Azzur Articles

3 Important Steps to Power Failure Temperature Mapping

When the power goes out, the clock starts ticking for cooling units that lack a back up generator. Power Failure studies are important to providing documented evidence that a cooler or freezer unit will recover, with all set points in tack, after power is removed from the unit for a set amount of time. 

In this final article in a series on Temperature Mapping Studies, Azzur's Abby Rutman addresses three important steps to accurately performing a Power Failure Temperature Mapping Study. 

When the power goes out, how long do you have before risking loss of product?


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3 Important Steps to Open Door Temperature Mapping

Open Door Temperature Mapping studies are important to providing documented evidence, with a high degree of assurance, that a cooler or freezer unit will recover when the door is open for a set amount of time. 

In a follow up to an article on Temperature Mapping, Abby Rutman addresses three important steps to accurately performing an Open Door Temperature Mapping Study. Find out if you’re asking the right questions – or providing the right answers.


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USP General Chapter <797> Revisions: Where Are We Now?

On September 25, 2015, the United State Pharmacopeial (USP) General Chapter <797> Pharmaceutical Compounding – Sterile Preparations was posted to the Pharmacopeial Forum (PF) with notice for the intent to revise. The revision of this general chapter had been eagerly awaited by all those involved, both directly and indirectly, with compounded sterile preparations (CSPs). But before this revision could go into effect, it needed to be circulated for public review and comment. The chapter remained out for public comment until January 31, 2016.

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3 Important Steps to Temperature Mapping

Prior to performing a qualification or requalification on any controlled temperature unit, ensure you have all documentation required to meet the manufacturer and site requirements. It’s recommended to physically see the unit prior to starting any documentation to ensure that all the supplies/materials are all accounted for in order to meet the site requirements. 

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9 Steps to Overcoming Data Integrity Challenges in the Laboratory

Being a Laboratory Manager in a regulated environment (FDA, CLIA, CAP etc.) can be stressful for a number of reasons not the least of which is the increasing scrutiny by regulators around data integrity.  While we can all agree that data integrity is of significant importance in the laboratory setting, the process by which this is achieved and maintained continues to be the subject of much debate.  Without a doubt this mission is daunting in the face of demanding daily operations and evolving interpretation of regulations.
 


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VFD Disaster Recovery

Even with regular maintenance, sometimes equipment breaks. You may not always be able to prevent this failure, but you can significantly reduce your downtime by taking just a few steps.
Find out how Azzur helped one company recover from equipment failure and what you can do to avoid your own costly disaster.


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Compliance in the Cloud or the high road to GxP?

"To the Cloud or not to the Cloud, that is the question."  While it’s certainly a familiar question, with apologies to Hamlet, there is a question that tends to come first: “What is the Cloud in the first place?”  Have you seen this online graphic lately of a young child who is just looking at you with the caption – "There is no cloud…" 

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Building a Soil Library

A soil library can be an extremely useful tool to help determine worst-case soils in a facility. It can provide valuable data for establishing processes, determine cycle requirements for cleaning or it can be used to support cleaning compliance.

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Information Security: Why Life Sciences is Lagging Behind Other Industries

Integrating an information security framework is a crucial step in preventing security gaps which unresolved, could potentially lead to network data breaches. Different types of controls can be implemented within a system to improve confidentiality, integrity, and availability of critical data.

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The Portfolio Effect of Supplier Development

Supply chain management is a critical function for any business big or small. Supply Chain Digest notes that the average manufacturing firm spends over 50 percent of its revenue on purchased inputs. Given businesses reliance on third-party supply chain "partners," it is no surprise that the supply chain profession has gained prominence and visibility in the C-Suite in the new era of globalization.
June 18, 2015
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Network Security Gaps And Its Impact On Your Data

Data integrity is a fundamental corner stone of the pharmaceutical industry that ensures the quality of the manufactured product. However, common security strategies implemented at facilities do not provide the necessary protection against electronic data alteration. Whether to protect from malicious manipulation of software or accidental deletion of program and data, a multi-layered strategy is necessary to achieve a level of confidence in the integrity of the data and process.
May 27, 2015
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The War for Talent: Reality or Myth?

Download our guide to find out why you could be chasing away top talent. 
June 18, 2015
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