Life science industries generally face several challenges in adopting to the technological advances considering the regulatory impacts and tedious processes involved. But with the alluring benefits provided by cloud based solutions and the need to globalize R&D, moving to cloud has become the “New Normal”. Though adoption of cloud might reduce the effort of the R&D personnel in maintaining and administering the services, it does not spare them from their ultimate responsibility to ensure that the applications in cloud are validated and comply with the regulations. Validation of applications is complete only with the qualification of underlying infrastructure.

Wondering how to formulate an approach to qualify cloud infrastructure? Here it is:

Vendor Assessment:

  • To assess their capability to deliver the as per your requirements
  • Assess different regulatory requirements and standards to be followed and check compliance to them has been achieved.
  • Presence of quality management system and procedural controls to ensure confidentiality, integrity and availability.


Determine Qualification Scope and Infrastructure Layer

  • List down all the infrastructure components from the inventory record.
  • Identify those having an impact on regulatory and business operations at your organization.
  • Identify the infrastructure layer to which each component belongs.


Perform Risk Assessment

  • In a risk based approach, upon determining the scope, a documented risk assessment must be conducted to analyze the impact on intended use, regulatory compliance and business continuity
  • The likelihood of occurrence and probability to detect must also be considered
  • Qualification activities will be tailored to minimize these risks


Qualification Deliverables

The qualification deliverables required in general include the following:

  • Risk Assessment Report
  • Qualification Plan
  • Requirement and Design Specification
  • Qualification Protocol
  • Traceability Matrix
  • Qualification Summary Results


Plan Qualification Activities and level of qualification

Based on the components in scope , the results of the risk assessment, reliability of the supplier, a qualification plan must be formulated detailing the level of qualification required followed by the creation of qualification deliverables.


Qualify any Cloud Infrastructure solution of your choice, with the help of our checklist here!