The Challenge A medical technology company with no previous Computer System Validation (CSV) experience needed to complete the validation of their Global Shop Solutions (GSS) enterprise resource planning (ERP) computerized system in accordance with 21 CFR 820 (FDA Quality System Regulation) and 21 CFR Part 11 (Electronic Records, Electronic Signatures). The ERP software would be […]
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The Challenge: A large Fortune 500 company required Critical Airflow Visualization testing (Smoke Studies) on a new aseptic filling line with active RABS barrier configuration. Additionally, modifications to two existing aseptic filling lines were completed in conjunction with the new filling line. The critical supply chain required completion of airflow visualization in a short window. The video […]
Read MorePerformance Validation has extensive experience with controlled temperature and humidity storage mapping projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries. These projects included mapping studies using PV’s own inventory of wireless Vaisala temperature and humidity data loggers. Performance Validation resources have expertise with determining logger placement for mapping, identifying […]
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The Challenge: A large Fortune 500 company required Critical Airflow Visualization testing (Smoke Studies) after an upgrade to a high-volume filling line with new RABS barriers. Additionally, there were multiple changes to the layout of the line and room were completed in conjunction with the upgrade. The video evidence of the Critical Airflow Visualization studies […]
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The Challenge A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the qualification of a suite of DeltaV automation modules that support continuous manufacturing facilities around the globe. The suite consisted of 38 DeltaV modules and phases that were interconnected and worked in tandem to automate the continuous manufacturing process. The modules […]
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Overview A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new portable deblistering machine for use in a pharmaceutical packaging facility. This deblistering machine allows for the recovery of drug products (in tablet or capsule form) from blister cards that have been rejected for issues not […]
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The Challenge A client contacted Performance Validation requesting assistance with the commissioning of a pediatric research center renovation project. The research center was to be located within a renovated 2nd floor of an old building that is part of a children’s hospital and was to include exam space for patients participating in clinical research programs as […]
Read MoreThe Challenge A large mid-western Medical Device company responding to multiple FDA inspections had not made adequate progress towards remediating their quality systems. The company had several hundred products that required remediation and a deadline of 18 months to complete this work. The Solution Performance Validation provided a dedicated consultant who participated with the client’s […]
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The Challenge: A large manufacturing company required Critical Airflow Visualization testing (Smoke Studies) on two new isolator filling lines and one RABS filling line. The critical supply chain required completion of airflow visualization in a short window. The video evidence of the Critical Airflow Visualization studies are typically reviewed during regulatory inspection and thus must […]
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