Pharma Logic
Solutions, LLC (www.pharma-logic.com) assists
life Sciences, Biologic, Pharmaceutical
Distributors, Pharmacies and Healthcare
Providers to implement
solutions and gain
business advantages from product traceability,
serializations, packaging and supply chain
intelligence.
Pharma Logic Solutions
is comprised of highly experienced consultants
and is specifically focused on secure supply
chain solutions in life sciences. Since 2007, it
has completed serialization and traceability
projects for over 2 dozen leading life sciences
companies. Clients have included biologics,
small molecule, specialty and low margin
generics, including but not limited to both
large and small companies.
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
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.
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 so
many industries.
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 to
discuss your needs and contrast the
Pharma Logic Solutions solutions against previous providers to
see why our approach is the
ideal solution. |
