Regulatory Affairs and Winning Regulatory Strategy Regulatory strategy development is critical for life sciences companies seeking to bring new drugs, medical devices, and other products to market. Developing an effective regulatory strategy can help companies...

Precision: Driving Success in Life Science through Calibration & Metrology
Metrology is critical to any life science manufacturing process in a highly technical and regulated industry. At PSC Biotech, we offer a range of metrology services to help our clients maintain equipment and systems compliance requirements and ensure their manufacturing processes’ accuracy, precision, and integrity. Â
Â
This blog post will explore some of the metrology services provided by PSC Biotech.

Precision and Perfection: All About MetrologyÂ
Metrology is the science of measurement and includes the study of measurement standards, measurement instruments, and measurement procedures. Accurate measurement is essential for ensuring the quality and reliability of products, and metrology provides the tools and techniques to achieve this goal. Metrology is essential for various reasons, including:Â Â
- Ensuring accuracy, reliability, and repeatability of measurements Â
- Improving product quality and safety Â
- Minimizing waste and reducing costs Â
- Facilitating trade and international standards Â
- Supporting manufacturing, engineering, research, and development Â
Accuracy Matters: The Role of Metrology in Industrial Environment of Quality Control Â
Metrology is an essential application in industrial quality control, allowing manufacturers to accurately measure the quality of their processes and products. Using precision instrumentation allows them to ensure that their processes and products meet customer expectations and standards. Additionally, metrology ensures that products are manufactured to the exact specifications and are consistent in quality. In addition to measuring the quality of products, metrology is also used in industrial control to monitor the performance of mechanized processes. By measuring the physical characteristics of a process, manufacturers can ensure that it is operating at peak efficiency (LEAN). This can help to reduce waste and improve the quality of the final product. Â
The Metrology Mindset: Achieving Scientific Measurement Perfection Â
Metrology is also important for scientific measurement standards. Scientific measurement standards measure and compare physical discipline phenomena such as temperature, humidity, pressure, vacuum, mass, time, etc. Metrology ensures that these practices are accurate, precise, and well-engineered. This is essential for conducting scientific experiments, ensuring reliable and reproducible results. In addition to scientific measurement standards, metrology is used to compare the accuracy of different instruments and measurements. This is important for ensuring that the results of the process are consistent, reliable, and repeatable. Â
Metrology services for the life science industry by PSC BiotechÂ
PSC Biotech offers comprehensive metrology services, including measurement of temperature, humidity, mass, pressure, time, and much more, whether on-site or sent to our lab(s).  Â
Instrument Calibration ServicesÂ
Calibration is comparing the readings of an instrument or measurement device against a known standard. Calibration ensures that the instrument is accurate and reliable and provides traceability to national and international standards. PSC Biotech offers calibration services for a wide range of instruments, including:
- In-lab calibration Â
- On-Site CalibrationÂ
- Instrument calibration process in-fluxÂ
- Metrology Training with custom on-site integrationÂ
- Instrumentation/ On-Site process auditingÂ
- Metrology Systems Design/ BuildÂ
- Metrology CMS/ CMMS Design/ Custom using ACEÂ
- Metrology Manufacturing Support Build/ FillÂ
- ISO 9001-certified calibration Â
Our calibration services are performed by highly trained personnel using state-of-the-art equipment. We provide a detailed calibration report that includes before (as Found) and after (as Left) readings, measurement uncertainty, and traceability to national and international standards. Â
Equipment ValidationÂ
Equipment validation is a documented process that verifies and ensures that a specific piece of equipment consistently produces results that meet predetermined specifications and requirements. Equipment validation aims to ensure that the equipment is fit for use and capable of performing as required. This process involves a series of tests and checks to ensure that the equipment operates according to specific standards and regulatory requirements. Â
- Autoclaves Â
- Incubators Â
- Freezers Â
- Refrigerators Â
- Centrifuges Â
Our equipment validation services include installation qualification, operational qualification, and performance qualification. We provide a detailed qualification report that includes test results, acceptance criteria, and recommendations for any corrective actions that may be required. Â
Validation Services Â
Validation ensures that a process or system meets its intended requirements and produces consistent results. PSC Biotech offers validation services for a wide range of processes and systems, including:Â Â
- Cleaning validation Â
- Computer system validation (CSV)Â
- Process validation Â
- Utility validation Â
- Equipment validation Â
- Thermal Mapping technology
Our validation services include protocol development, execution, and report writing. We work closely with our clients to ensure their processes and systems are validated promptly and cost-effectively. Â
Training Services Â
Training is an essential component of any quality system. PSC Biotech offers training services for a wide range of metrology-related topics, including:Â Â
- Metrology Course TrainingÂ
- On-Site TrainingÂ
- Calibration Systems AlignmentÂ
- Equipment qualification Â
- Procedures Â
- Metrology laboratory management Â
Experienced instructors lead our training services with extensive metrology and quality systems knowledge. We provide both on-site and off-site training options to meet the needs of our clients. Â
Consulting Services Â
PSC Biotech offers consulting services to help clients develop and implement effective metrology programs. Our consulting services include:Â Â
- Metrology program development Â
- Gap assessments Â
- Process improvement Â
- Regulatory compliance Â
- Auditing Â
Our consulting services are provided by experienced metrology professionals who deeply understand regulatory requirements and industry best practices. Â
Conclusion Â
Metrology is an essential component of any quality system, and PSC Biotech offers a range of metrology services to help clients achieve their quality and regulatory goals. Whether you need calibration services, equipment qualification, validation services, training, or consulting services, PSC Biotech has the expertise and experience to help you succeed. Â
Experience precision at its finest.
Contact PSC Biotech today. And if your organization is a Biotechnology Innovation Organization (BIO) member or a member of one of the state affiliates, you are eligible for significant savings on our professional services consulting.Â
See Also
PSC Software Solutions
Hire Consultants
PSC Biotech Services provide fast, budget-friendly, high-level expertise.
Follow Us
Share, Engage, Stay Current
Previous Published Posts
Regulatory Strategy Development for Life Sciences: Best Practices
The Secret to Writing Successful Grant Proposals
Grant writing aims to prepare and submit a proposal to request funding from a grant-making organization, such as a government agency, private foundation, or corporation. Grant writing involves researching potential funders, understanding their priorities and...
Benefit- Risk Assessment for Regulatory processÂ
Benefit-risk assessment is critical to the regulatory review process for life science companies and healthcare products, including drugs, biologics, and medical devices, before it is approved for use by regulatory agencies such as the Food and Drug Administration...