Validating pharmaceutical systems

Lab Vantage Pharma is preconfigured based on industry best practices to support pharmaceutical specific workflows, such as batch management, stability testing, reagents and standards management, and barcode label printing.Other LIMS vendors do not provide fully executed validation, but instead supply only validation test scripts.For more than 60 years Ellab has been a leading manufacturer of process validation and monitoring systems used in the food, medical device and pharmaceutical industries.These systems monitor temperature, pressure and RH and are designed for validation applications that require compliance with FDA guidelines and international GMP standards.CSV (Computer System Validation) is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for a certain industry.

Processes Needed for Computer System Validation CSV is dependent on the complexity of the project and can be largely broken down into the following processes: This checks whether the specifications are in line with user requirements.These scripts then need to be rewritten to match the configuration and then executed.This adds substantial cost and likely does not cover the entire validation from the customer end.Often, companies tend to either overdo or underdo it.Lack of knowledge about how and what to validate can translate into too much documentation because of uncertainty as to where to draw the line or not enough information because the validation task seems so daunting.The term validation in the context of pharmaceutical manufacturing can easily be misinterpreted and because of that, companies must define specifically what it means for them and detail how exactly they will implement it in order to achieve the desired results.


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