Cloud-based software for the pharmaceutical industry

30 August 2019

Cloud-based software is the future, states Andrew Davies, Managing Director of Microgenetics. It demands a subtly different mindset on validation for pharmaceutical purposes, but advantages of cloud based pharmaceutical software mean it should now be the platform of choice for any new application. This is why we have developed SmartControl, a cloud-based environmental monitoring management system.

In recent years the mass uptake of cloud computing systems in many industries has been widespread, but so far the pharmaceutical industry has lagged in capitalising on the advantages offered. Often the principal objection is a misconception that cloud systems somehow increase the security risks. This is an unfortunate, yet understandable, confusion due to some high-profile security breaches that occurred due to poor personal security rather than poor cloud security.

Adopting cloud-based software offers three major opportunities for pharmaceutical companies:

1. Improves data storage security and reliability

Most experts agree that cloud services are more secure than traditional on-premises server software installations since big cloud providers can invest far more into developing and maintaining their security than a typical IT team. Furthermore, the reliability of data storage is ensured through the use of backup hardware and replication across multiple, physically separate data centres.

2. Removes the burden of upgrades

Historically, IT departments had to procure, install & qualify hardware that had to be maintained and patched throughout its life cycle. Applications would need to be installed and validated, and any updates (either bug fixes or new feature releases) were often only available for a fee and had to be managed. This was all highly resource- and cost-intensive. With cloud-based software, updates are provided, pre-validated and managed by the supplier at no cost, meaning all customers have access to the most secure, feature-rich version of the software.

3. Leveraging supplier validation testing

Regulators want to see companies maximising on testing carried out by suppliers, but in many cases, this is impractical due to custom configurations and opaque supplier testing regimes. This leaves the burden of functional testing with individual customers rather than achieving the economy of scale that a supplier testing a single software version can achieve. Suppliers like Microgenetics can execute the bulk of the validation testing and share the results with customers for their implementation.

Validating—and maintaining validation of—cloud software does require some straightforward changes to the traditional software validation approach. Since the supplier controls the release cycle, customers must consider the most appropriate change control methodology for approving those releases.

Diagram showing validation responsibilities for traditional versus cloud-based software. In cloud-based software, OQ is performed by the supplier rather than the customer.
Customer validation effort (in red) is significantly reduced when supplier testing (in green) is leveraged.

The extent of supplier validation testing means that the customer change control process can be limited to reviewing the test certification and deciding which optional new features will be adopted. Microgenetics SmartControl® gives ample notice of such releases to allow time for a change control procedure to take place and provides access to tested environments, where the updated software can be previewed. SmartControl also ensures that changes have a negligible impact until you choose to enable them – so you only need to re-train staff if you wish to enable a new feature (and Microgenetics provides training for each new release).

When Microgenetics set out to create SmartControl, they had two main aims: make software that has data integrity at its heart, and make it easy to install, validate and use that software. The decision to host the software on the cloud was evident given the benefits that customers yield in improved data security and regulatory compliance as well as initial and ongoing validation effort.

If you would like to learn more about how Microgenetics SmartControl® could transform your environmental monitoring management, then get in touch by emailing