With an FDA approval expected in the near term, a Life Sciences company needed to ramp up its manufacturing capabilities. Operations needed to be established quickly which meant a short runway to get software validated and infrastructure designed, qualified and running. The IT team of the San Francisco based biotech was already stretched thin, evaluating line-of-business applications— from lab calibration software to MES—in addition to supporting startup operations.
A strategic technology partner
Understanding the importance of a unified technology strategy to support the scientific and commercial requirements of the company over time, the leadership recognized the need for expert guidance. A short search led them to Outer Edge Technology, whose experienced team had a clear understanding of the industry challenges and time pressures the startup faced.
Working with Outer Edge as a strategic partner, the team hit the ground running. While the internal IT team focused on evaluating the software that would best fit the business and operational requirements, Outer Edge vetted the software vendors with an eye towards delivering a cloud-based application. Once the software vendors were selected, Outer Edge professionals designed, built and delivered the supporting cloud infrastructure.
Best-in-class Life Sciences applications without compromise
One of the most common technology challenges Life Sciences organizations face today is the inconsistent technology of best-in-class applications. Many of the mature, high-function applications are only available for on-premise deployment. Others have made the transition to the cloud and are delivered through SaaS (Software as a Service) models. Each organization has unique requirements that are best served by a combination of these best-in-class, validated FDA compliant software solutions.
Through their experience with other biotechs, Outer Edge was familiar with the applications being evaluated. They understood how to deploy them through a unified, cloud-based infrastructure that would cost-effectively streamline process and data flows.
With the Outer Edge cloud-based platform, the biotech didn’t need to compromise on applications—they were able to deploy the best software to support their business model. Familiar with the applications and how best to configure the cloud deployment, the Outer Edge team was able to get systems up and running in the cloud in two weeks.
An extension of the team
Outer Edge served as an extension of the biotech’s IT team and was critical to their success. Confident the core infrastructure was being designed, implemented, and supported by an experienced team, internal staff were able to fully focus on enabling employees to quickly achieve full productivity. Through more effective use of internal resources, the biotech was able to focus on business critical operations, troubleshoot user issues and train employees quickly.
Expert, proactive guidance
As a strategic technology partner, Outer Edge has developed a strong relationship with their customer’s IT and executive teams. Participating in status calls from the inception of the project, Outer Edge has proactively recommend solutions that will keep pace with the company’s growth and today’s ever-changing technology. With a clear understanding of how leading-edge technology can impact and benefit the Life Sciences industry, Outer Edge professionals bring unique depth and expertise to the team.
Checklist for regulated cloud infrastructure partner evaluation
As you evaluate partners to support your unique technology requirements, MSPs should be able to demonstrate their ability to provide:
- A track record of participating in the FDA validation process
- The evidence for the IQ validation process
- The design and management of multiple platforms including AWS and Microsoft Azure
- References for successful regulated cloud deployments and ongoing management
- Private dedicated servers, network, firewall and storage, designed to meet strict regulatory requirements
- Full redundancy, vigilant security and performance monitoring with high data availability and integrity
- Data security processes that support full regulatory compliance in addition to enhanced disaster recovery and business continuity
- Strategic guidance to evaluate network designs and improvements to keep up with ever-changing technology
- Complete managed technology services including LIMS, MES, Stability Systems, Calibration Management, Building Automation and other LOB applications specific to the Life Sciences industry