Risk Management is a thread that runs all the way through the Computer System Validation (CSV) process, from Initial Assessment to final testing

One of the first and most important steps in Computer System Validation (CSV) is Validation Planning.

Computerized systems used in the development, manufacturing and throughout the lifecycle of biopharmaceutical products and medical devices need to be validated for GxP and other purposes.

C-realize has authored a White Paper that identifies the key actions that life sciences businesses need to take to maintain secure IT and ensure GxP compliance

Nonconformance management ensures that any deviation from internal procedures, contractual agreements, laws and regulations are identified, addressed and prevented from recurring. It is a fundamental...

C-realize helps companies of all -sizes plan and implement a secure and compliant data lifecycle including transfer of data from one IT system to another

A singular event in mid-July 2024 underlined the importance of risk management in IT systems. The CrowdStrike disaster exposed risk management failures on multiple levels

C-realize has developed agile automated test procedures and tools that offer significant benefits when it comes to installing new software or updating existing systems

C-realize has developed OpenQMS.net as a lightweight, scalable and Cloud-native open-source web software application that is free to download and use

C-realize helps companies in the life science industry and their suppliers with plans, guidelines, checklists to setup a Software Development Lifecycle (SDLC) which ensures compliance with FDA 21 CFR...

C-realize offers its Auditing & Training service to life sciences clients who need assurance that their organizations and suppliers are performing flawlessly for IT systems quality and data security.

Pharma industry IT specialist partner C-realize has released OpenQMS.NET 1.0 as a new major version of its open-source end-to-end Quality Management System solution.

The C-realize mission is to enable life science companies to adopt leading edge IT and adopt full digital integration for enhanced workflows, quality

C-realize offers OpenQMS.net as an end-to-end Quality Management System software solution that can easily be deployed as stand-alone on-premise QMS system installation or delivered as a hosted...

The C-realize IT Governance and Compliance service stream enables pharma and life sciences clients to embed the robust quality and information security management systems that have become key...

Computerized Systems Validation (CSV) Part 10Quality Assurance - CSV - Software Validation - SDLCOnce a system is validated it needs to be maintained and kept in a validated state. In this last post...

C-realize’s mission is to enable life science companies digitalize and streamline their business and quality processes through IT integration including computer systems validation and IT infrastruc...

pharma industry partner IT specialist C-realize has rolled out its Agile Software and Development Service that applies latest methodologies and tools while maintaining control to meet high quality...