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The Astrix Blog

Expert news and insights for scientific & technology professionals.

Laboratory Compliance

Laboratory Relocation Best Practices

The pace of change in the pharmaceutical and biotech industries means that […]

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Best Practices for Instrument Validation and Qualification

Analytical instruments provide important scientific data about manufactured products that serves to […]

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Moving Your LIMS to the Cloud: What You Need to Know

Modern laboratories in all industries are under intense pressure to reduce costs […]

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Tips for Maintaining Laboratory Data Security

On June 27th, 2017, a massive ransomware attack infiltrated computer systems and […]

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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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FDA’s Guidance on Genetic Testing: What You Need to Know

In traditional medical care, diseases are typically detected via chemical changes associated […]

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Common Mistakes in Computer System Validation

Modern scientific laboratories increasingly rely on computerized informatics systems (e.g., LIMS, ELN, […]

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Using Electronic Batch Records (EBR) to Optimize Manufacturing Efficiency

In an effort to ensure product quality and patient safety, the pharmaceutical […]

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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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What the New FDA Guidance for ICH GCP E6 R2 Means for Sponsors and CROs

FDA Guidance for Good Clinical Practice (GCP) is an international quality standard […]

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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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What the FDA Guidance on Data Integrity Means for Your Lab

Regulatory agencies worldwide are increasingly focusing their efforts on data integrity in […]

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