Laboratory Compliance

Best Practices for Computer System Validation

17 June, 2018

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

8 June, 2018

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

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

13 December, 2017

Moving your LIMS to the Cloud is a key decision for many […]

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

28 September, 2017

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

1 August, 2017

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

11 May, 2017

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

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