Is your laboratory dealing with strong regulatory compliancy, like pharmaceutical and clinical environments, where your software solutions has to be functional and in compliance with applicable regulations to minimize business risk. XiTechniX can help or support you in your computer system validation (CSV)! We have experienced QA managers, our software is FDA-proof and by using our prepared compliance packages you will gain lots of time and energy. The process includes a validation plan template that scopes out the validation process, test script development that sets up the test objective, a business requirements model, and a traceability matrix. The package includes installation qualification (IQ) test scripts, operation qualification (OQ) test scripts, a performance qualification (PQ) template, and a validation summary report template.
GxP guidelines were established by the FDA. They aim to ensure that businesses working in regulated industries manufacture products that are safe and fit for use, meeting strict quality standards throughout the entire process of production. GxP labs play a crucial role in the development and testing of new drugs, ensuring accuracy of results while meeting regulatory requirements such as the FDA’s Good Laboratory Practice (GLP)
CFR 21 Part 11
CFR Part 11 was established by the FDA in 1997 and it applies to Electronic Record & Electronic Signatures and their related rules. CFR Part 11 establishes a requirement that computer systems used to create, modify and maintain electronic records & signatures are subject to validation. Computer systems, controls and documentation must be at any time readily available.
ISO 17025:2005 is the international standard for testing and calibration laboratories. It's a set of requirements those laboratories use to show that they operate a quality management system and that they're technically competent to do the work that they do. It requires the lab to keep and maintain a lot of information around the technical data, such as calibration, maintenance, out of specs,....
ISO/IEC 27001, the international standard for information security. It’s a suite of activities concerning the management of information risks and shows you how to create, assess and continuously improve an effective Information Security Management System (ISMS) with a set of requirements. An ISMS based on ISO/IEC 27001 can help you protect the confidentiality, integrity and availability of all data within your organization.