Tom McDevitt's Contact Details

Tom McDevitt's Company Details

Pharma Logic Solutions

N/A, N/A, N/A • 100 - 249 Employees
Management Consulting

Pharma Logic Solutions, LLC is a life sciences industry leading provider of strategy, requirements and designs for securing the global drug supply chain. Providing consulting services leveraging extensive experience and lessons learned to facilitate compliance with traceability, including serialization (and barcoding), e-pedigree, drug serialized numeric identifier (SNI), medical device unique device identifier (UDI). Pharma Logic Solutions, LLC has helped organization navigate the US Federal Drug Quality and Security Act of 2013 (DQSA) and Drug Supply Chain Security Act (DSCSA), the now preempted California e-pedigree, European country requirements for the European Directive 2011/62/EU known as the Falsified Medicines Directive (FMD), Turkey, Argentina, South Korea, China, Brazil, India, Jordon, and others. Projects have involved solutions from SAP (ECC, SCM, Aii, OER, Aie), JD Edwards, Oracle (OPSM, OPM), MAPICS, Acsis (ProducTrak), Axway, rfXcel, Frequentz (former IBM InfoSphere Traceability Server), Optel Vision, Systech (Guardian, Advisor, Sentri), Cognex, Mettler Toledo, Seidenader (Körber Medipak), Antares Vision, Laetus, ROC IT Solutions, TAKE Solutions, Uhlmann, Nosco, Werum (PAS-X), Tracelink and others.Projects have delivered (1) strategy, (2) project roadmap and plans, (3) encoding and serial number management governance, (4) contract manufacturer and logistics provider requirements and governance, (5) user/business requirements specifications (URS), (6) compliance with global regulatory requirements, (7) functional specifications, (8) business system and packaging designs and architectures, (9) pilot planning and scenarios, (10) validation scripts (including IQ, OQ, PQ), and (11) vendor selection. Other life sciences projects have included the design of packaging execution systems (PES), optimizing clinical supply chain, raw material and API tracking, and process improvement in warehousing and distribution.