Glossary

Cold Chain

The temperature-controlled supply chain that keeps a product within its required temperature range from manufacture to use.

Cold-chain integrity is demonstrated through qualified packaging, lane qualification, continuous monitoring and a documented response to any excursion.

For many biologics the cold chain is the single biggest risk to product quality in transit.

See it live in 25 minutes.

Eight guided flows: compliance review, DPS screening, Part 11 e-signature, custody chain, breach prediction, GDPR erasure and the validation report. Then a 30-day pilot on your own programme at £15k, extendable a month at a time to three months, fully creditable.