Focus provides innovative solutions to the FDA regulated industries. Our regulatory compliance specialists work closely with the FDA to ensure our clients have the latest information available and can quickly assess the impact of regulations. We offer our clients a unique blend of technical expertise, regulatory compliance insight, and practical hands-on operating experience. Focus has the resources to meet your project needs in the most cost-effective manner.

Validation and Qualification Services

  • Validation Life Cycle Methodology
  • Standard Operating Policy and Procedure Development/Implementation
  • Quality Assurance Planning
  • Validation Gap Assessments
  • Validation Master Planning
  • Process Validation
  • Equipment Validation
  • Validation Protocol Optimization
  • Protocol Development and Execution
  • Documentation Management (EQ, DQ, IQ, OQ, PQ, and Final Reports)
  • Change Control
  • Re-Validation Planning
  • Critical Facility and Utility Qualification/Validation (Water, Steam, Gases, Compressed air, Temperature, Humidity)
  • Environmental Monitoring Planning and Execution (Particulate Matter Control Planning, Sampling and Analysis Plans, Analytical Data Review)
  • Cleaning Validation
  • Corporate On-site Training
  • Computer and PLC System Validation

Risk Assessment / Risk Management Services

The FDA’s 21st Century Initiative is intended to integrate quality systems and a risk management approach into existing systems. Focus provides services and tools to assist clients in implementing a Risk Assessment/Risk Management Program within their company. In addition, Focus can help develop quality policies on risk assessment for your company, and then revise any necessary existing guidance documents and SOPs.

Corporate On-Site Training / Seminars

Focus Compliance & Validation Services personnel are speakers and presenters in the pharmaceutical, medical device, and biotechnology industries. Specific regulatory compliance and process validation issues pertaining to your facility are addressed as part of the program.