FDA Validations

As a member of the life sciences industry which is heavily regulated by the Food and Drug Administration (FDA), a fundamental concern is to ensure your company is fully compliant in accordance to regulated business specifications.

For pricing options, contact Xavor today!

FDA Validations

The Challenge

As a member of the life sciences industry which is heavily regulated by the Food and Drug Administration (FDA), a fundamental concern is to ensure your company is fully compliant in accordance to regulated business specifications.

Incorporated problems consist of:

  • Slow deployments due to numerous processes
  • High validation costs pertaining to each new release or product change
  • Spending too much time on audit accuracy

Root Causes

All products that your company ships out are required to conform to FDA  . In order to stay on top of these regulations as they are consistently changing, a process needs to be determined when a change needs to be validated. Any minor changes to the process will also need to be re-validated. With numerous changes, it impacts both the operations side of the company and adds significant expenses.

Solution

Xavor’s FDA Validations Solution not only provides medical and bio sciences companies with the build out of the protocol to meet FDA regulations but we will also manage and prepare your documentation as well as run it for you. Our services are based on the classic V-model as we have an extensive background in quality assurance and validation:

IQ – Installation Qualification

We evaluate your software and hardware that you are using with Oracle’s Capacity Planning Guide.

OQ – Operational Qualification

We verify all of your functional levels by making sure they are operating correctly.

PQ – Performance Qualification

After 30 days, we will ensure that your system is performing accurately.

  • Validation planning and project management
  • Software validation
  • IQ/OQ/PQ Protocol development
  • Test script authoring; execution, templates
  • Creation of a Validation Summary Report
  • SOP development, quality manual
  • Regulatory compliance assessments
  • Validation training

Contact Xavor today and begin to achieve the following:

  • Accelerated deployments
  • Lower costs/fines
  • Enhanced awareness of frequent changes with FDA requirement

Value

With Xavor’s FDA Validations Solution, your audits will go smoothly with hardly any non-conformances. Your quality standards will always be up to the mark. Quality departments will obtain more confidence with your products which will allow them be more marketable by passing the audit.