When working with ViridianTechs, you can expect a seamless, FDA and EMA compliant, customized solution to all your computer systems validation needs. With our consulting experience in the life science industry, we fully understand that computer systems are vital for a company’s success. Our specific areas of expertise within computer systems validation are included below. Developing and bringing life-changing drugs and devices to market: that’s your job. Expert computer systems validation consulting: that’s ours. You have enough to accomplish; let us be your resource for computer systems validation. As a global leader specializing in computer systems validation consulting services, ViridianTechs work to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines.
ViridianTechs has provided cloud-based document management software for life science companies around the nation. In highly regulated industries, computer systems are used to create, modify, and maintain documents to ensure accuracy, provide access to version and approval history, allow the classification of documents by use or type, and enable the ability to discern proper access and training assignments. Our CSV consultants are available to validate your existing electronic document management systems and laboratory management systems. Contact us for further computer systems validation integrated with equipment and other laboratory management systems.
Computer systems used to create, modify, and maintain electronic records and manage electronic signatures are subject to validation requirements to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. ViridianTech CFR Part 11 compliance reviews are based on a justified and documented risk assessment and a determination of the potential for the system to affect product quality, patient safety, and record integrity. ViridianTechs will work with you to review your existing validation procedures and documentation to identify any gaps in validation, define any remediation activities, and develop a training approach to ensure maintenance of compliance once our project is complete.
Our subject matter experts stay at the forefront of industry development and will assure your project's success. We will share our knowledge of regulatory agency mandates to develop a quality plan specifically for you. Let us know when you need help while preparing a new building, requalifying equipment, or have temperature excursions for us to investigate.