold Design, Construction, And Protocols
Article | By Kyle Kulwicki, PTI Engineered Plastics, Inc.

In Part Two of this series, we look at best practices for mold design, mold construction, and development of protocols, as these steps of the process also play a vital role in the long-term costs of validation.

The Benefits Of Aqueous Critical Cleaning In Pharmaceutical Manufacturing
Article | By Malcolm McLaughlin and Jeff Phillips, Alconox, Inc.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact, reduced residue potential, and easier cleaning validation.

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