3PL - Priority Solutions International, Awarded FDA Certification for PowerHouse
Change Control, Lot/Expiration and Configurability - WMS Life Sciences Functionality PSI Needed to Serve Pharma Accounts
New Jersey - USA: QSSI has announced that Priority Solutions International (PSI) has received their FDA Compliance certification after having completed a full regulatory audit of their PowerHouseWMS software and Operating Procedures.
The selection and implementation of a new warehouse management system to run PSI's 3PL services organization had far reaching implications. Not only was PSI implementing a new WMS, they also needed a software partner that could assist them with their FDA compliance requirements and support the final validated solution. Because PDMA, cGMP and regulatory compliance is interwoven throughout their Standard Operating Procedures (SOPs), complete FDA systems validation was required for PSI to be awarded approvals from major pharmaceutical companies following full quality audits.
To manage their customer's business processes PSI required a solution that had proven, configurable 3PL functionality, flexible lot control, expiration date management and compliance features like change control tracking. And they needed a partner with a lineage of successfully supporting their pharmaceutical clients with outstanding service. The solution was PowerHouseWMS from QSSI.
Following QSSI's Results Implementation Methodology, PSI was able to learn the PowerHouse system, define their requirements, and easily configure their warehouse processes. Concurrent with these activities was the development of their System Design Specification and validation Test Plan.
The validation test plan, in addition to many other processes, examined three critical building blocks for regulatory compliance; the three Q's (Installation, Performance, and Operational Qualification). Following the test strategy through each qualification phase, PSI and QSSI successfully demonstrated that PowerHouseWMS met FDA 21 CFR Part 11 requirements for certification.
About Priority Solutions International: Priority Solutions International is a non-asset based supply chain management company specializing in meeting the logistics requirements of the Life Sciences industry. The company was formed through a merger between Priority Air Express (PAX) of NJ and Distribution Solutions International (DSI) of MI in 2005. PAX and DSI were both recognized leaders in the healthcare supply chain industry after years of providing PDMA compliant sample management services to the top pharmaceutical companies in the United States. Combining the strengths of both companies, Priority Solutions International clients have access to a nationwide network of qualified local delivery resources, multiple warehouse locations, international air freight forwarding and a wide variety of value added services. Priority Solutions International was acquired by ThermoFisher Scientific in October 2007. http://www.prioritysolutions.com/
About QSSI: QSSI delivers advanced Warehouse Management, Transportation Optimization and Logistics solutions to support the strategic needs of growing companies. Founded in 1986, QSSI deploys Innovative Supply Chain solutions internationally leveraging a network of certified partners to meet your needs. Complementing its WMS and Logistics products, QSSI provides Labor Management, Slotting, Voice, Process Management and Integration software suites and hardware to deliver turnkey solutions with exceptional results. For more information please visit: www.qssi-wms.com.
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