KENX is a leading knowledge exchange network in the life sciences industry, at the forefront of coordinating and running events focused on making pharmaceuticals and devices safer. The organisation achieves this by bringing together regulators and industry leaders to address the latest industry trends, regulatory changes, business challenges and...
The Singaporean division of a global diagnostics equipment manufacturer engaged SeerPharma to deliver training on Computer Software Assurance/Validation and 21 CFR Part 11. Multiple workshops were delivered to over 50 staff, to help them appreciate the regulatory expectations of the US FDA , for the work performed on-site.
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...
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.
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:
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.
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...
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