Validation of Public Cloud Infrastructure: Satisfying FDA Requirements While Balancing Risk Vs. Reward

By Bruce Maches

August 3, 2010

In a prior post I provided an overview of the 21 CFR Part 11 validation guidelines and the impact of these requirements on the validation of public cloud infrastructure services. The main thrust of that post was discussing how current industry validation practices are a potential impediment to the full-scale adoption of cloud computing in the life sciences. Especially in regards to the use of public cloud infrastructure related services for applications coming under Part 11 guidelines. See my May 5th post for additional background. I have received some feedback on potential approaches to validating public cloud based applications and thought I would provide some additional thoughts here.

The key word here is trust – if I am an FDA auditor how do I know I can trust the installation, operation and output of a particular system? The actual Part 11 compliance process for any application includes the hardware, software, operational environment and support processes for the system itself. This allows an IT group to answer the questions:

Can I prove the entire system (hardware, software) was installed correctly?

Can I prove the system is operating correctly?

Can I prove the system is performing correctly to meet the user requirements as stated in the Design Qualification documents?

Can I prove that the system environment is properly maintained by people with the requisite skills and that all changes are being properly documented?

The validation of public cloud offerings revolves primarily around the first and last question above. How do I ensure that the overall environment was designed, implemented and maintained per Part 11 guidelines? If a life science company wanted to leverage public cloud computing for validated applications it would have to take a hard look at the risks vs. rewards and develop a strategy for managing those risks while ensuring that the advantages of leveraging public cloud could can still be realized.

There are several steps a company can take to start down this path. The initial step would be to develop an internal strategy and supporting processes for how the organization is planning to meet Installation and Operational Qualification (IQ & OQ) portions of the Part 11 guidelines in a cloud environment. The strategy would be incorporated into the overall Validation Master Plan (VMP). This plan is the first stop for any auditor as it spells out the organizations overall validation strategy as to what systems will require validation and how that will be performed. For validating public cloud the VMP would need to address at a minimum such topics as:

– The actual hardware (IQ) piece, since a server serial number is not available what documentation of the system physical and operating environment is acceptable?

– What level of data center (i.e. SAS 70 Level II) is approved for use by the organization for public cloud applications and how is that certification proven?

– What documentation can the cloud vendor provide describing how they developed and implemented the data center environment?

– What training and certification documents are available for the vendor personnel who will be managing/maintaining the environment?

– How detailed and accurate are the vendors change management records and processes?

Any organization creating this type of a strategy would have to assess its appetite for potential risk and balance that against the gains and cost savings that are a part of the promise of cloud computing. There are no hard and fast rules on how this can be done as every organization is unique.

Another piece of the puzzle is with the OS and associated software being deployed. This portion of the environment can be easily validated with a documented IQ and a pre-qualified image built. This image can then be loaded up into the cloud as needed and used over and over again. A company can build a whole library of the pre-validated images and have them available for quick deployment which drastically cuts down the time it takes to bring a new environment on-line. There are a number of vendors who are building these pre-qualified images that provide choices in the OS (Windows, Linux) databases, and other portions of the software environment.

As I have mentioned in several prior posts the possibilities for leveraging cloud computing in the life sciences are potentially enormous. From speeding up drug research and discovery, allowing for the rapid deployment of new systems, providing the needed compute power required by resource hungry scientific applications, to cutting costs and migrating legacy applications into the cloud there are a myriad of ways that life science CIO’s can leverage cloud environments, both public and private. As with any change, part of the CIO’s responsibility is to make sure that the organization has a clear and well thought out strategy for incorporating cloud computing into its overall IT strategic direction
 

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