“The validation of any cloud based application involves additional considerations and risks that must be taken into account during the planning process. Any life science company looking to validate cloud based systems must adjust its system qualification process to properly prove to any auditor that the application in question is installed, operating correctly while also meeting the users requirements.”

Previous posts have provided a generic overview of what it takes to validate applications to meet FDA 21 CFR Part 11 guidelines. These guidelines are put forth by the FDA and apply to any system maintaining electronic records dealing with the research, testing, manufacturing and distribution of a medical device or drug.

I mentioned in a prior post three of the components that are part of the Part 11 validation process, the Installation Qualification (IQ), the Operational Qualification (OQ) and the Performance Qualification (PQ). There are several other critical documents that make up the overall validation package that would be reviewed by the FDA, they include:

- Validation plan: the document that describes the software validation strategy, scope, execution process, roles,  responsibilities, and general acceptance criteria for each system being validated

-  Functional Requirements: these are based on the user requirements and define the processes and activities to be supported by the system

-  Traceability Matrix: used to cross reference the functional requirements to actual validation test scripts to ensure that all user requirements are tested and have been proven to be fulfilled

-  Installation Qualification: a set of test scripts that provide verification that the hardware and software are properly installed in the environment of intended operation

-  Operational Qualification: verification that hardware and software are capable of consistently operating as expected and originally predicted

-  Performance Qualification: proving that hardware and software can consistently perform within pre-defined or particular specifications and also meet the requirements as defined

-  Validation Summary Report: a report summarizes the validation activities and results and provides the approving individuals with the software recommendation of acceptable or unacceptable for use

Every life science company must have SOP’s that spell out the validation process, roles, responsibilities, and what must be covered in the actual validation package itself. On top of that would be a number of associated procedures that provide additional guidance on such topics as change control, documentation practices, auditing, access controls and development methodologies. There can also be a validation master plan that describes what systems need to be validated within the company, for example a companies HR system may not need to be validated, and can provide templates and additional details on how the validation process must occur.

As you can see there is an entire eco-system of procedures, templates, and documents that make up the Part 11 validation process within any company that must adhere to FDA regulatory guidelines. For many large scale deployments the validation process can take nearly as much time and effort as the actual system implementation itself. The question is how does the advent of cloud computing impact all of these processes and protocols? What additional items will the validation process need to take into account when attempting to validate cloud based applications? I will provide some basic information below and then add more detail in a future blog entry.

- Validation Master Plan: the VMP will need to spell out what will or will not need to be added to the validation process due to the use of cloud computing. This includes all three facets of cloud (IaaS, PaaS, and SaaS). This can include such things as performing on-site audits, obtaining vendor employee training records, and auditing vendor change control, software development processes and security access procedures

- System Validation Plan: this will depend on what  aspect of cloud is being used in the system, for internal applications being run on IaaS then the validation plan will need to address the additional requirements on validating the infrastructure, if PaaS is being leveraged the validation plan will need to prove the installation and operations of the PaaS environment and similarly for SaaS, the plan will need to define the validation process for an externally provisioned application

- Functional Requirements: there may need to be additional functional requirements as part of the cloud validation process for security, access, encryption, latency and response times

- Installation Qualification: as described in the validation plan, the type of cloud services being utilized will have a significant impact on what must be validated, for IaaS whether it is public or private cloud can be a big difference, for PaaS the validation of the supporting infrastructure can be provided by the vendor and evaluated for inclusion in the overall package. For SaaS it would be relatively the same

- Operational Qualification: once again depending on the type of cloud services being used the OQ, additional testing will need to address the operational effectiveness of the environment and take into account any changes required to qualify the cloud environment

- Performance Qualification: the PQ may incorporate additional scripts to prove that the system is meeting its defined user requirements, other test scripts may be necessary to prove such things as response times, security, or backup/recovery of cloud based applications

- Validation Summary Report: the thrust of the summary report will not change as its purpose is to collate all of the information generated during the validation process and to ensure that it is properly collated and can support the recommendation that the system meets its initial specifications/requirements and it ready to use

By taking into account the validation process changes required to support cloud applications, life science companies can provide the proper levels of assurance to the FDA that their applications running in the cloud meet the necessary Part 11 guidelines.