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


Pharmaceutical Manufacturer – Commissioning & Qualification

Overview

A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with commissioning and qualification of a fleet of innovative mobile research units for use in clinical trial research to meet an accelerated schedule. The mobile research units provided several functions critical to conduct life-saving clinical trials by enabling ‘pop-up’ research centers to connect with high-risk patients in locations with high infection rates.… more


Pharmaceutical Manufacturing – Autoclave Steam Sterilization

Pharmaceutical Manufacturing – Autoclave Steam Sterilization:

The Challenge

A pharmaceutical manufacturing company recently had several autoclave sterilization cycles that were very long in duration, resulting in premature failure of stopper and seal RTP bags. The cycles had been developed and validated years ago and the company did not have much in-house autoclave/sterilization expertise.… 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


DeltaV Continuous Manufacturing Automation Qualification

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.… more


IATA Mapping of Airline Cargo Facilities

IATA Mapping of Airline Cargo Facilities

The Challenge

A large international airline company needed to have temperature controlled storage at two major U.S. airports for the transport and short-term storage of Time and Temperature Sensitive Products (TTSPs).  As part of IATA’s (International Air Transport Association’s) certification process, a temperature mapping is required of all temperature controlled storage areas to be used for this purpose. … 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


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


IBM Clinical Development EDC Validation

IBM Clinical Development EDC Validation

The Challenge

A global organization that develops, manufactures and sells diagnostic instruments and related software needed validation for their cloud based Electronic Data Capture “EDC” platform, “IBM Clinical Development” to help reduce the time and cost of clinical trials.  Their clinical sites would enter study data into the software and it would expedite their data review and processing.more


Deblistering Equipment Qualification

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 related to product quality (e.g.… more