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

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

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

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


Cell Culture Purification Suite Qualification

Cell Culture Purification Suite Qualification

The Challenge

A client contacted Performance Validation requesting assistance with qualification of additions and modifications to an existing cell culture purification suite to expand the product line capabilities of a newer acquisition facility on a tight production shutdown window.

Additionally, this client requested assistance with replacement of their obsolete washers and autoclaves, expansion of their quality control lab facility, and changes to their utility systems to accommodate the resultant increased production rates.… more


Dry Product Packaging Line Qualification

boxes on assembly line

The Challenge

A client contacted Performance Validation requesting assistance with qualification of a new product packaging line for a bagged dry product to allow for serialization and reduction in personal protective equipment (PPE) required by operations. This system was to be installed in a parallel room with tie-in to the existing packaging line to allow for continued packaging operations during construction and qualification activities.… more


Hospital Building Commissioning

hospital

The Challenge

A client contacted Performance Validation requesting assistance with 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 well as space for research labs, lab support, offices, and staff support. … more