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Benefits of automated validation for regulated industries
There is still a lively debate in pharma IT and business-management circles over the usefulness and security of true (multitenant) cloud-based software systems, which take computer code and applications out of on-premises computers and data storage, and keep them in a remote data server whose very physical location can change from hour to hour across an interconnected network like the industry leader, Amazon Web Services (AWS). Cloud-based systems have made substantial entrée into customer relationship management, some aspects of clinical research, and some aspects of business intelligence. But many pharma managers still hesitate to commit core functions like regulatory compliance, business financials or customer master data to cloud-based systems; the risks of hacked or stolen data are thought to be too high, and the lack of direct control over both hardware and software raises data-integrity issues.
By contrast, Sparta Systems, one of the leading software vendors in enterprise-level quality management systems (EQMS), has not only gone to cloud-based offerings; it provides two different platforms, and also provides for a transitional process for its legacy product, TrackWise. “We still find ourselves doing a lot of customer education on cloud-based computing,” says Bruce Kratz, VP, R&D at the firm. Kratz tackles one of the most common objections to cloud-based systems---the difficulty of validating an IT system whose physical location and version control is not in the hands of the user—by pointing out that Sparta’s systems (as do some others in the cloud ecosystem) have automated validation so that it’s performed daily or even more frequently. “Automated validation has been in use in IT circles for quite a while now,” he points out, “but it’s only come slowly into the pharma manufacturing world.” With automated validation, the days of having a semi-annual audit and review of IT systems to meet regulators’ demands are history; the cloud-based system is continually updated and validated.
Sparta has two cloud-based offerings: Stratas an EQMS operating on AWS, and 123Compliance, an EQMS for small to medium businesses that is provided on the Salesforce Cloud platform. (123Compliance was acquired just over a year ago by Sparta.) Both systems connect to the Stratas Supplier Collaboration Suite, which can connect CMOs or other suppliers to the manufacturer, as well as trading partners, for comprehensive supply chain visibility. TrackWise, which Katz says is about to be released in an extensively updated new version, is used frequently by customers as an on-prem system, but has links to connect parts of it to the Stratas network.