What is a Unique Device Identifier (UDI)?
Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to:
Unambiguously identify a device for patient safety
Improve medical …
Have you ever come away from an audit feeling unsure of your own organisational processes? Do you sometimes feel that your organisation is alone or unique in the types of audit deficiencies observed? How …
Industry support of overdose prevention
This is blog 8 of 10 Blogs in the overdose awareness and overdose prevention series.
What is GxP compliance? And how does GMP/GxP compliance help with overdose prevention efforts?
GMP and GxP …
Snapshot of the Opioid Crisis (Legal Cases)
This is blog 6 of 10 blogs in the overdose awareness and overdose prevention series.
International Overdose Awareness Day (31st August) is rapidly approaching. It warrants a discussion of …
As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a supply and just in time, QikSolve have …
FDA Citation Tracking Tool Updated December 2020
I’m excited to share that QikSolve has a new tool to track and trend all FDA inspection and 483 citations from 2008 to 2015, the tool dynamically scrapes …
FDA Crackdowns on False Claims for Medicinal Cannabis Products
False Claims, Fake Medicines and Counterfeit News – Why the U.S. FDA is cracking down on cannabis-product advertising claims and unsubstantiated efficacy statements.
Are U.S. medicinal cannabis …
Fake medicines and substandard supplements are increasingly being distributed and consumed across the globe. This is partially due to thousands of unauthorised online pharmacies selling substandard medications, counterfeited pharmaceuticals and other fake drugs. It’s …
Counterfeit medicines — fake drugs and falsified medicines — are endangering lives.
How large is the problem of substandard medications and falsified pharmaceuticals? What are the global statistics of counterfeit medications entering countries across …
To supplement the draft guidance for industry on Request for Quality Metrics, The US FDA have released a Quality Metrics Technical Conformance Guide to recommend how quality data should be submitted. The document contains …
