Computer System Validation (CSV) of BatchLine

In the previous article, “Why do we need to do CSV for Batchline and what is involved?“, we covered some of the High-level considerations for a customer validating BatchLine. This article focusses more on the validation deliverables and activities. The BatchLine validation deliverables may include the following.

• Validation Plan (VP) and High Level Risk Assessment (HLRA):  
  A Validation Plan defining the customer’s tasks, roles, and responsibilities to ensure that the User-specific configuration of BatchLine is compliant and fit for its intended use. A High-Level Risk Assessment assesses the risks for the customer adopting BatchLine SaaS for GxP critical processes.

• User Requirement Specification (URS):
  The URS defines what the user requires the application to do, including any critical GxP aspects, and includes a business process workflow. BatchLine provide a standard URS for the application, so any customer specific requirements may be added as a document addendum if necessary.

• Process and Risk Assessment (PRA):
  A Process and Risk Assessment (PRA) is conducted following a business process and data workflow to analyse risks and mitigation actions. The risks and mitigation actions shall form the basis for test planning during verification stages or be used as the basis to enhance procedural controls covered by SOPs.

• Infrastructure Design and Configuration Specification (ID&CS): 
  An Infrastructure Design and Configuration Specification (ID&CS) defines the customer’s local infrastructure specifications required to access BatchLine (including hardware, software, and networking) and the customer specific application configuration.

• Infrastructure and Configuration Acceptance Test (ID&CAT) Specification and Report:
  To verify and document the customer’s infrastructure and configuration according to the ID&CS.

• User Acceptance Test (UAT) Plan, Specification, and Report:
  The UAT Plan and Specifications consider the outcome of the HLRA and PRA to design the test cases. The UAT confirms that the BatchLine configuration is working and effective in the context of the user’s process.  

• Standard Operating Procedures (SOPs): 
  To maintain the validated status of the system throughout its operational usage, a set of SOPs are prepared, reviewed, and approved prior to the system’s release and users are trained on the SOPs. The list of required SOPs is based on the results of the HLRA and PRA.

• User Training:
  Users are trained on BatchLine and the supporting SOPs that are required to maintain the integrity of the data and the system.  

• Validation Report (VR): 
  This document provides a summary of all the completed validation activities and documents and includes a statement to declare that the application is compliant and fit for its intended use in the production environment.