The Food and Drug Administration (FDA) has recently proposed dramatic changes to the current Computerized System Validation (CSV) approach that is being used by most companies in the Life Science Industry...
https://kenx.org/wp-content/uploads/2021/06/image.1.png211432Jonathan Driscollhttps://kenx.wpmudev.host/wp-content/uploads/2020/07/Insights-Logo22-1.pngJonathan Driscoll2021-06-17 00:25:482021-06-17 00:25:48How to Benefit from the Computer Software Assurance Guidance
Software as a Service (SaaS) is a cloud computing delivery model that promises various benefits, but also comes with unique risks. The life science sector has a very slow cloud adoption rate…
https://kenx.org/wp-content/uploads/2021/06/Figure-1.jpg371743John Toccihttps://kenx.wpmudev.host/wp-content/uploads/2020/07/Insights-Logo22-1.pngJohn Tocci2021-06-07 19:08:202021-06-07 19:10:06GxP Considerations for Compliance in the Cloud
Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process…
In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that…
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In drug manufacturing, keeping track of data is crucial for the drug’s approval from the FDA. The “Continued Process Verification” (CPV) data needs to be maintained for ensuring that the product outputs are within predetermined quality limits…
https://kenx.org/wp-content/uploads/2020/09/Screen-Shot-2020-09-23-at-11.24.32-AM.png271752Jonathan Driscollhttps://kenx.wpmudev.host/wp-content/uploads/2020/07/Insights-Logo22-1.pngJonathan Driscoll2020-09-23 15:23:242020-09-23 19:37:40CPV Batch Record Digitization: Challenges and Role of AI
A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation…
https://kenx.org/wp-content/uploads/2020/08/insight-photo.png293766Jonathan Driscollhttps://kenx.wpmudev.host/wp-content/uploads/2020/07/Insights-Logo22-1.pngJonathan Driscoll2020-09-02 14:35:342020-09-02 14:35:34The Big Reshuffle — Impact Assessments and System Criticality
Since the publication of ICH Q9[1] in 2005, the pharmaceutical industry is encouraged to take a risk-based approach to the control and management of product quality. The expectation that Quality Risk Management (QRM) is integrated into the Pharmaceutical Quality System (PQS) is further developed in ICH Q10 [2]. ICH Q10 objectives are to achieve…
https://kenx.org/wp-content/uploads/2020/07/unnamed.png4861128rculverhttps://kenx.wpmudev.host/wp-content/uploads/2020/07/Insights-Logo22-1.pngrculver2020-07-07 15:10:002020-07-30 05:13:21Risk Management Tied Up With A Bow Tie
How to Benefit from the Computer Software Assurance Guidance
The Food and Drug Administration (FDA) has recently proposed dramatic changes to the current Computerized System Validation (CSV) approach that is being used by most companies in the Life Science Industry...
GxP Considerations for Compliance in the Cloud
Software as a Service (SaaS) is a cloud computing delivery model that promises various benefits, but also comes with unique risks. The life science sector has a very slow cloud adoption rate…
Drug Product Validation
Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process…
Biosafety Cabinet Qualification
Despite having robust design and environmental monitoring, cleanrooms are at risk for several sources of contamination…
Is Your Site Ready for Data Integrity?
In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that…
CPV Batch Record Digitization: Challenges and Role of AI
In drug manufacturing, keeping track of data is crucial for the drug’s approval from the FDA. The “Continued Process Verification” (CPV) data needs to be maintained for ensuring that the product outputs are within predetermined quality limits…
The Big Reshuffle — Impact Assessments and System Criticality
A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation…
Risk Management Tied Up With A Bow Tie
Since the publication of ICH Q9[1] in 2005, the pharmaceutical industry is encouraged to take a risk-based approach to the control and management of product quality. The expectation that Quality Risk Management (QRM) is integrated into the Pharmaceutical Quality System (PQS) is further developed in ICH Q10 [2]. ICH Q10 objectives are to achieve…