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Welcome to Coldchain Technology Services |
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Providing Comprehensive Solutions in Cold Chain Management |
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Contact Us At: (888) 687-2553 |
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Regulatory Consulting: Coldchain Technology
Services helps companies develop and implement sound
GMP compliance
strategies. Coldchain
Technology Services can assist your firm with FDA pre and post approval
inspections, QA/QC documentation review, documentation
generation, regulatory interpretation, and
submissions.
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| Quality Systems:
Coldchain Technology Services can assist your group in the development of
GMP Quality Systems including Standard Operating Procedures (SOPs), batch
records, change control, revalidation, documents management, complaints
management, and annual product reviews. |
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Commissioning: During commissioning and start-up of a new
facility, documentation critical to the validation effort should be compiled and
organized. Poor commissioning negatively impacts the validation effort and can
result in persistent compliance problems. Coldchain
Technology Services assists in many activities related to commissioning
and start-up of new facility such as preparation of specifications and
engineering turn over packages (ETOPs).
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| Training: Coldchain
Technology Services offers on-site training. Common topics include
validation protocol generation and execution, FDA pre and post approval
inspections, QA / QC program development, and Part 11 compliance. Coldchain Technology Services also can develop
internal training procedures. |
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Auditing: Coldchain Technology Services
offers supplier/vendor audits, contract laboratory audits, and general GMP
compliance auditing. Audits are tailored to meet the specific needs of your
company.
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| Logistics:
Coldchain Technology Services
specialize in warehouse and transportation management. Based on your
specific needs, we can assist your company in WMS, design, environmental control
design, and inventory management.
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Validations: Coldchain Technology Services
offers validation generation and execution of transportation
procedures, shipping procedures, environmental storage facilities, and software
systems. We can assist your quality control department with every aspect
of the validation process. We specialize in temperature mapping of any
size of environmental storage facility.
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SCADA Development: Coldchain Technology Services
utilizes WonderWare for all of it's custom monitoring
applications. As a certified WonderWare system integrator, we can utilize
this engineering experience to help you achieve your graphical user interface
requirements. Our engineers have development experience in
Part 11,
control, and monitoring applications.
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