Tag: software validation process

Auditing Transport Providers and Cold Chain Vendors

Auditing Transport Providers and Cold Chain Vendors Auditing Transport Providers and Cold Chain Vendors The pharmaceutical industry has increasingly relied on outsourced transport providers and cold chain vendors to ensure the integrity of products throughout their supply chain. Maintaining compliance…

Hold Time Extension Justification: What Data Do You Need?

Hold Time Extension Justification: What Data Do You Need? Hold Time Extension Justification: What Data Do You Need? Step 1: Understanding the Context of Hold Time Studies Hold time studies are pivotal in the pharmaceutical and biopharmaceutical industries. They ensure…