C-realize Computer Systems Validation CSV Services

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 infrastructure qualification.

This service meets the need of pharma and life sciences companies who need to validate new and operational IT systems to comply with the requirements of FDA Part11, EMA Annex11, and other regulatory guidelines. The service produces a complete validation package that clients can present to customers and regulators for audits and inspections and includes ongoing support through all phases of the development life cycle to provide clients with a superior and more agile service.

CSV Computerized Systems Validation

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. At the same time, the life science industry needs technological expertise to cope with the fast pace of innovations and increasing digitalization while complying with regulations to assure patient safety, product quality and data integrity.

C-realize can validate new and legacy IT systems to comply with FDA Part11 and/or EMA Annex11 regulatory guidelines, supporting clients through all phases of the development life cycle and constructing a validation package that meets the requirements of auditors and inspectors.

This is a pragmatic approach that is quality driven and cost efficient, with a focus on measurable added value and reliability.

CSV service advantages

C-realize holds certification in Computer Validation Management by the European Compliance Academy and membership to the ISPE International Society for Pharmaceutical Engineering.

It can meet all requirements of relevant life science regulations and quality standards, including GxP regulations, Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11), EU GMP Annex 11: Computerized Systems (Annex 11), ISO 9001, and ISO 27001.

C-realize’s founder and CEO Hao Wang has over 15 years’ experience in computerized systems validation applied to life science industry quality and regulatory compliance serving various world leading organizations as well as smaller/medium-sized companies. It is also the core expertise of C-realize most sought by customers.

Agile methodology

This in-depth knowledge has enabled C-realize to develop a distinctive approach that combines agile methodologies based on hands-on experience applied in modern software development with industry best practices and regulatory standards.

It applies these agile methodologies combined with over 15 years’ experience. Together, these allow C-realize to deliver to the promise continuously and consistently while meeting industry standards and regulations.

The service enables client life sciences companies to reinforce trust among customers and regulators by meeting quality and compliance requirements allowing for increased data integrity and accessibility and faster exchange of information, at the same time they can increase competitiveness through streamlined, automated, paperless processes.

Digital QMS

Compliance is not achieved through a one-time validation but rather an ongoing process that needs to be continuously controlled in combination with a quality / information security management system.

C-realize uses a proprietary Software Development Lifecycle based on GAMP protocols to build its own OpenQMS digital Quality Management System based on Microsoft’s .NET framework for easy integration with Office365, Azure cloud and other MS technologies.

The OpenQMS.net application available as a lightweight, cloud-native and scalable end-to-end software solution that can easily be deployed as stand-alone on-site installation or delivered as a hosted app. This digital QMS solution plays a valuable role in making the CSV process much easier to manage and maintain over the medium to long term.

Resources

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C-realize provide help and support for all your Pharma, Biotech and Medical Devices needs in software development, cloud computing services and regulatory compliance advice and solutions, to learn more please book in a Introductory Consultation Session.