A Life Sciences CIO’s guide
to FDA compliant hosting

6 expert insights







Your task is a tough one.  You’ve got to ensure your organization supports compliance to the FDA and other global regulatory agencies. That means understanding the FDA’s regulations and applying their “Current Good Practices” to meet consumer safety concerns related to your laboratory, clinical trial, manufacturing and distribution activities.


That’s not all.


For computerized systems, there are additional regulations for protecting electronic records, electronic signatures and electronic submissions. And as the use of technology increases, you must keep pace with all the change without jeopardizing consumer safety.


If meeting a myriad of regulatory requirements weren’t enough, you’re also charged with reducing costs, increasing efficiency and bolstering security. Feeling overwhelmed? It’s understandable.


The good news is your task is not impossible.


So how do CIOs in the Life Sciences Industry (Pharmaceutical, Biologics, Medical Devices and Nutritional) meet regulatory compliance while avoiding costly obstacles and time-wasting missteps? Well, many rely on the support of a highly-skilled hosting provider. In this whitepaper you’ll learn six expert insights to help you select the right hosting provider — the first time.

Insight 1

Computer System Validation

Why It Matters


In FDA-speak, “validation” refers to the structured, documented verification of the entire lifecycle of an electronic system. More specifically, Computer System Validation refers to any computer system requirements that can impact consumer safety, product quality and data integrity in the Life Sciences Industry.

Computer System Validation can be defined as: Establishing documented evidence which provides a high degree of assurance that a computer system will consistently perform according to its pre-determined functional specifications and quality characteristics.

Here, functional specifications are the detailed system description in a list of the intended functions needed for system’s use and administration. Quality characteristics, meanwhile, fall primarily within the following areas that integrate into the functional specifications: 

  • Accuracy
  • Reliability
  • Security
  • Integrity
  • Traceability

These characteristics must be designed and configured into the hosted solution, objectively verified on the hardware and software components, managed through a combination of automated and procedural controls, and maintained and assessed through formal auditing. It is not sufficient to merely “test” quality; you must plan from the beginning and have processes in place throughout the System Development Lifecycle (SDLC) to make it a concrete reality. An experienced hosting provider can make validation much less vexing.