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The recent focus has been on regulations relating to the US Federal Drug Quality and Security Act of 2013 (DQSA) Title II Drug Supply Chain Security Act (DSCSA), Chinese SFDA, Brazilian ANVISA and emerging requirements in Europe.

Projects have included traceability, including serialization for the United States, Europe, China, Turkey, Brazil, Argentina, Jordan, Saudi Arabia, South Korea, India and other countries. 


Projects have delivered (1) strategy, (2) project roadmap and plans, (3) User Requirement Specification (URS) for (a) enterprise serialization, (b) packaging systems, (c) warehouse/shipping (referred to as EDGE), and (d) regulatory reporting such as e-pedigree, (4) contract manufacturer and logistics provider requirements and governance, (5) compliance with global regulatory requirements, (6) functional and design specifications, (8) business system and packaging designs and architectures, (9) pilot planning and scenarios, (10) GAMP based validation, and (11) vendor selection.

Projects have included solutions involving serialization, track and trace, electronic pedigree (e-Pedigree), country traceability reporting (i.e., Turkish Ministry of Health, China, etc.), radio frequency identification (RFID), barcoding and scanning, GS1 electronic product code information services (EPCIS), supply chain, warehousing and Electronic Data Interchange (EDI). Pharma Logic Solutions, LLC is a longstanding Solution Provider for GS1 US Healthcare.

Projects comply with leading regulatory authorities, including:

- U.S. Food and Drug Administration (FDA),

- Canadian Health Products and Food Branch Inspectorate
  (HPFBI) and Therapeutic Products Directorate (TPD),

- European Medicines Agency (EMA),

- UK Medicines and Healthcare Products Regulatory
   Agency (MHRA),

- Brazil Agência Nacional de Vigilância Sanitária (ANVISA),

- French Agence Française de Sécurité Sanitaire des
  Produits de Santé (AFSSAPS),

- Gulf Cooperation Council (GCC), representing United
  Arab Emirates (UAE), Bahrain, Saudi Arabia, Oman, Qatar,
  Kuwait

- Italian Agenzia Italiana del Farmaco (AIFA),

- Japanese Ministry of Health, Labor and Welfare


Strategy, business and user requirements, designs and implementations have included solutions from SAP (ECC, SCM, Aii, OER, Aie), JD Edwards, Oracle (OPSM, OPM), Manhattan Associates, MAPICS, Acsis (ProducTrak), Axway, rfXcel, Frequentz (formerly IBM Traceability Server), Systech, Optel Vision (TrackSafe, Line Master, PharmaProof), Cognex, Mettler Toledo, Seidenader (Körber Medipak), Antares Vision (Xyntek), Laetus, ROC-IT Solutions, TAKE Solutions, Uhlmann, Nosco, Werum PAS-X, Tracelink, Videojet and others.

Adjacent projects have included automating order-to-cash processing using Electronic Data Interchange (EDI), anti-counterfeiting and brand protection strategies, packaging line Risk Evaluation and Mitigation Strategy (REMS), enhanced business integration with contracted service providers and related Standard Operating Procedure (SOP) and process enhancements.

It's not surprising then that the Pharma Logic Solutions is leading change in life sciences supply chain, packaging and drug authentication. 

Contact us to discuss your needs and contrast the Pharma Logic Solutions solutions against previous providers to see why our approach is the perfect solution. 

Areas of focus include:

Strategy Engineering

  • Serialization
  • Traceability
  • Electronic pedigree (e-pedigree)
  • Supply chain refinement
  • Barcoding
  • Radio Frequency Identification (RFID)
  • Technology Architecture Assessment
  • Business Process Assessment & Re-engineering

Application & Integration Vendor Selection

  • Packaging and labeling systems
  • Custom Application Development
  • Enterprise solutions

Project Resource Assistance

Supplemental resources to assist in project and departmental needs
 

Contact us (info@pharma-logic.com) to discuss your needs and contrast the Pharma Logic Solutions options against other providers to see why our approach is the ideal solution for your business. 

 

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Updated: Thursday November 23, 2017.