C-realize IT Services

The C-realize mission is to enable life science companies digitalize and streamline their business and quality processes through IT integration with the cloud while maintaining compliance with regulations.

It can construct digital quality management systems that are cloud-native, as well as provide computer systems validation and IT infrastructure qualification for FDA Part11, EMA Annex11, and other regulatory compliance.

C-realize portfolio

C-realize products and services are focused on the specific business and regulatory demands of pharma, biotech and medical device markets, including patient safety, product quality and data integrity.

Over the years since its founding, C-realize has experienced rapid and continuous growth, assisted by its advantages in providing fast response, single point of contact and deep experience in computerized systems validation and compliance for the life science industry.

Its core capabilities are in quality-driven agile and lean software design, development and testing, along with computer systems validation, secure cloud computing services and other regulatory compliance solutions tailored for Pharma, Biotech and Medical Devices. These abilities are harnessed to offer four main service streams.

Agile Software Development and Testing

C-realize develops software following an agile and quality driven software development lifecycle based on industry best practices and regulatory standards.

C-realize build its own digital Quality Management System. The OpenQMS.net application is available as a lightweight, cloud-native and scalable end-to-end Quality Management System software solution that can easily be deployed as stand-alone on-premise installation or delivered as a hosted app.

This open source and free-to-download application is designed and built to meet biopharmaceutical quality standards such as GXP, FDA Part 11, and EMA Annex 11.

Based on Microsoft’s .NET framework, OpenQMS.net can easily be integrated with Office365, Azure cloud and other Microsoft technologies.

Computerized Systems Validation (CSV)

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.

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

It is able to 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.

Secure and Compliant Cloud Computing

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.

This service stream includes Cloud Services and Solutions in which C-realize is able to host any application in a qualified environment at very competitive rates. It can also build cloud-native microservices to integrate different systems that are currently isolated and siloed within the client organization.

The company’s location in Romania’s Cluj-Napoca region takes advantage of the area’s status as a recognized tech hub for southeast Europe.

Quality / Security Auditing and Training

C-realize also offers an auditing service that benchmarks organizations and their partners/suppliers for data integrity,  information security and effective quality management that can be accompanied with personnel training adapted to client organization needs.

As with all C-realize products and services, the precise audit and training solution will be developed according to individual life sciences client circumstances and needs, and as the product of intensive consultation.

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.