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. |
