compliance  +  regulatory  +  training
Services - Validation

Whether automating your Quality Management System, supporting your trials with CTMS or EDS, developing your own software solution or supporting your discovery and manufacturing with process-driven technologies, you are expected to demonstrate your control over operations and your technology systems. In collaboration with MethodSense, we can help you gain and sustain control over technology with strategies that achieve your business goals. MethodSense extensive experience developing both custom and commercial technologies for regulated industries, coupled with our regulatory knowledge, enables you to accelerate your commercialization process. For more information on our joint services, visit the Contact page.

SCI can provide guidance to clients on validation of manufacturing facilities, equipment, and computer technology, including development of all supporting documentation. Our solutions incorporate a practical approach, are based on “good science”, and ensure compliance to FDA and European validation requirements. Our team of experts has several years of experience in different aspects of validation, and focus on small companies and small project needs. Our experts can assist you with the following:

  • Development of validation strategies
  • Development of facility Validation Master Plan
  • Regulatory assessment of validation programs (Gap Analysis)
  • Oversight of validation execution for simple or complex pieces of equipment
  • Preparation for regulatory inspections
  • Review of validation protocols and writing of summary reports
  • Remediation of deficiencies

Our team focuses on small validation projects, but as a service to our clients, we can coordinate the contracting of personnel for execution of larger projects. Training is available through our Hot Topics Workshops.

In collaboration with MethodSense, Inc. we offer specialized services in the computer technology area.