Calibration and Validation in the Life Sciences Industry

Calibration and Validation in the Life Sciences Industry

Calibration and Validation are critical regulatory requirements of the Life Sciences Industry.

If you are looking for Calibration Services, Calibrated Equipment Rentals, or Validation Services, contact PSC Biotech at www. Biotech.com.

FDA defines validation as “…a process that is required to establish documented evidence to assure that a specific system, equipment, computer system, or process will consistently meet the requirements and its intended use.”

All organizations need to validate their systems, computers, equipment, and processes that have GMP impact.

Calibration is the process of determining the accuracy of the measurement system over its intended range of use against the defined standards. Life science companies calibrate their instruments to measure process parameters.

  • Temperature
  • Relative Humidity
  • Pressure
  • Flow
  • Volume
  • Mass
  • Length

Are Validation and Calibration Different?

Yes.  You can’t validate unless you calibrate first!  Calibration assures the accuracy of your measurements.  Validation uses your measurements with your calibrated instruments to provide documented evidence that whatever you are validating meets your user requirements for its intended use.  Whether it is calibration or validation, PSC Biotech can meet your needs.

PSC BiotechTM Metrology is our Metrology laboratory and pharmaceutical validation service with experience and skill in serving the life science industry across the globe.  PSC Biotech Metrology provides calibration services and rents calibrated equipment to ensure that your facility stays Gap compliant.

Our Metrology Unit offers the following range of services:

Instrument Calibration Services:

  • Calibration of temperature, humidity, pressure, and mass
  • Metrology plan review and preparation
  • Field instrument calibration
  • Reference instrument calibration

Calibrated Equipment Rental Services

  • Kaye® Validators, LTRs, HTRs, SIMS
  • Lives® International Wireless Data Loggers
  • Ellabs® Wireless Data Loggers
  • Cryopack® Wireless Data Loggers
  • CLiMet® Particle Counters

PSC Biotech also provides the professional services to execute your validation program.

Validation Services

  • Reviewing and preparing for the validation master plans
  • Gap analysis and risk/impact assessments
  • Qualification and validation, including validation plans, design, installation, operational and performance qualifications
  • Support to implement remediation program
  • Equipment commissioning (factory and site acceptance tests)

Process and Quality Support

  • Third-party and supplier assessment, qualification, and auditing
  • Remediation plan management
  • Risk and gap analysis support
  • Cleaning process development and validation
  • Technology transfer support
  • Regulatory support for the preparation and upgrade of document types
  • Processes and primary packaging validation
  • Inspections and audit preparation along with annual product reviews
  • GMP support (i.e., variations and deviations management)
  • Internal processes analysis to boost the efficiency of the company

If you are looking for Calibration Services, Calibrated Equipment Rentals, or Validation Services, contact PSC Biotech at www. Biotech.com