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What Needs to be Validated?

The term validation has a very specific and stringent definition as far as pharmaceutical, medical device and biotech companies are concerned.  At a high-level, the concept of validation ensures a system is operating as intended.  More specific to life sciences companies, validation is a structured process to satisfy a regulatory requirement. Validation deliverables should be considered living documents that provide reliability and assurance that a specific process, method, or system will produce a result that meets a given standard or acceptance criteria.  The thinking behind this approach is to have systems that manufacture, control inventory, or have an impact of the quality of the product, demonstrate that processes are under tight control.  As a result, training records, change control, complaint handling, or anything that may have an affect on cGxP functions (GMP, GCLP, GLP) would fall under the scope of validation.

As life sciences companies rely heavily on software to produce products, common examples of information systems that are typically in the realm of validation are below:

  • ERP (Enterprise Resource Planning)
  • MES (Manufacturing Execution System)
  • PLM (Product Lifecycle Management)
  • CRM (Customer Relationship management)
  • LIMS (Laboratory Information Management System)
  • LMS (Learning Management System)

Also, life sciences companies have are diverse in that the use of software varies.  It is possible that 3rd party providers also fall under the scope of validation, to possibly include:

  • SaaS (Software as a Service)
  • IaaS (Infrastructure as a Service) 
  • Data Centers

The question of what needs to be validated is hardly concrete.  A comprehensive functional assessment should be performed for all processes that may affect the quality of the product, whether on the manufacturing floor or in the lab.  A regulatory grade functional assessment is the first step and should contain critical rationale into identifying GxP systems.  This step should be taken with expertise and care, as it serves the foundation for auditable documentation.

Posted By: Derek Jager, Validation Analyst