A computerized system may include hardware, software, peripherals, interfaces, equipment, users, and operating procedures. Today, software and hardware components are used in the health products industry, which includes pharmaceuticals, biologics, vaccines, biotechnology, natural health products, medical devices, cosmetics, and allied industries. They are used for data processing, data storage, and process control.
GxP Cellators, a computer system validation consultant in Canada, is committed to understanding your unique situation and supporting a comprehensive Computer System Validation (CSV) program that ensures strict regulatory compliance.
According to the US FDA, computer system validation is the process of providing a high level of assurance through documented evidence that a computer system consistently meets its predetermined or intended use or quality attributes such as accuracy, security, reliability, and functionality.
As computer system validation consultants in Canada, we have completed computer system validation projects for custom, off-the-shelf (OTS), and highly configurable Enterprise Resource Planning (ERP) computer system applications.
We have validated Laboratory Information Systems (LIMS/LIS), Electronic Data Capture (EDC) systems, and medical device software in "GxP" environments in addition to ERP. All projects adhere to internationally recognized quality standards such as ISPE's Good Automated Manufacturing Practices (GAMP 5 Guide: Compliant GxP Computerized Systems), the US FDA's 21 CFR Part 11 Regulations & FDA Software Validation Guidance, and the European Medicines Agency's Annex 11 Regulations on Computerized Systems.
GxP Cellators is a computer system validation consultant in Canada who can assist in determining which areas of the regulated process or medical devices require validation. Whether you use the Agile Methodology or the System Development Life Cycle (SDLC), we can provide you with expert advice throughout the entire project life cycle.
Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use. This is according to FDA software validation requirements for medical devices. This requirement applies to any software used to automate any aspect of the quality system, including device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling. We have extensive experience performing medical device software validation for clients worldwide.
Savings on expenses
GxP Cellators is a CSV consultants in Canada who prefers to support clients interactively to facilitate a smooth transition to the client's in-house IT and quality teams and, most importantly, to provide cost savings.
When is it necessary to validate a system or a device?
When is it appropriate to validate a system or device? To what extent is validation required? The extent of validation is proportional to the system's risk in terms of patient safety, data accuracy and security, and/or the nature of the change. Before designing a validation strategy with our clients, we at GxP Cellators assess the purpose and risks associated with each system. Although agencies do not recommend it, GxP Cellators has performed numerous retrospective validations of numerous existing computerized systems.
In conclusion,
GxP Cellators has extensive computer system validation experience and has completed CSV projects for custom, off-the-shelf (OTS), and highly configurable ERP computer system applications. We assist our customers throughout the validation life cycle by using a multidisciplinary approach to validate computer systems and close any regulatory or compliance gaps. You can contact our CSV expert to better understand our solutions.