Frequently Asked Questions

The following is a list of FAQs covering equipment calibration and validation services. If you cannot find the information you want here, feel free to give us a call and we’ll be more than happy to address any queries that you may have.

Calibration Questions

Calibration certifies that the data output from your equipment is precise, reliable, and repeatable. Equipment calibration enables you to rule out faulty or damaged devices that could invite defects, unnecessary production recalls, and delays while ensuring regulatory compliance.

It is recommended to document the calibration history from the day a new instrument is dispatched from the factory. Ideally, devices should be recalibrated at least once every year. However, the frequency of usage, nature of the application, the quality of your system, and the conditions of use may warrant more frequent calibrations. If you are unsure, you can follow the manufacturer’s guidelines for your equipment calibration.

The accuracy of every measuring device tends to degrade with time due to wear and tear. However, accuracy can also be adversely impacted by mechanical or electrical shocks or due to a hazardous environment.

Depending on the type of device and the environment of the application, it may depreciate quickly or over a long time. If you’re using a device that’s not calibrated, then the results may be considered unreliable and incompliant in a professional environment.

Accreditation is the official recognition of an organization’s technical proficiency to conduct certain tests and calibrations. The standards and specifications for laboratory accredited calibration are contained in ISO/IEC 17025.

The basic types of instrument calibration can be divided into the following 3 categories:

  • Individual – Every device is individually tested and calibrated to ensure that a potentially defective product does not enter the market.
  • Batch – One device is randomly selected from the manufactured batch and tested to verify that the entire batch complies with the specifications.
  • Accredited – every device is tested and calibrated in compliance with the ISO/IEC 17025 standards following which it is reviewed and certified by a third-party to ensure the highest level of accuracy and reliability.

If you want to publish your measurement results or publicize your GMP compliance with quality processes like ISO certifications, then it is necessary to have laboratory accredited calibration. And the calibration certificate is a legally accepted document.

Accredited calibration labs ensure compliance with ISO 17025 standards. They control the environmental conditions including air flow, humidity, and temperature and use accurate equipment to give you greater quality assurance.

Onsite calibration services employ fully trained field service technicians who focus exclusively on the FDA environment. If you want to minimize the downtime associated with annual calibration requirements during FDA inspection or daily activities, onsite calibration services offer a quality, convenient, and cost-effective solution.

Our pricing depends on the complexity and the condition of the instrument. It also depends on the type of calibration service required and the difficulty of the procedure. Browse through our services for our full calibration scope.

Validation Questions

Validation becomes necessary when your instrument, computer system, or existing procedure is used in a GxP process or for product quality assurance. Also, if your system is being used to generate data that is to be recorded for FDA audits or to be submitted to regulatory authorities, equipment validation becomes important.

There are 4 distinct types of process validation:

  • Prospective Validation – is performed on the basis of preplanned protocols when a facility needs to be validated before commencing production or when implementing a new formula.
  • Retrospective Validation – is performed when a facility has not been validated previously and wants to avoid non-conformation problems.
  • Concurrent Validation – is conducted alongside the first production run and continued till all the runs are complete. It helps avoid unforeseen errors and unwanted outcomes.
  • Revalidation – involves the repetition of some or all the parts of the validation process. It applies to the instruments, computer systems, production, and the premises to maintain compliance and to sustain the validated status throughout.

A computer system validation is a prerequisite in the pharma industry to ensure strict adherence to pharmaceutical cGMP regulations that help companies maintain quality consistently. CSV ensures that any technology component that impacts public health and safety is compliant with pharmaceutical cGMP guidelines while meeting the purpose for which it is designed and developed.

A CSV assessment program is crucial in industries like pharma and biotech where non-conformance can have far-reaching implications. Computer system validation verifies the efficiency and effectiveness with which the system is serving the desired purpose.

Validation will eliminate the risk of non-compliance and ensure that your system performs at optimal efficiency.

FDA regulations are mandated to ensure quality consistency across the food and drug industries. These regulations are very strict so as to ensure the health and safety of consumers. If you are a part of this industry, implementing process validation will guarantee desired results with improved performance, increased outputs and enhanced quality.

cGMP is short for Current Good Manufacturing Practice. These regulations are enforced by the FDA to provide for systems that guarantee the right design, consistent monitoring, and complete control over manufacturing operations. Manufacturers need to follow current good manufacturing practices to eliminate the possibility of rejection and to ensure that products are high-quality and safe for use.

Timely and accurate documentation is needed to demonstrate that the system was tested for calibration, validation, protocol execution and product quality. Regulatory compliance mandates proper documentation.

Why trust RS Calibration for calibration and validation services?

  • A 17025 accredited lab complying with international standards enforced by the FDA and cGMP environments.
  • A full range of lab based calibration services focused on the FDA environment.
  • A one-stop calibration service that can calibrate new and used instruments using standards traceable through NIST for greater accuracy levels.
  • Fully trained field service instrument technicians providing a full range of onsite calibration services with greater assurance of quality.
  • High-quality industry-standard validation tools that provide reliable and repeatable results for all your temperature mapping validation projects with full customizability.

Want to ensure better control and tracking at reduced audit costs? Call us today at 1-877-799-0922.

Our Mission

RS Calibration Services will continue to be recognized as the most innovative company in the calibration & validation business.

We strive to maintain long standing, profitable relationships with our customers by providing timely, cost effective service within our targeted market in California.

RS Services has embraced a “Best Practices” program as an initiative to advance company-wide employee training and knowledge that will ensure continued quality services to our customers.

By challenging our employees and listening to our customers, in an environment focused on continuous improvement, RS Calibration will achieve our stated goals for growth and exceeding customer expectations.

Great Place to Work

  • Our Company embraces the Golden Rule Office Culture
  • Our employees embrace the diversity of our staff and customers
  • RS Calibration Management has commitment to a continuous, long term investment to our employees
1047 Serpentine Lane, Suite 500, Pleasanton, CA 94566
Call us today 1-877-799-0922
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