compliance - Blogging About What's Possible

Recent posts

Attribute Monitoring Workflows [Infographic]

By November 18, 2021

Learn how the BioAccord LC-MS System is instrumental in the drug development workflow from sample prep to reporting.

Categories: Pharmaceutical
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BioAccord System with ACQUITY Premier: Some Things Work Better Together

By September 13, 2021

Combining BioAccord, our most capable MS detection platform, with ACQUITY Premier UPLC, our highest performance LC system, to demonstrate superior performance.

Categories: Pharmaceutical
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Embracing Analytical Techniques Into Regulated Laboratories

By March 2, 2021
biopharma compliance

To ensure compliance success in a changing regulatory landscape, laboratories must continually adapt. Learn how the compliant-ready Waters BioAccord LC-MS platform helps biopharma address the additional compliance challenges posed by the field’s complex analytical instruments.

Categories: Pharmaceutical, Technologies
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Traceability in OneLab: OneLab configuration by the Lab Administrator

By August 14, 2020

Bringing increased confidence to sample preparation workflows using automation, smart laboratory tools and electronic documentation for recording analyst activities Consistency, accuracy, compliance and data integrity can each be improved with automation of laboratory processes. We… Read more >

Categories: Regulatory Center
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Data Integrity Matters | The Human Factors

By August 25, 2017

3 signs that you need to create a culture of compliance As mentioned in my first post on data integrity, people trust that companies create safe, quality products and rely on data to support that… Read more >

Categories: Regulatory Center
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Data Integrity Matters | Why is Data Integrity a Hot Topic Now?

By June 30, 2017

What can happen when a laboratory doesn’t know that its electronic records leave a digital trace that the FDA can follow.

Categories: Regulatory Center
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Data Integrity Matters | Why is Data Integrity Important?

By May 10, 2017

Behind analytical data are humans – with pressures, emotional and personal needs to provide the best possible data for the biggest impact, personal pride, or simply a desire to make their lives easier. Do human or cultural factors affect scientists in regulated laboratories or operators in manufacturing areas?

Categories: Regulatory Center
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Data Integrity Matters | Introduction

By March 30, 2017

It’s not just about compliance any more. You’ve seen it in the headlines: 79% of Warning Letters issued by the FDA cite data integrity issues in 2016 (up from just 26% in 2013). But what… Read more >

Categories: Regulatory Center
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Chapter and Verse: USP 621 and You

By February 23, 2015

In August 2014, the United States Pharmacopeia and the National Formulary (USP-NF) put into effect new guidelines to “allowable adjustments” in its Chapter <621> (USP37-NF32 S1). And as of August 1, 2016 when USP 39… Read more >

Categories: General, Pharmaceutical, Technologies
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Compliance Can Be Complicated, But It Doesn’t Have to Be

By February 18, 2015

Compliance is required by every regulated industry and in nearly every nation. Whether it’s complying with strict regulations from the United States Food and Drug Administration, the European Directorate for Quality Medicines, or other regulators… Read more >

Categories: General
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