Regulations and Standards Computer System Validation

Overcoming Validation Challenges in Biotech

Regulations and Standards Computer System Validation


Validation. A crucial element of the pharmaceutical industry that ensures compliance, protects consumers and ultimately, saves lives. But while it’s undoubtedly a positive part of the process, validation also represents legislative burden for small/medium businesses.

Even for larger companies, validation is a time-consuming obstacle. They have to build and maintain validation software, which consequently has a significant impact on IT infrastructure and costs.

But for more modest Pharma companies and CROs, the picture is considerably worse. Setting up such an environment can take two to three full-time employees between six and nine months to complete. Additionally, initial and ongoing IT costs and infrastructure needs to be set against much smaller revenues, representing a much larger and disproportionate cost.

There’s also a level of uncertainty and risk that comes with investing in validation environments. When an organisation decides to build its own software, there’s no guarantee that it will pass validation audits. And valuable IT resource that could be deployed on more value-adding tasks is then tied up. This is a particular issue for CROs, considering that the software isn’t needed 100% of the time – the demand for such software is variable.


New validation solutions are required to ensure competitiveness

And to make things worse, validation doesn’t even affect a core part of the business. So small/medium organisations are left in a bittersweet situation whereby they need to invest in IT skills and resources, together with validation expertise, in something that inherently adds no revenue to their core offering.

Some workarounds do exist. CROs, for example, can use the validation software of the organisation they contract with. But these workarounds are not long-term solutions. Large Pharmas will typically insist that the CRO complies with their rules and standards, thus creating yet another layer of training and burden.

So, what we’re left with is a situation where small/medium organisations still need validation software, but steep building and maintenance costs renders the responsibility of owning their own infrastructure debilitating.

And companies need expertise and resource in this non-revenue-adding area. How can these small/medium sized companies maintain validation software without significantly harming profits, in a competitive marketplace of squeezed margins and ever increasing legislation?


High performance, cloud-based validation products are here

So here comes the good news. Fresh new alternatives are emerging that work to take away the pain of building and running your own validation software. Accel provides cloud based, pre-validated software (which is therefore guaranteed to pass audits), small/medium companies finally have the ability to do things differently.

Designed for small/medium Pharma companies and CROs, pre-validated cloud solutions remove the need for expertise in a non-core area of the business and the burden of developing and managing the environment. It offers the agility and IT assistance you need, when you need it, while at the same time taking away the need for clinical systems validation.

For more information on Accel, the benefits pre-validated cloud-based SCE, view our video and Accel product page.

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