HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems
HDA responds to FDA’s draft guidance on Verification Systems. A must-read.
Search Results for: requests for verification
Most Companies Will Do DSCSA Verification Wrong
Most companies will do verification wrong, because they haven’t read the DSCSA or FDA draft guidance…or RxTrace.
GS1’s Messaging Standard For Verification Of Product Identifiers
GS1’s new standard for verification messaging. Does it apply to you? Probably.
DSCSA: Verification Systems Draft Guidance
Verification Systems under the DSCSA are the things that FDA (and probably state) inspectors are going to look for whenever they visit your facilities from now on. Are you ready? This new draft guidance will help you.
What’s So Hard About Unique Identifier Verification?
Verification is arguably the most important concept in drug serialization and tracing regulations. What makes it so hard to get right?
DSCSA Verification and Suspect Product
Does a failed verification automatically force a product into the suspect product category? The answer might surprise you.
DSCSA Red Light Green Light: Verification Responses
There is an important debate going on over the last 9 months regarding exactly how many different answers companies should prepare to provide in response to a DSCSA verification request. Some say two: “Red light” or “Green light”. And others say three: “Yes”, “No”, or “It’s Complicated”. This might seem like a minor question, but … Continue reading DSCSA Red Light Green Light: Verification Responses
DSCSA: Saleable Returns Verification
The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future. Today I want to take a closer look at the results of the Saleable Returns Pilots … Continue reading DSCSA: Saleable Returns Verification
