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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...

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...

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.

The stages required for applying ISO 14971 principles to risk management for medical devices can be typically broken into 6 steps:

Quality Risk Management (QRM) is a GMP compliance requirement for Pharmaceutical organisations. The ICH Q9 guideline on Quality Risk Management (Annex 20 of the PIC/S GMP Guide) is expected to be adopted by manufacturers to ensure compliance with clauses 1.12 and 1.13 of Part I of the PIC/S GMP Guide:

As part of our commitment to the local biotech sector, SeerPharma was proud to sponsor a BioMelbourne Network session on Corporate Culture and Risk earlier this year.

A biopharmaceutical manufacturer engaged SeerPharma to provide on-going coaching to their Quality personnel and advise on improvements to help prepare for a FDA inspection.

We invite you to attend our inaugural SeerPharma Symposium, which will be held at the Park Hyatt, in Melbourne on Friday the 20th of May.

After 25 years of serving pharmaceutical and medical device professionals in the Asia-Pacific region, we would like bring all of you under the one roof. With this in mind, we’d like the day to focus on “How you...