Lab Compliance

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

16 February, 2020

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

20 December, 2019

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

13 November, 2019

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

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Strategies for Surviving an FDA Audit

10 October, 2019

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

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Enhancing Data Integrity in Clinical Research with Blockchain Technology

8 August, 2019

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

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Creating an Effective Validation Master Plan

11 June, 2019

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

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Data Integrity: The Importance of a Quality Culture

14 May, 2019

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

19 March, 2019

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

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Ensuring Data Integrity with the Allotrope Framework

22 January, 2019

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

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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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A Selection of Current Customers