With the ever-evolving advancements of computerised systems and their involvements in the pharmaceutical, medical device, biotechnology and clinical trial industries, it is more critical than ever to ensure that these systems are appropriately assessed, validated and controlled. This is essential to safeguard the ensuing data integrity, product...
Computer Software Assurance (CSA) Webinar for ISPE India
The International Society for Pharmaceutical Engineering (ISPE) is a global not-for-profit association serving its members involved across the entire pharmaceutical product lifecycle. Affiliates and Chapters of the ISPE can be found around the world.
ISPE India, the Indian affiliate of ISPE, recently invited SeerPharma's Director – Ian Lucas, to...
Webinar with ISPE India on Computer Software Assurance - 8 Oct 2021
The International Society for Pharmaceutical Engineering (ISPE) is a global not-for-profit association serving its members involved across the entire pharmaceutical product lifecycle. Affiliates and Chapters of the ISPE can be found around the world.
Computer Software Assurance - Configuration, Design & Closing the Loop
In the previous article, we looked at including Test Cases and the Functional Risk Assessment into the Functional Requirements Specification. This provided multiple benefits over maintaining these as separate documents:
- Forces requirements to be testable (described in the test cases)
- Forces thinking using ‘what if’ scenarios on requirements which...
Computer Software Assurance (CSA) - Use of Critical Thinking
In previous articles, we looked at reasons to rethink and simplify the approach to Computer System Validation (CSV). This highlighted a system level ‘macro risk’ assessment using several key factors (including GAMP category and direct/indirect product impact) to determine an overall Risk Profile Score; and then a GAMP functional risk assessment...
Computer Software Assurance (CSA) – Risk and Reward
In a previous article, we looked at the reasoning behind why the FDA thought there was a need for a change of approach for many companies with their Computer System Validation (CSV). In this article we will look at how a more structured risk assessment approach will lead to greater computerised system rewards – and at a lower cost.
Computer Software Assurance (CSA)
Computerised System Validation (CSV) is an activity carried out by Pharmaceutical and Medical Device organisations to ensure that IT infrastructure and applications that impact product quality are operating in a controlled state. Organisations must demonstrate an appropriate level of control of their Computer Systems to regulators such as the US...