Testing and Risk-Based Computer System Validation

Performance Validation recently featured an introductory post on risk-based computer system validation. It is an approach by which one can focus the validation effort on critical business and regulatory requirements and reduce the need for excessive testing and redundancy. A fundamental aspect of this approach is to leverage software vendor functional testing. This permits the […]

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Promoting a Validation Mindset: Overview

Among our cadre of validation engineers and specialists we offer an experienced and knowledgeable team of personnel whose area of expertise is focused on the delivery of validation services for computerized systems. With decades of combined experience in the computerized systems validation field, our team has gained an informed point of view of what constitutes […]

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Part 11 Compliance Considerations for SCADA Systems

Supervisory Control and Data Acquisition (SCADA) systems are tremendous assets in the pharmaceutical, medical device, and other FDA regulated manufacturing industries, providing cost efficiencies and improving the consistency of product quality. They have also enabled the industries to move from hardcopy to electronic production records. Systems used for manufacturing pharmaceuticals, medical devices, and other regulated […]

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Managing Data Integrity Risks for SCADA Systems

SCADA (Supervisory Control and Data Acquisition) software vendors have historically served industries that require tight controls over system configurations and data records.  As a result, modern SCADA software systems have evolved to provide a robust set of tools intrinsically designed to prevent the intentional or unintentional undetectable alteration of system data.  Most notably, the integration […]

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FDA Proposed Rule for a GLP Quality System

Those of us who have worked in pharmaceuticals or medical device are familiar with the concept and requirements of a Quality System. On August 24, 2016, the FDA issued a proposed a rule to the Good Laboratory Practices (GLPs, 21 CFR part 58), titled  “Good Laboratory Practice for Nonclinical Laboratory Studies”. The concept is akin to […]

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Did We Validate The System’s Intended Use?

If you are wondering whether the validation you are working on has covered the appropriate functionality, consider one of the primary criteria cited by the FDA for validating is the intended use of the software which is used as part of the production and/or quality system . Over the last ten years, numerous FDA Form […]

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Data Integrity Risks on SCADA Systems

SCADA (Supervisory Control and Data Acquisition) software vendors have historically served industries that require tight controls over system configurations and data records.  As a result, modern SCADA software systems have evolved to provide a robust set of tools intrinsically designed to prevent the intentional or unintentional undetectable alteration of system data.  Most notably, the integration […]

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Data Integrity Issues

In a recently posted FDA warning letter USV Limited, Mumbi India, was cited for two instances of data integrity issues.  Specific citations identified in the warning letter include: Citation 1- backdating, using backdated printouts, and submitting them as raw data. Citation 2- Lack of control of computer systems, disabled audit trail function, use of shared log in […]

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Data Integrity & Audit Trails

In April 2016 the FDA released the draft version of “Data Integrity and Compliance with cGMP, Guidance for Industry.”  Among the topics covered in the guidance was ‘audit trails’. The answers to these two questions “How often should audit trails be reviewed?” and “Who should review audit trails?” may represent a significant update to the […]

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