Global Shop Solutions

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).… more


STARLIMS Validation

The Challenge

A pharmaceutical manufacturing company implemented a Laboratory Information Management System (LIMS) to electronically maintain their sample inventory, workflows, and laboratory information. The LIMS would collect, store, and report data and maintain FDA GxP and 21 CFR Part 11 compliance.… more


Environmental Monitoring System Validation

 

The Challenge

A biomedical research company purchased a web enabled enterprise wide building management system. The Trane Tracer Ensemble software allows remote access to monitor and troubleshoot building systems from a PC or phone device.   They installed environmental sensors for rooms, refrigerators, and freezers which send alerts in the event of a failure. … more


Computer 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.… more


Sage ERP Validation

Sage ERP Validation

The Challenge

A medical supply company was audited and found their enterprise resource planning (ERP) software system Sage 100 needed to be validated since it creates quality records for the client.  The customer used it only for Sales Orders and Vendor Purchases, so the entire software application did not need to be validated. … more


See you at the 2019 RAPS Convergence!

Performance Validation (PV) will be exhibiting in Booth 348 at the RAPS Regulatory Convergence 21-24 September 2019 in Philadelphia.

Sally Zimmerman and Monte McMartin will be representing Performance Validation and are looking forward to discussing medical device validation and system compliance with you.… more


Sage X3 FDA Compliance Validation

Sage X3 ERP Validation

The Challenge

A medical technology company was upgrading their enterprise resource planning (ERP) software system to the latest Sage X3 platform in order to improve their efficiencies in accounting, distribution, and manufacturing.  They would be implementing the Sage X3 platform as a SaaS (Software as a Service) with a browser-based interface. … more


CGMP Consultants Recommended in FDA Warning Letters

In a review of the latest one hundred (100) FDA Warning Letters issued as of May 17, 2019, nineteen (19) included the section header “CGMP Consultants Recommended” within the content of the letter, followed by these statements:

 “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging consultants qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements.”more


PV @ Midwest Society of Quality Assurance Annual Meeting – 6-7 August 2019

PV’s  Kevin Marcial will be presenting “A Practical Guide to Risk Based Computer System Validation” at the Midwest Society of Quality Assurance Annual Meeting August 6-7, 2019. Come to Indianapolis to learn about risk-based CSV and other great topics in the QA world.… more


Kaye Validator AVS ICAL Software Validation

Kaye Validator AVS ICAL Software Validation

The Challenges

A manufacturing division of a major pharmaceutical corporation owned and operated a number of Kaye Validator thermal validation systems. Historically, the facility’s Metrology department had outsourced the scheduled calibration of the Kaye Validators and their sensor input modules (SIMs) to the vendor, which limited their control over the time it took to return the units to service.  more