GMP Calibration Regulatory Maintenance

Keep up  to date on all your the the requirements set forth in the Code of Federal Regulations for calibration of instruments.

LFE/CFV Flow Computer, Calibration services

1300 Industrial Road #22
San Carlos, CA 94070

3656 Ocean Ranch Boulevard
Oceanside, CA 92056

Calibration Services California

58 Tesla
Irvine, CA 92618

GMP Regulatory Readiness

International Process Solutions is a company that provides calibration, maintenance and validation services to companies in the life sciences industry. IPS maintains a quality system that is specifically designed to conform to the requirements of the cGMPs. IPS also maintains accreditation to ISO 17025:2017.

Any company engaged in the development of pharmaceutical or biotech products or medical devices must comply with the requirements set forth in the Code of Federal Regulations for calibration of instruments that are used in the manufacture of said products, or that are a part of the product itself.

IPS has extensive experience in helping companies comply with these requirements.

We can assist you, if you are establishing a new business entity and have need of a Standard Operating Procedure (SOP) framework to manage your assets, or if you are an established entity but could use a hand in maintaining regulatory readiness.

Here are some of our capabilities:

  • Corporate level policy creation for calibration programs
    SOP development for specific disciplines, (temperature, pressure, etc.); either generic or highly specific that meet the needs of the cGMPs and/or ISO.
  • Calibration interval selection using risk analysis
  • Evaluation of individual instrument calibration requirements with respect to process criticality
  • Establish instrument management programs, requirements definitions for assets, document organization systems
  • Establish calibration programs that meet the requirements of ISO 17025:2017



One stop shop for calibration services, we can handle everything from your calibration to database management
Calibration services in San Diego, Los Angeles, Orange County and San Carlos

Ongoing readiness program maintenance requires that you periodically review the effectiveness of your program. We can help with that:

  • Create audit plans to systematically evaluate your existing program
  • Execution of audit plans
  • Implement corrective actions, identify areas for improvement
  • Monitor and evaluate the effectiveness of corrective actions

Has the FDA cited you? Do you need assistance in regaining compliance with respect to your calibration program? We have direct experience in helping companies in remediation to address 483 observations, to get you back into regulatory compliance.