We received several questions from our friends/customers, and one of the most favorite questions is “Why do we need Computerised System Validation (CSV) for BATCHLINE? and What is involved?”. There are many reasons why BatchLine needs to be validated, here are some of the answers to that question.
BatchLine shall be used to manage electronic records and electronic signatures that are GxP critical and used for regulatory purposes, and so the system should be subject to Computerised Systems Validation.
BatchLine is a standard qualified product that allows users to access to the application via an internet connection to a Cloud environment, under a Software as a Service (SaaS) subscription. The underlying infrastructure is provided by the Cloud Service Provider Microsoft™ upon their Azure™ platform (Platform as a Service). All standard requirements, specifications and functions are fully qualified and tested by BatchLine. However, in order to adopt BatchLine for use in a production environment there is some User specific configuration required and this is one reason why users need to validate the system.
As BatchLine is the supplier of a software service for GMP usage, they are responsible for the Qualification of the application prior to each versions’ release. The users are responsible for the Validation of their deployment.
BatchLine Development and Qualification
All the standard requirements, specifications and functions are tested and qualified in this phase. A qualification report is provided and includes a summary of qualification activities performed by the Supplier, and this document can be used as a basis for planning validation activities.
BatchLine Deployment to customer
The BatchLine software is considered as a standard off the shelf product GAMP Category 3. The User’s content (i.e. Batch Specs, users master data, material master data) are defined as a configuration of the application in order to meet specific requirements for the User’s manufacturing, and therefore the batch specifications and required data are classified as GAMP category 4 – Configurable. The underlying and supporting Cloud Platform is classified as a GAMP category 1 - Infrastructure.
During this phase, users shall determine an appropriate validation strategy and perform a risk assessment to identify the potential hazards and necessary mitigation control for adopting BatchLine for GxP critical processes. Each of the validation activities shall provide evidence that the User’s specific configuration of the system and supporting local infrastructure is fully specified, verified and controlled throughout of the system life cycle.
Preecha Khawsa-ard, Compliance Consultant
Why do we need to do CSV for Batchline and what is involved?