Corrective and Preventive Action (CAPA) is a key process within a pharmaceutical quality management system. It is the process of identifying and documenting corrections and improvements to systems and processes to reduce the risk of a deviation, non-conformance or quality issue occurring or recurring (hereafter referred to as an ‘issue’). A CAPA record must include…
Data integrity continues to be a focus during US FDA inspections. A number of warning letters issued by the FDA in 2022 highlight the importance of Data Integrity compliance. In the warning letters issued, the FDA references the FDA’s guidance on Data Integrity; “Your quality system does not adequately ensure the accuracy and integrity of…
FDA Citation Tracking Tool Updated October 2022 I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 20011 to 2021, the tool dynamically scrapes data from various live websites and databases and provides a single, secure portal which to track and trend data, or…
This popular blog has been updated in 2022 with the latest FDA data. 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 updated their free tool that scrapes data from various websites…
Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials. The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or processed (e.g. prion diseases). Transmissible Spongiform Encephalopathy (TSE) is a prion disease that can affect…
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