IT compliance for pharmaceutical companies is best achieved through collaborative innovation
There is no benefit to pharmaceutical companies in having technology partners that stand on the sidelines as arms-length providers of standardised solutions and services.
That’s because the social and commercial implications of drug development cause regulators to walk a fine, continuously evolving line between enabling pharmaceutical companies’ sustainability and ensuring public safety. Using technology to help pharmaceutical companies achieve compliance must, therefore, be a pro-actively flexible process.
Regulatory latitude and cloud synergies
Until now regulations have been prescriptive and have not given pharmaceutical companies sufficient leeway for innovation in their research and development (R&D) and operations. However, this is changing and, by working with innovative and experienced partners, pharmaceutical companies can achieve more latitude while still complying with regulations.
The advantage of this latitude is that it supports the use of the cloud, with its cost-saving and productivity-boosting opex, on demand model allowing for maximum innovation and speed to market at massively reduced cost.
The down side is that it results in a distance between traditional cloud providers and pharmaceutical customers. The more so because regulations such as Title 21 Part 11 of the Code of Federal Regulations (CFR), which regulates drugs in the United States of America, stipulates that pharmaceutical companies must take primary responsibility for their IT compliance.
The commoditisation straight-jacket
Specifically, pharmaceutical companies must prove that no-one inside or outside the organisation can tamper with data or processes, most of which are governed by individual companies’ standard operating procedures (SoPs).
Most cloud providers take the view that, because they operate within IT industry best practice, their responsibility as to data and process security is fulfilled. In addition, the commoditisation of services that is inherent to cloud and confers its exceptional agility and low cost exacerbates the provider’s take it or leave it attitude.
However, as regulatory latitude acknowledges, innovation cannot be commoditised or straight-jacketed into conventional processes – and innovation is a baseline for pharmaceutical company survival.
So, what pharmaceutical companies don’t need is a conventional cloud provider. Cost savings and productivity benefits that strangle innovation are pointless. Why be efficiently and affordably uncompetitive?
It’s vital, therefore, to look for a cloud provider that is itself prepared to be adaptable and agile – by working with the company to ensure that its SoPs are executed in the cloud in such a way as to give it both agility and compliance in a single package.
After all, technology is evolving as rapidly as the life sciences. If your cloud provider isn’t interested in advancing its own facilities in ways that meet the evolutionary needs of its customers, you need a new cloud provider.
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