January 2018, FDA Commissioner Scott Gottlieb issued the FDA 2018 Compounding Policy Priorities Plan on the FDA website. This communication provides a summary background on how the FDA became involved in compounding pharmacies, and a summary of how FDA will prioritize actions to protect the public health as obligated under DQSA. I found the following section particularly interesting: […]
Read MoreDid 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 […]
Read MoreDerek Fraits – Receives LEED Green Associate Certification
For Immediate Release (Indianapolis, Indiana; June 12, 2014). Performance Validation is pleased to announce that Mr. Derek Fraits has successfully completed certification as a LEED Green Associate. The Green Building Certification Institute administers this certification process. The LEED Green Associate credential is for professionals who want to demonstrate green building expertise in non-technical fields of […]
Read MoreData 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 […]
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 […]
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