Obtaining IQ Validation Evidence for FDA

Why Life Sciences Companies Leverage Managed Regulated Infrastructures to Smooth the Path to FDA Approval

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From start up through production, Life Sciences companies depend on validated FDA-compliant software applications and quality systems to support operations. The qualified infrastructure required to run those applications smoothly is technologically complex, requiring careful design, planning and support from IT teams to achieve and maintain regulatory compliance. Life Science leaders rely on technology experts to manage the infrastructure foundation, so they can retain focus on research and production.

Proven Software, Diverse Platforms

The exacting, regulated business of producing drugs, medical devices and other biotech products requires proven, validated software and qualified computer systems. Applications that calibrate laboratory equipment, maintain consistent manufacturing environments, track documentation and much more provide the control and process foundation for every Life Sciences company.

Unfortunately, there is wide variation in the technical requirements of the many best-of-breed biotech applications common today. Many were developed for on premise deployment, while recently developed applications are likely to be cloud-ready. Regardless of their technology, they need to coexist—seamlessly.

Function First, Technology Second

To support operations in a Life Sciences company, the functionality is far more important than the technology platform. Applications must have a proven track record—used by companies that have successfully participated in the FDA approval process.

The infrastructure and tech support required to run the applications is secondary, but still a critical consideration. Which is why Life Sciences companies look to technology experts—professionals who have already navigated the complexities of the industry’s leading software and understand the infrastructure requirements of FDA- regulated operations.

Cloud Options to Fit Industry Needs

Today’s market offers a variety of cloud deployment options, requiring guidance from specialists immersed in the changing technologies. Technology experts will evaluate the options—whether public, on premise, or hybrid—to design infrastructures that meet their corresponding validation processes. Cloud environments support seamless management for the combination of traditional on premise software and cloud-based software applications preferred by Life Sciences companies.

In addition, cloud environments readily conform to mandated security and redundancy requirements that are common in regulated environments. The combination of flexible application administration, high availability and state-of-the-art security makes today’s cloud the platform of choice.

To administer and support the technology foundation, qualified Cloud Service Providers (CSPs) can ensure high-availability, monitor uptime and manage workloads—as well as provide day-to-day support. Collaborating with the right CSP delivers predictable technology costs and enables the in-house IT team to focus on more strategic initiatives that are routinely delegated by senior leadership.

Cloud Fuels Speed to Market

For early stage Life Sciences companies, cloud deployments provide the critically important benefits of speed and scalability. Non-revenue generating companies can devote more resources to research and testing, yet be ready to launch into production promptly upon approval. Investors can be assured that with flexible cloud environments supported by the right CSP partner, the start-up is prepared to act quickly when FDA approval is achieved.

What to Look For In A Regulated Cloud Infrastructure Partner

As you evaluate partners to support your unique technology requirements, CSPs 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.
  • 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

At Outer Edge, we are focused on the Life Sciences industry. We have experience with the applications you use on premise in addition to our own private data centers, and AWS® and Microsoft Azure® environments. Please call us today at 844-OET-EDGE or schedule an appointment at info@OuterEdge.bizif you have any questions regarding Managed Regulated Infrastructures or any other IT related topics or services.


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