Lighten your validation load with cloud-based pharmaceutical software

11 May 2022

When implementing any new system into your pharmaceutical manufacturing facility, it’s important to ensure that effective validation is performed. Computer System Validation (CSV) is traditionally a long-winded process, sure to demand significant time and resource from you and your team to verify compliance. However, by taking your software to the cloud, you can streamline these processes for a faster, more efficient validation process.

We’ll use SmartControl EM in this blog as an example of cloud-based software for the pharmaceutical industry. Developed by Microgenetics, SmartControl EM is a dedicated environmental monitoring solution, with a range of easy to use yet powerful tools to help you streamline the EM process, gain insight into your facility and ensure regulation is met.

Using cloud-based computer systems such as SmartControl EM, the software supplier can perform much of the testing required. These tests can then be leveraged by you, reducing your time and effort in validating the software. This means that you can spend more time getting to grips with the latest features and use SmartControl EM to make better decisions with your data.

How is computer system compliance tested?

For anyone new to the validation of computer systems, CSV is the verification that a software performs as intended, and that it consistently and reproducibly fulfils user requirements.

Good Automated Manufacturing Practice 5 (GAMP 5) is the latest set of guidelines used to evaluate computer system compliance, with most pharmaceutical companies now employing the GAMP 5 approach to validation. The GAMP approach can be summarised by the diagram below which shows the relationship between user requirements and specifications, and the testing performed as part of the verification process.

System build configuration

The types of specifications associated with a piece of software are intrinsically linked to the systems’ intended use and its complexity, which in turn determine the verification activities required to validate the system.

GAMP classifies computer systems into 4 categories dependent on complexity, with SmartControl EM falling under Category 4 – Configured Software. As such, customers are required to execute performance qualification (PQ), operational qualification (OQ), and installation qualification (IQ) testing. This testing verifies user requirements, functional specifications, and configuration specifications respectively.

Why is the validation of cloud-based solutions easier for you?

With traditional software validation, a lack of transparency regarding supplier testing means that the responsibility of functional testing lies with you as the customer. However, with cloud-based software, the emphasis is on vendors to carry out extensive functional testing, so you can simply leverage supplier test results for your implementation.

Validation

This not only allows you to save time, money, and resources, but you can also limit change control processes to review the test certification and decide which features you wish to enable.

When our testing is leveraged, your validation effort can be significantly reduced. This easy initial and ongoing validation will enable you to start using SmartControl EM and its newly developed features sooner, so you can meet regulation, enhance data integrity and take better environmental monitoring decisions.