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The product development and support team has teams have multiple sources of feedback to support continuous review of ClinSpark, some of which are listed below.
ClinSpark is typically updated multiple times in a year; continuously undergoing review and improvement.
Periodic Review
The review process for ClinSpark is continuous and includes multiple sources of feedback including incident level and other issues encountered by customers in their daily use of ClinSpark.
We may use inputs from:
trend Trend and summary data from the customer service desk
incident Incident reports and other issues (bugs, change requests etc.)
information Information on the uptime for production environments
information Information on the responsiveness for production environments
quality Quality assurance and regulatory inspection audit findings relevant to ClinSpark that customers are willing and able to share
internal Internal audit findings applicable to the operation of ClinSpark in production environments
evidence Evidence of attempted or actual security penetration attempts (in environments that we can monitor)
findings Findings from planned independent penetration testing
evidence Evidence of other attempted or actual attacks on ClinSpark environments (etc. DDoS)
information Information on significant changes in business requirements, legislation or best practice
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Issues impacting data quality and safety are prioritised.ClinSpark is typically updated three to four times a year (the goal is quarterly).
References
GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems, ISPE, 2008