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The Astrix Blog

Expert news and insights for scientific & technology professionals.

Lab Compliance

Agile Regulatory Compliance: How quickly do your current processes allow you to respond to regulatory changes?

Staying current with ever-changing regulatory compliance regulations can be an overwhelming and […]

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“Lean Methodologies” Revolutionize Pharma Quality Control Labs

The pharmaceutical quality control (QC) laboratory serves one of the most vital functions in pharmaceutical production […]

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Creating Validation Documentation for BIOVIA Applications

Computer systems have produced significant changes to business processes in every industry […]

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Strategies for Surviving an FDA Audit

As part of its mission to ensure public safety, the FDA inspects […]

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Trends in FDA Data Integrity 483s and Warning Letters for Pharmaceutical Companies

The manufacture of pharmaceutical drugs is a highly complex process that involves […]

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LIMS Master Data Best Practices Part 3: Maintenance and Scalability

Master data design has very important impacts over the lifecycle of a […]

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Reducing the Cost of Computer Systems Validation Efforts Through Risk Assessment

Computerized systems have been widely adopted by the pharmaceutical industry and are […]

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Enhancing Data Integrity in Clinical Research with Blockchain Technology

Verification of data integrity is a critical part of the FDA’s mission […]

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Creating an Effective Validation Master Plan

The Food and Drug Administration (FDA) is tasked with protecting the public […]

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Data Integrity: The Importance of a Quality Culture

Verification of data integrity is a critical part of the FDA’s mission […]

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What the FDA’s New Guidance on Data Integrity Means for Pharmaceutical Companies

Data integrity is an important consideration in today’s pharmaceutical GxP laboratories. Compliance […]

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Ensuring Data Integrity with the Allotrope Framework

Data integrity is a hot topic as we move into 2019 and […]

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Best Practices for Computer System Validation

Computer system validation (CSV) is a documented process that is required by […]

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Navigating Global Regulations and Guidance Around Data Integrity

Data integrity provides assurance that data records are reliable and accurate. Regulations […]

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What the New FDA Guidance on Electronic Records and Signatures Means for Clinical Trials

The digital age is upon us. The FDA has acknowledged the increasing […]

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What the FDA’s Quality Metrics Reporting Program Means for Your Lab

Quality metrics are utilized throughout the pharmaceutical industry to assure product quality […]

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