C-realize IT Services SRL

C-realize forms an agile IT partner for Pharma, Biotech and Medical Devices, providing software development, cloud computing services as well as regulatory compliance advice and solutions.

The company helps mainly small and medium sized biopharma and medical device companies, as well as life sciences sector specialist software vendors, to digitalize, streamline, and automate their processes, transitioning to Pharma 4.0 while meeting industry standards and regulatory compliance.

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

Activities & Products

The core capabilities of C-realize are in software design, development and testing, along with computer system validation and compliance, with a focus on the specific functional and regulatory demands of the life sciences markets, like patient safety, product quality and data integrity.

These abilities are harnessed to offer three main services:

• Agile Software Development: C-realize develops software following an agile and controlled software development lifecycle based on industry best practices and regulatory standards.
• Computerized Systems Validation (CSV): Validating 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.
• IT Governance and Compliance: 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.
• Quality / Security Auditing and Training: An auditing service that benchmarks organizations and their partners/suppliers for data integrity and  information security and effective QMS that can be accompanied with personnel training adapted to client organization needs.

C-realize also offers a range of IT services and products based on its skills in agile software development and awareness of the specific needs of life sciences clients. These include:

• Cloud Services and Solutions: 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.
• QMS Software: C-realize offers an end-to-end QMS software solution available with a free opensource as well as a private commercial license. It can easily be deployed as stand-alone on-premise installation or delivered as a hosted application.
• The open source and free-to-download application OpenQMS.net is a lightweight, scalable and cloud-native Quality Management System that is designed and built to meet biopharmaceutical quality standards such as GXP, FDA Part 11, and EMA Annex 11 .

Structure and Background

C-realize was founded in 2017 by current CEO Hao Wang, who decided to build on his long experience as  a regulatory compliance consultant to top pharma companies to start an IT company serving the life sciences industries.

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

Over the years since, 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 development of opensource QMS software as an off-the-shelf application, launched in 2022, represent a major milestone in C-realize product development.

Quality, Regulatory and Standards

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 IT regulatory 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.

It uses its own proprietary Software Development Lifecycle based on GAMP to regulate and ensure its own internal Quality Management System. The customer QMS product, based on the same platform, is lightweight, cloud-native and scalable. Based on Microsoft .NET framework, it can easily be integrated with Office365, Azure cloud and other Microsoft technologies. It is also available as a free open source license.

Booking Calendar

C-realize develops software following an agile and controlled development lifecycle based on industry best practices and regulatory standards. We help our customers build continues delivery pipelines to automate quality and compliant application development. To learn more please book in an Introductory Consultation Session.

C-realize validates new and legacy IT systems to comply with GXP, FDA Part11 and EMA Annex11 regulatory guidelines. We help our customers integrate and automate all phases of the software development life cycle delivering a validation package that meets the requirements of auditors and inspectors. To learn more please book in an Introductory Consultation Session.

Compliance is not achieved through a one-time validation but rather an ongoing process that needs to be continuously monitored and controlled in combination with a quality / information security management system. We have the people, tools and know-how to help you implement your own integrated management system in an efficient and cost-effective way tailored to your organization. To learn more please book in an Introductory Consultation Session.

An auditing service that benchmarks organizations and their partners/suppliers for the effective integrated management system which fosters patient safety, product quality and data integrity accompanied with personnel training adapted to your organization’s needs. To learn more please book in an Introductory Consultation Session.