User Rating: 0 / 5

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive

I guess by now the rumors are true and the FDA has recently (late 2015) announced that it will begin much more stringent inspections for compliance to 21 CFR Part 11 regulations related to and concerning electronic records, audit trails concerning metadata, and signatures that need to be actual and trustworthy, plus validation of products.

5 1 1 1 1 1 1 1 1 1 1

Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

Peter's Recent Articles

User Rating: 0 / 5

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive

Refrigerator monitoring for cold chain drugs is one of the main essentials for insuring efficacy and safety of the drugs stored within these units, and a compliance requirement from the FDA, CDC, WHO, etc.

4.5 1 1 1 1 1 1 1 1 1 1

Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

Peter's Recent Articles

User Rating: 0 / 5

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive

Even though many of the sections that make up the new combined FSMA regulations are published and in a complete form, this year we will see two new sections being released as a final ruling.

5 1 1 1 1 1 1 1 1 1 1

Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

Peter's Recent Articles

User Rating: 0 / 5

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive

When we use the word Smart and couple this with Solutions, then add in the term Last Mile, or Patient Mile, it seems everything you read has either a different solution, or interpretation related to the need!

3.5 1 1 1 1 1 1 1 1 1 1

Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

Peter's Recent Articles

User Rating: 0 / 5

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive

The ICH and other globally focused organizations are working diligently to introduce more consolidated forms of quality regulations, like the ICH Q10, for the management of the quality of drugs related to cold chain distribution and drug security.

5 1 1 1 1 1 1 1 1 1 1

Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

Peter's Recent Articles