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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 […]
Read MoreData 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 […]
Read MoreData 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 […]
Read MoreData Integrity – Audit Trail Review
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, […]
Read MoreData Integrity
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 […]
Read MoreDakota Schmitt Receives ASQ CQIA Certification
Milwaukee, Wis., — The Certification Board of ASQ (American Society for Quality) is pleased to announce that Mr. Dakota Schmitt, has completed the requirements to be named an ASQ-Certified Quality Improvement Associate, or ASQ CQIA. Dakota is a Validation Engineer with Performance Validation, a 100% employee owned company which provides professional, technical services to the life […]
Read MoreCritical Airflow in Compounding Facilities
Based on a review of FDA Form 483’s issued to compounding facilities for inspections that occurred January to July 2017, 22 separate citations have been identified for critical airflow visualization. Critical airflow is a key element in the protection of sterile product from contamination. A summary of these citations include: The design, construction, and operation […]
Read MoreComputer Software Assurance – Risk Assessment Takes Center Stage
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 […]
Read MoreCommissioning and Qualification – An Overview
Buildings and equipment used in the manufacture, processing, packaging, holding or storage of drug product are subject to the regulations set forth by the FDA in 21 CFR Part 211. These regulations are considered the minimum current good manufacturing practices (cGMPs), for the manufacture of human and animal drug products. Commissioning and qualification of these […]
Read MoreCo-Manufacturing
In a recently posted warning letter, the manufacturer of over-the-counter (OTC) oral rinses and oral moisturizing drug products received a citation concerning 21 CFR 211.42. The firm used the same manufacturing equipment to manufacture the GMP over-the-counter oral rinses and oral moisturizing drug products and numerous non-pharmaceutical materials (Co-Manufacturing) in your facility, including an industrial car care […]
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