Understanding the Difference between Calibration and Validation

In every manufacturing facility, calibration and validation must be carried out to assure high quality of the product. You must carry out these processes on a regular basis, rather them being just a one-off activity, if you want to meet all the regulatory requirements. Let us learn more about them. Calibration – A Brief Overview […]

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All About the Quality Management System

Quality Management System refers to a set of processes, policies and procedures that are required for planning and execution in any core business area of a company. It is a system that an organization follows to reduce and eventually eliminate non-conformance to standards, specifications and expectations of a customer in a cost efficient manner. Some […]

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Facility Validation and Pharma Manufacturing

Pharmaceutical companies face multiple challenges when setting up a new facility or upgrading an old one. Since the nature of the product is prone to numerous safety measures, there is a standard set that ensures the process involved follows current Good Manufacturing Practice (cGMP). However, the validation of pharmaceutical cGMP may require investment; this process […]

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The Why and What of Computer System Validation in Pharmaceuticals

CSV (Computer System Validation) is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for a certain industry. It is especially crucial in FDA-regulated industries like biotech and pharma, since products from these sectors impact public health and safety. Why Computer System Validation? […]

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Validation Program Assessment and Pharmaceutical cGMP Compliance

As implied by the name, validation is the process which verifies whether defined quality and compliance standards are being met by a product in the real-time environment. The evidence obtained through this process is then documented in a structured manner, making it available for review and cross-verification when needed. The importance of the validation process […]

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A Guide to Validation Master Planning

Quality engineering services are geared towards the management, development, operation and maintenance of quality attributes, and are essential for companies of all sizes, since they can help make sure that quality standards and requirements are met across the board. Validation of products, processes and facilities is an important part of a company’s QMS (Quality Management […]

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FDA Process Validation 101 – A Complete Guide

It is common knowledge that any company within the Food and Drug industry has to maintain certain sets of standard of their products. They cannot create benchmarks unique to themselves and compare the results with those individual standards. Food and Drug Administration state this would cause disparity in composition of similar products, compromise their quality […]

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Equipment Validation Explained

Equipment validation is a term used to describe a set of independent procedures that are used to check if a product meets the specifications and requirements of its intended purposes. Regulatory agencies around the world have strict requirements for quality, procedures, performance testing, safety checks and the like, for a wide range of products. The […]

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RS Passes Annual ISO Audit

RS Calibration Services is proud to announce it has again successfully passed the annual International Organization for Standardization (ISO) Audits. The annual surveillance audit, performed by SAI Global, is necessary for the company to maintain ISO 9001:2008 certification. The audit, performed on December 4, is designed to assure continuing compliance and full evaluation of requirements. […]

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