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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 MoreAshley Saberniak receives ASQ CQIA Certification
For Immediate Release (Indianapolis, Indiana; March 4, 2016). Performance Validation is pleased to announce that Ms. Ashley Saberniak has successfully completed certification as a Certified Quality Improvement Associate. The Certified Quality Improvement Associate is a professional who understands quality tools and their uses and participates in quality improvement projects. The CQIA requries two years of work […]
Read MoreArtificial Intelligence and Machine Learning
In the world of commissioning, qualification, and validation for life science companies our world its pretty simple – you make a regulated product, you qualify the facility, the equipment, you validate the manufacturing process, and do change controls as necessary for equipment, facility, or process changes with updates to FDA depending on the magnitude of […]
Read MoreLessons Learned from FDA Warning Letters
April 2018 (week of 4/23/18) three cGMP warning letters were posted by FDA. The most interesting warning letter was to a Chinese API manufacturer for an inspection from October 2017 and provides some interesting lessons learned. This API manufacturer promised FDA to improve controls over laboratory computerized systems to prevent unauthorized access or changes to data (data integrity) […]
Read MoreAmerican Society for Quality Certifications
Indianapolis, IN (June 7, 2013) Performance Validation, a nationwide leader in providing validation, commissioning, and quality services, today announced that Kristin Beckman successfully obtained certification as ASQ Certified Quality Auditor (CQA), and Evelyn Chrivia and Julie Hart successfully obtained certification as a Certified Quality Improvement Associate (CQIA). ASQ’s Certified Quality Auditor is a professional who […]
Read MoreAlex Whittaker – Certified Quality Auditor
For Immediate Release (Indianapolis, Indiana; July 21, 2017). Performance Validation is pleased to announce that Ms. Alex Whittaker has successfully completed certification as a Certified Quality Auditor. Alex is a Validation Specialist with Performance Validation and is responsible to assist in the implementation, monitoring, and continuous improvement of our Quality Management System at a divisional […]
Read More503B – Pre-registration Consulting
The Challenge A pharmacist seeking to build a new 503B Outsourcing Facility requested assistance in the understanding and implementation of current good manufacturing practices (cGMPs) and the FDA risk based inspection processes. Background: In 2012, the CDC and USFDA investigated a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free […]
Read More503B Electronic Record Data Integrity
For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not […]
Read More503B Data Integrity Concerns
For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not […]
Read More21 CFR 211.42 – Buildings and Facilities
A review of FDA citations for 21 CFR 211.42 Subpart C Buildings and Facilities over the past 5 years (2018-2014) from the FDA Turbo data was conducted by Performance Validation. Our analysis identified that the highest frequency of citations within the buildings and facilities subpart were consistently attributed to two code sections: The citations to these two sections are […]
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