Category: CSV

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

Data integrity demands a great amount of attention in the life science industry. This is now truer than ever with increased focus from the FDA, EU, and industry standards on data integrity issues and best practices. Audit trails for computerized systems are required for all FDA / EU regulated systems. It must capture the creation, […]

Data integrityIn a recently posted warning letter a number of issues were identified concerning data integrity of laboratory results.  These results included:Laboratory personnel used a software function “inhibit integration” without scientific justification. As identified in the warning letter: Inhibiting integration at various points during release testing for commercial batches is not scientifically justified. It can mask identification […]

Regulatory compliance activities, such as Computer System Validation (CSV), can often be burdensome and challenging if they are approached without risk assessment. Often CSV deliverable completion is driven by procedures that are not designed to account for risk in relation to system, requirement, and processes. It tends to be a process focused more on documentation […]