Penetrating the Cloud

IVT's Conference on Cloud and Virtualization (Dublin, 13-14th November 2012) was everything I'd hoped it would be. After two year of conference sessions simply peering into the Cloud to understand what it us, or sticking a head in to the Cloud to see what the risks are, it was good to spend two days looking through the Cloud to see how these risks can be managed and to review some case studies.

It served to endorse our opinion that while generalist Cloud providers are either not interested in the needs of the Life Sciences industry, or are still struggling to understand Life Sciences requirements, what some people have called the 'Pharma Cloud' (or 'Life Sciences' Cloud, and what we define as Compliant Cloud Computing) is here. As we report in one of our latest Perspectives opinion pieces, while specialist providers are relatively few, Infrastructure, Platform and Software as a Service can now be provisioned in a manner that meets the expectations of most regulators.

While it would have been good for an organization such as ISPE to provide such clarity, well done to IVT for organizing events in the US and Europe and giving people a chance to unpack such issues. To be fair to ISPE, many GAMP sessions have looked at Cloud at country specific meetings and conferences, but the topic really does need a couple of days to get your head around.

What also emerged was the ability to select the right Cloud model, including On-Premise options and discussions with a number of delegates confirmed the attractiveness of the Compliant Cloud Anywhere solution (IaaS, installed On-Premise, but owned and operated by a specialist Cloud Services provider).

At the end of the IVT event delegates (many of whom are from QA or IT Quality) went home with a much better understanding of what Cloud and Virtualization is and what the risks are. Perhaps more importantly, what also emerged were some good examples of how to mitigate the risks and the outline of a strategy to move further into the Cloud without risking regulatory compliance.

As we'll explore in our webcast "State of the Art in Compliant Cloud Computing", relatively few Life Sciences companies have a real Cloud Strategy that also addresses regulatory compliance and this is quickly becoming a necessity for organizations looking the take advantage of the business benefits that Cloud and Virtualization offers.

As clarity emerges we expect to see things move significantly further into the Cloud in the next 12 months - "watch this space" as they say!

Validating Clouded Enterprise Systems - Your Questions Answered

Thank you once again to those of you who attended the latest stage on our virtual book tour, with the latest stop looking at the validation of enterprise systems in the Cloud. This is in relation to chapter 17 of "Validating Enterprise Systems: A Practical Guide".

Unfortunate we had a few technical gremlins last Wednesday (both David Hawley and myself independently lost Internet access at our end just before the webcast was due to start) and so the event was postponed until Friday. Our apologies again for that, but we nevertheless received quite a number of registration questions which were answered during the event (you can find a recording of the webcast and copies of the slides here).

We did manage to get through the questions that were asked live during the webcast but we received one by e-mail just after the event which we thought we would answer here in the blog.

Q. "What elements should go into a Master VP for Clouded application / platforms?

A. It depends on the context that the phrase Master Validation Plan is being used. In some organisations a Master Validation Plan is used to define the approach to validating computerised systems on an individual site, in an individual business unit or, as will be the case here, for applications in the Cloud.

In other organisations a Master Validation Plan is used to define the common validation approach which is applied to an enterprise system which is being rolled out in multiple phases to multiple sites (each phase of the roll-out would typically have a separate Validation Plan defining what is different about the specific phase in the roll-out)

Logically, if we are implementing a Clouded enterprise application it could (and often would) be made available to all locations at virtually the same time. This is because there is limited configuration flexibility with a Software-as-a-Service solution and different sites have limited opportunities for significant functional differentiation. In this context is it is unlikely that the second use of a Master Validation Plan would be particularly useful so we'll answer the question in the first context.

Where a Master Validation Plan is being used to define the approach to validating Clouded enterprise systems it need to define the minimum requirements for validating clouded applications and provide a framework which:

• Recognises the various cloud computing models (i.e. Infrastructure-as-a-Service, Platform-As-a-Service, Software-as-a-Service; Private Cloud, Community Cloud, Public Cloud and Hybrid Cloud; On-Premise and Off-Premise
• Categorises platforms and applications by relative risk and identifies which cloud models are acceptable for each category of platform/application, which models are unacceptable and which ones may be acceptable with futher risk controls being put in place
• Identifies opportunities for leveraging provider (supplier) activities in support of the regulated company's validation (per GAMP 5/ASTM E2500)
• Stresses the importance of rigourous provider (supplier) assessments, including thorough pre-contract and surveillance audits
• Highlights the need to include additional risk scenarios as part of a defined risk management process (this should include risks which are specific to the Essential Characteristics of Cloud Computing as well as general risks with the outsourcing of IT services)
• Lists additional risk scenarios which may need to be considered, depending upon the Cloud Computing model being looked at (these are discussed in our various webcasts)
• Identifies alternative approaches to validating clouded enterprise systems. This would most usefully identify how the use of Cloud computing often prevents traditional approaches to computer systems validation from being followed and identifies alternative approaches to verifying that the Software-as-a-Service application fulfils the regulated companies requirements

With respect to the last point our webcast "Compliant Cloud Computing - Applications and Software as a Service" discusses issues with the validation of Software-as-a-Service applications using traditional approaches and outlines alternative verification techniques that can be used.

Whether it is in a Master Validation Plan or some form of Cloud strategy document, it is important for all regulated companies to start to think about how they will validate Clouded applications. This is clearly a topic that is not going to go away and is something that all life sciences companies will need to address.

You may also be interested to know that on 15th November 2012 we're going to be looking more closely at the current state of the Cloud computing market specifically with respect to meeting the need of regulated companies in the life sciences industry .  We'll be talking about where the market has matured and where appropriate providers can be leveraged - and where it hasn't yet matured. Registration is, as ever, free of charge and you can register for the event at the Business & Decision Life Sciences website.

We look forward to hearing from you on the last stage of our virtual book tour when we'll be looking at the retrospective validation of enterprise systems, which we know is a topic of great interest to many of our clients in Asia, Eastern Europe, the Middle East and Africa and in Latin and South America.

Cloud Computing Comes of Age in Life Sciences

For a while now we have been saying the Cloud was coming of age in the Life Sciences industry.

Business & Decision,  along with a small number of other Providers have been providing Infrastructure-as-a-Service and Platform-as-a-Service for some time.

We also said that as far as Software-as-a-Service was concerned, we would see Life Sciences specialist vendors (e.g. LIMS, Quality Management, Learning Management etc) providing compliant Software-as-a-Service solutions - simply because they understand our industry both at the functional level and also at the regulatory level.

We are working with a number of such vendors to deploy their software on our Platform-as-a-Service solutions, leveraging virtualization to provision solutions that are inherently flexible, scalable and - perhaps just as importantly - compliant.

At the same time, we have just started to engineer our first compliant 'Cloud Anywhere' solutions - which allow us to deploy pre-engineered and pre-qualified Platforms (hardware, power, HVAC, storage, virtualization, operating systems, database servers and applications servers) anywhere in the world. This was an idea first developed with Oracle with their Exadata and Exalogic machines (for which Business & Decision developed standard Qualification Packs).

Based upon a wider and more affordable technology base ‘Cloud Anywhere’ allows Business & Decision to leverage our investment in our Quality Management System to provision compliant Private or Community Cloud solutions with the minimum of additional qualification activities. These can be installed on client sites, in third party data centres of in the data centres of our software partners.

As well as deploying the solution, these 'Cloud Anywhere' solutions also come complete with Managed Services from Business & Decision - meaning that clients, partners etc no longer need to worry about the management of the Platform. All of this is taken care of remotely by our own staff (with the exception of local power and network connections of course) and the solutions can also be engineered to automatically failover to a remote Disaster Recovery site.

In the last couple of years we have seen people asking "How long will it be before everything is in the Cloud?", but the reality is that this will never be case in Life Sciences. There will always be Life Sciences companies who need or want some infrastructure on their own sites (because of network latency issues or data integrity issues) and the reality is that we are moving towards a mixed-Model Cloud Environment.

We will see a mixture of non-clouded Infrastructure, Platforms and Software, and various Cloud models, including On-Premise & Off-Premise and Public & Private Clouds.

The coming of age of safe, secure multi-tenanted Software-as-a-Service and the availability of solutions such as 'Cloud Anywhere' means that Life Sciences companies now have the ability to mix'n'match their Cloud environments to meet their specific business needs - and address their regulatory compliance requirements.

It may not seem like it now, but in the next few years we will see these solutions move from leading-edge to mainstream and we will wonder what all the fuss about Cloud was for.

Computer System Validation Policy on Software-as-a-Service (SaaS)

In a recent LinkedIn Group discussion (Computerized Systems Validation Group: Discussion "Validation of Cloud), the topic of Software-as-a-Service (SaaS) was widely discussed and the need to identify appropriate controls in Computer System Validation (CSV) policies was discussed.

The reality is that relatively few compliant, validated SaaS solutions are out there, and relatively few Life Sciences companies have CSV policies that address this. 

However, there are a few CSV policies that I’ve worked on that address this and although client confidentiality means that I can’t share the documents, I did volunteer to publish some content on what could be included in a CSV policy to address SaaS.

Based on the assumption that any CSV policy leveraging a risk-based approach needs to provide a flexible framework which is instantiated on a project specific basis in the Validation (Master) Plan, I've provided some notes below (in italics) which may be useful in providing policy guidance. These would need to be incorporated in a CSV Policy using appropriate language (some Regulated Company's CSV Policy's are more prescriptive that others and the language should reflect this).

"When the use of Software-as-a-Service (SaaS) is considered, additional risks should be identified and accounted for in the risk assessment and in the development of the Validation Plan computer system validation approach. These are in addition to the issues that need to be considered with any third party service provider (e.g. general hosting and managed services). These include:

• How much control the Regulated Company has over the configuration of the application, to meet their specific regulatory or business needs (by definition, SaaS applications provide the Regulated Company (Consumer) with little or no control over the application configuration)

o   How does the Provider communicate application changes to the Regulated Company, where the Regulated Company has no direct control of the application?

o   What if Provider controlled changes mean that the application no longer complies with regulatory requirements?

• The ability/willingness (or otherwise) of the Provider to support compliance audits

• As part of the validation process, whether or not the Regulated Company can effectively test or otherwise verify that their regulatory requirements have been fulfilled

o   Does the Provider provide a separate Test/QA/Validation Instance?

o   Whether it is practical to test in the Production instance prior to Production use (can such test records be clearly differentiated from production records, by time or unique identification)

o   Can the functioning of the SaaS application be verified against User Requirements as part of the vendor/package selection process? (prior to contract - applicable to higher risk applications)

o   Can the functioning of the SaaS application be verified against User Requirements once in production use? (after the control - may be acceptable for lower risk applications)

• Whether or not the Provider applies applications changes directly to the Production instance, or whether they are tested in a separate Test/QA Instance

• Security and data integrity risks associated with the use of a multi-tenanted SaaS application (i.e. one that is also used by other users of the system), including

o   Whether or not different companies data is contained in the same database, or the same database tables

o   The security controls that are implemented within the SaaS application and/or database, to ensure that companies cannot read/write delete other companies data

• Where appropriate, whether or not copies of only the Regulated Companies data can be provided to regulatory authorities, in accordance with regulatory requirements (e.g. 21CFR Part 11)

• Where appropriate, whether or not the Regulated Companies data can be archived

• If it is likely that the SaaS application is de-clouded (brought in-house or moved to another Provider)

o   Can the Regulated Companies data be extracted from the SaaS application?

o   Can the Regulated Companies data be deleted in the original SaaS application?

If these issues cannot be adequately addressed (and risks mitigated), alternative options may be considered. These may include:

• Acquiring similar software from an acceptable SaaS Provider,
• Provisioning the same software as a Private Cloud, single tenancy application (if allowed by the Provider)
• Managing a similar application (under the direct control of the Regulated Company), deployed on a Platform-as-a-Service (PaaS)"

Hopefully these ideas will help people to develop their approach to SaaS, but CSV Policies should also address the use of PaaS and IaaS within the broader context of outsourcing.

Software as a Service - Questions Answered

As we expected, last week's webcast on Software as a Service (Compliant Cloud Computing - Applications and SaaS) garnered a good deal of interest with some great questions and some interesting votes.


Unfortunately we ran out of time before we could answer all of your questions. We did manage to get around to answering the following questions (see webcast for answers)

• Would you agree that we may have to really escrow applications with third parties in order to be able to retrieve data throughout data retention periods?
• How is security managed with a SaaS provider? Do they have to have Admin access, which allows them access to our data?
• How do you recommend the Change Management (control) of the SaaS software be managed?
• How can we use Cloud but still have real control over our applications?
• What should we do if procurement and IT have already outsourced to a Saas provider, but we haven't done an audit?

As promised, we have answered the two remaining questions we didn't get time to address below.

 

Cloud computing is, not surprisingly, the big topic of interest in the IT industry and much of business in general. Cloud will change the IT and business models in many companies and Life Sciences is no different in that respect.

 

We've have covered this extensively during the last few months, leveraging heavily on the draft NIST Definition of Cloud Computing which is starting to be the de-facto standard for talking about the Cloud - regardless of Cloud Service Providers constantly inventing their own terminology and services!

If you missed any of the previous webcasts they were
- Qualifying the Cloud: Fact or Fiction?
- Leveraging Infrastructure as a Service
- Leveraging Platform as a Service


There are of course specific issues that we need to address in Life Sciences and our work as part of the Stevens Institute of Technology Cloud Computing Consortium is helping to define good governance models for Cloud Computing. These can be leveraged by Regulated Companies in the Life Sciences industry, but it is still important to address the questions and issues covered in our Cloud webcasts.

As we described in our last session, Software as a Service isn't for everyone and although it is the model that many would like to adopt, there are very few SaaS solutions that allow Regulated Companies to maintain compliance of their GxP applications 'out-of-the-box'. This is starting to change, but for now we're putting our money (literally - investment on our qualified data center) into Platform as a Service, which be believe offers the best solution for companies looking to leverage the advantage of Cloud Computing with the necessary control over their GxP applications.

But on to those SaaS questions we didn't get around to last week:

Q. Are you aware of any compliant ERP solutions available as SaaS?

A. We're not. We work with a number of major ERP vendors who are developing Cloud solutions, but their applications aren't yet truly multi-tenanted (see SaaS webcast for issues). Other Providers do offer true multi-tenanted ERP solutions but they are not aimed specifically for Life Sciences. We're currently working with Regulated Company clients and their SaaS Cloud Service Providers to address a number of issues around infrastructure qualification, training of staff, testing of software releases etc, . Things are getting better for a number of Providers, but we're not aware of anyone who yet meets the regulatory needs of Life Sciences as a standard part of the service.

The issue is that this would add costs and this isn't the model that most SaaS vendors are looking for. It's an increasingly competitive market and it's cost sensitive. This is why we believe that niche Life Sciences vendors (e.g. LIMS, EDMS vendors) will get their first, when they combine their existing knowledge of Life Sciences with true multi-tenanted versions of their applications (and of course, deliver the Essential Characteristics of Cloud Computing - see webcasts)

Q. You clearly don't think that SaaS is yet applicable for high risk applications? What about low risk applications?

 

A. Risk severity of the application is one dimension of the risk calculation. The other is risk likelihood where you are so dependent on your Cloud Services Provider. If you select a good Provider with good general controls (a well designed SaaS application, good physical and logical security, mature support and maintenance process) then it should be possible to balance the risks and look at SaaS, certainly for lower risk applications.

 

It still doesn't mean that as a Regulated Company you won't have additional costs to add to the costs of the service. You need to align processes and provide on-going oversight and you should expect that this will add to the cost and slow down the provisioning. However, it should be possible to move lower risk applications into the Cloud as SaaS, assuming that you go in with your eyes open and realistic expectations of what is required and what is available.

 

Q. What strategy should we adopt to the Cloud, as a small-medium Life Sciences company?

 

A. This is something we're helping companies with and although every organization is different, our approach is generally

• Brief everyone on the advantages of Cloud, what the regulatory expectations are and what to expect. 'Everyone' means IT, Procurement, Finance, the business (Process Owners) and of course Quality.
• Use your system inventory to identify potential applications for Clouding (you do have one, don't you?). Look at which services and applications are suitable for Clouding (using the IaaS, PaaS and SaaS, Private/Public/Community models) and decide how far you want to go. For some organizations IaaS/PaaS is enough to start with, but for other organizations there will be a desire to move to SaaS. Don't forget to think about new services and applications that may be coming along in foreseeable timescales.
• If you are looking at SaaS, start with lower risk applications, get your toe in the water and gradually move higher risk applications into the Cloud as your experience (and confidence) grows - this could take years and remember that experience with one SaaS Provider does not automatically transfer to another Provider.
• Look to leverage one or two Providers for IaaS and PaaS - the economies of scale are useful, but it's good to share the work/risk.
• Carefully assess all Providers (our webcasts will show you what to look for) and don't be tempted to cut audits short. It is time well worth investing and provides significant ROI.
• Only sign contracts when important compliance issues have been addressed, or are included as part of the contractual requirements. That way there won't be any cost surprises later on.
• Remember to consider un-Clouding. We've talked about this in our webcasts but one day you may want to switch Provider of move some services or applications out of the Cloud.

The Cloud is coming - in fact, it's already here. As usual, were not always the earliest adopters in Life Sciences, but you need to be prepared to move and take advantage. We hope that our webcasts have helped - please do let us know if you have any questions.

E-mail us at life.sciences@businessdecision.com