Tag Archives: CSV

20Feb/19
CSA IMAGE FOR CC

FDA Shares a New Approach to CSV

An Straight from the Source Webinar

The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to improving digital capability, product quality, and patient safety and is working swiftly to reverse this trend.

Join us for a live webinar on March 7th at 1pm Eastern.  We will discuss FDA’s perspective on Computer Software Assurance (CSA) including:

  • FDA’s upcoming Guidance on CSA for Manufacturing, Operations, and Quality System Software
  • Applying critical thinking and risk-based principles to support technology modernization.
  • Identifying Acceptable Records of Assurance
  • Leveraging CSA to accelerate digital transformation

Meet Your Trusted Sources

Dan and Cisco 2019 Webinar

 

 

 

 

 

 

Please Note:  This webinar is limited to the first 100 registrants.

Can’t make the live session? No problem!

Register for the live session and receive access to the on-demand recording!

register

19Jul/18
Validation - original (1)

At 21, Computer System Validation Comes of Age

Stop Validating Computer Systems to Death!

By: Daniel R. Matlis, President

“FDA emphasizes that manufacturers are responsible for the adequacy of the software used in their devices and activities used to produce devices.  When manufacturers purchase “off-the- shelf” software, they must ensure that it will perform as intended in its chosen application.

FDA has amended the requirement to state, “When computers or automated data processing systems are used as part of production or the quality system,” for clarification. Software used in production or the quality system, whether it be in the designing, manufacturing, distributing, or tracing, must be validated.”[1]

According to FDA’s Francisco (Cisco) Vicenty, Program Manager, Case for Quality, FDA CDRH, the MedTech industry’s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risk to patients.  This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices.  Additionally this single-mindedness has led to low rates of investment in automation and digital technologies. Continue reading