New BPIT guidance to align cloud services to regulatory requirements

New BPIT guidance to align cloud services to regulatory requirements

Cloud services are being increasingly used to provide a cost effective and flexible platform for software. As GxP systems increasingly move onto the cloud agreement is vital for both provider and customer responsibilities to maintain compliance. For example, how does the provider ensure the security of the underlying infrastructure? Does the provider utilize commercially available software products that are developed and tested to IT industry standards? And does the customer perform periodic reviews of their provider configurations and the systems they deploy? With a lack of clarity on questions such as these we open ourselves up to both risk and a lack of consistency across the industry.

In response to this set of uncertainties the BPIT Compliance team have developed and recently published a paper designed to create the clarity through a checklist of critical questions by control area. The group believe that this method will help companies gain all the benefits of hosting GxP systems in the cloud while providing the necessary level of regulatory compliance and assurance.

The paper has focused on infrastructure as a service and is vendor neutral. You can access the paper here

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

Newsletter subscribe

You can unsubscribe at any time by clicking the link in the footer of our emails. For information about our privacy practices, please visit our website.



© 2019 Biophorum Operations Group · All Rights Reserved

Registered Address: 5 Westbrook Court · 2 Sharrow Vale Road · Sheffield · S11 8YZ

Company Number 06794795 · VAT Number GB298617544

Driving progress in Cell & Gene Therapy

Now with 19 member companies and 183 subject matter experts, the BioPhorum Cell & Gene Therapy (C>) Phorum has made great strides since its formation[...]

Read More
Cell and Gene Therapy Phorum accelerates progress

The BioPhorum Cell & Gene Therapy Phorum has made significant progress since its creation in 2018 – from building networks and sharing knowledge to endorsing[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Sharing ideas on forced degradation

“Forced degradation studies are an important part of the drug lifecycle process as they can inform many aspects of drug development,” said Jennifer Halley, Principal[...]

Read More
The BioPhorum and USP collaborative journey to new standards

BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.

Read More
Perfecting balanced scorecards for CDMOs

Established in March 2017, the Development Group’s Development Outsourcing effort aims to share and build guidance that will help companies make the best decisions and[...]

Read More
How well can you handle SUS changes?  Take our surveys and see

BioPhorum delivery of value from the disposables five-year plan - supplier change notifications for single-use systems

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Why leaders should go to where work is performed to learn about success, failure and risk
Read More
Hi-tech ambitions for Fill Finish

The Fill Finish Phorum has recently embarked on a series of exciting and ambitious initiatives, exploring new technologies and processes to enhance the efficiency and[...]

Read More
Companies poised to follow ARMM recommendations

The Advanced and Rapid Microbial Methods (ARMM) team set out a clear case for modernizing Environmental Monitoring (EM) in grade A settings: in summary bio-fluorescent[...]

Read More
How to achieve the ‘Goldilocks’ amount of environmental monitoring

Regulators require a risk-based approach to environmental monitoring (EM)… but they give no clear definition of what “risk-based” actually means. The aim of the Environmental[...]

Read More
The ‘how to’ guide to implementing Agile in GxP

The publication of the Guidance on the use of Agile in a GxP Environment document in 2017 was well received.It described how the use of[...]

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Supply chain, forecasting and demand planning solutions gain momentum

The relationship between suppliers and manufacturers is one of the most crucial in biopharmaceutical manufacturing. This is especially the case when forecasting and supply planning.[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
BioPhorum and Rx-360 pilot a joint audit model for single-use systems

BioPhorum and Rx-360 have agreed a pilot to validate the use of the Joint Audit Model in the single-use systems supply chain.

Read More
Removing the roadblocks to continuous biomanufacturing

Continuous downstream processing is increasingly seen as a feasible approach for manufacturing biologics. The industry recognises that it offers advantages over batch-based processing by:

Read More
Changing mindsets with a modular approach

Historically, manufacturers have used a ‘waterfall’ approach when designing and building their production facilities, sequentially resolving and specifying all aspects up front and in detail[...]

Read More
How do you bring technology roadmapping to life?

You use it to make change happen and that is exactly what the Phorum’s leaders did after the first edition of the Biomanufacturing Technology Roadmaps[...]

Read More
Slicing years off change implementation

As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (Anvisa)[...]

Read More
BioPhorum Regulatory Interaction: helping to open doors

To implement any change in the biopharmaceutical manufacturing industry it is important to engage with and collaborate with the regulators. Set up two years ago,[...]

Read More
A new way to navigate the regulatory maze of medical technology

How do you prefer to face a challenge? Fly solo or work with a team of like-minded experts? The MedTech Phorum is a new collaboration[...]

Read More
Navigating the maze of medical technology regulation: a solo voyage or a team effort?

Medical technology is a global business, generating annual revenues of over $400bn. The sector encompasses a broad range of technologies: from in-vitro diagnostics and diagnostic[...]

Read More

IaaS Cloud webinar recording play back
Read More
New BPIT guidance to align cloud services to regulatory requirements
Read More
Data Integrity and Agile Webinars to support industry response to regulators
Read More
How to validate informatics in CPV programs

The BioPhorum Continued Process Verification (CPV) and Informatics team has published a paper to support a risk-based approach for the validation of informatics systems for[...]

Read More
Continued Process Verification delivering real saving in time and money

More than 50 per cent of biopharma products on the market now have Continued Process Verification (CPV) plans in place.  Thanks to the CPV white[...]

Read More
A roadmap for the implementation of continued process verification

This article provides a roadmap draws on the content of the CPV case study to provide a step-by-step guide in a more accessible form.

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
Digital plant maturity model webinar replay
Read More
Digital Plant Maturity Model workstream to host webinar
Read More
New guidance available on Forecasting and Demand Planning to streamline supply chain performance
Read More
Host cell proteins poster

This poster presented at the BEBPA Conference, San Francisco builds and consolidates the information currently available in the industry for assessing process risk from Host[...]

Read More
Host cell protein risk assessment, an industry approach

Host cell protein (HCP) constitutes a significant class of process-related impurities in biological drugs.

Read More
BEBPA risk assessment workshop
Read More