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Digital strategy in pharma: GAMP Francophone position paper on CSA

Digital strategy in pharma:
GAMP Francophone position paper on CSA

GAMP Francophone Position paper on CSA – Computer Software Assurance

In light of the COVID-19 pandemic, too low levels of adopting a digital strategy in the pharmaceutical industry and the prevalence of paper-based processes in the validation of applications and processes , GAMP Francophone, has published a position paper on US-FDA’s initiative on CSA – Computer Software Assurance. The CSA is a prioritized guidance document, intended to be published in FY2021by the FDA. The new guidance is intended to shift the focus of the document-oriented computer validation towards a risk-based, critical thinking approach.

The position paper observes that the practices in the healthcare industry “show a certain difficulty, or even inability, to take advantage of technological developments and alternative project management approaches”

The paper stresses the importance of not immobilizing the technical and digital evolution while waiting for FDA’s new guidance document on CSA– but meticulously plan for the anticipated progress and take the opportunity to invest in the understanding of new technologies. It also underlines that the current European regulatory framework “through its systematic consideration of quality risk management”, currently do provide generous amplitude for implementing new and innovative approaches and that GAMP5 in a similar manner encourages creativity and efficiency in their industry practices.

As a company developing digitized compliance solutions to the pharmaceutical industry which will be validated, we are certainly looking forward to the published guidelines.

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Featured in Thinkbusiness.ie

Bonafi Featured in Thinkbusiness.ie

Glad to be the Editor’s Pick in this morning’s Business Planning section of Thinkbusiness.ie.

You can find a link to the article on the right.

 

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Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

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Interview with DublinBIC

Talk with Dublin BIC

I was invited by Dublin BIC to talk about Bonafi, patient safety, and falsified medicines. Our conversation sheds light on why it is important to know who your pharma customers and suppliers are, and how patients could be put at risk if the due diligence is not carried out.  We also discussed the potential risks that have emerged as a result of COVID-19. 

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FIND US

Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

GET IN TOUCH

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Seedcorn Competition

Regional Finalist in the Seedcorn Competition!

Really glad to announce that Bonafi is one of the regional finalists for Dublin as a start-up in the biggest business competition across Ireland and Northern Ireland for an innovative new start and early-stage businesses in any sector.

Bonafi will go on to compete in the Seedcorn Final and the winner is announced on the 26th November. Stay tuned and wish us good luck!

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FIND US

Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

GET IN TOUCH