APR January/February 2022 - 50

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MANUFACTURING
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if the organization has a mature supplier assessment process and
supplier management controls. Additionally, we could further
examine which IT controls are best performed by the service provider
(and potentially shift the controls from our regulated company to the
provider), as well as the current certification programs commonly
attained by providers. It is also beneficial if our partner has a strong
presence of the regulated companies as a cohesive block in the cloud
and there is a degree of flexibility and scaling possible. Only then
with this analysis and dialogue between cloud providers, regulated
companies and regulators can a framework be created that will satisfy
the regulated industry.
The bigger cloud service providers have an excellent track record of
uptime and business continuity, very few security incidents operating
with practices designed for a pure IT industry. There already is a wide
range of industries using these services, including highly regulated
industries such as the banking sector. In most cases the processes
sufficient for finance and good enough for large, regulated companies.
In the end, it is about trust and partnership but within a standardized
compliance framework. Partner with your IT department, enhance
your Supplier Assurance function, demand the certifications and
evidence of compliance but also contribute to the growth of Cloud
related companies and to those partnerships. Spread the regulatory
awareness within the IT industry, the need for quality, document and
record management, providing evidence related to each step of the
creation of the service or validated system/application support. This
layered approach can only work when cooperation is on the highest
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| January/February 2022
level, and we all need this, not only because we have to present a
coherent story to the FDA inspectors and external auditors.
References
1.
2.
3.
Available at: https://www.gartner.com/en/publications/2021-cio-agenda-seize-thisopportunity-for-digital-business-acceleration
Available
at: https://www.gartner.com/en/newsroom/press-releases/2021-11-10gartner-says-cloud-will-be-the-centerpiece-of-new-digital-experiences
Available
at: https://www.gartner.com/en/newsroom/press-releases/2020-11-17gartner-forecasts-worldwide-public-cloud-end-user-spending-to-grow-18-percentin-2021
4.
Available
at: https://ispe.org/pharmaceutical-engineering/january-february-2014/cloudcomputing-gxp-environment-promise-reality#
Author
Biography
Agata Mizera is creator of the Governance, Risk and Compliance
solutions for complex IT environments within highly regulated, pharma
environment. Experienced Quality and Security Consultant and auditor
with strong ISO 9001, ISO/IEC 20001, ISO/IEC 27001 and ISO 31000, risk
management, regulatory and Computer System Validation background.
Addressing the GRC challenges within a " cloud first " solution with a heavy
automation approach and a truly transformational journey and outcome
to meet the Client's objectives. 14 years of IT experience working within
regulatory-driven environment for multiple Clients across the world.

https://www.gartner.com/en/publications/2021-cio-agenda-seize-this-opportunity-for-digital-business-acceleration https://www.gartner.com/en/newsroom/press-releases/2021-11-10-gartner-says-cloud-will-be-the-centerpiece-of-new-digital-experiences https://www.gartner.com/en/newsroom/press-releases/2020-11-17-gartner-forecasts-worldwide-public-cloud-end-user-spending-to-grow-18-percent-in-2021 https://ispe.org/pharmaceutical-engineering/january-february-2014/cloud-computing-gxp-environment-promise-reality#

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022