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On March 11 FDA Commissioner Scott Gottlieb provided a statement in the request for new FDA Funding. The full FDA statement is available here. Below is the excerpt concerning funding requested to Strengthen the FDA’s oversight of compounded drugs to help secure patient safety: The practice of compounding medicine can provide important public health opportunities. The FDA’s […]
Read MoreFDA Devices Inspection Summary – FY 2013
A review of the Inspection Observation Summary for FY2013 was conducted with a focus on inspections of Devices. From 10-1-12 to 9-30-13 approximately 1099 device 483’s were issued and a total of 4393 citations were referenced. This is approximately the same number of 483’s that were issued in 2012 (N=1090), however the number of citations referenced in […]
Read MoreFDA 2018 Compounding Policy Priorities
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 […]
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