C-realize works as an IT partner for the pharmaceutical, biotechnology, and medical device sectors, providing software development, Cloud computing services, and regulatory compliance advice and solutions. We primarily work with small and medium-sized biopharmaceutical and medical device companies, as well as life science-focused software vendors, to help them digitalise, streamline, and automate their processes.
C-realize can construct digital quality management systems (QMS) that are integrated with Cloud-native technologies, as well as providing computer systems validation and IT infrastructure qualification for FDA Part 11, EMA Annex 11, and other regulatory compliance. Our aim is to help clients transition to Pharma 4.0 while meeting industry standards and complying with regulatory criteria.
Life science software design, development and testing
C-realize’s core capabilities are in designing, developing, and testing software for the life science industry, as well as computer system validation and secure compliant cloud computing. We focus on the specific business and regulatory demands of the life science market, including patient safety, product quality, and data integrity.
We draw on our abilities to offer four main services:
- Agile software development and testing: C-realize develops software following an agile and controlled software development life cycle that is based on industry best practices and regulatory standards.
- Computer systems validation (CSV): Validating new and legacy IT systems to comply with FDA Part 11 and/or EMA Annex 11 regulatory guidelines, supporting clients through all phases of the development life cycle, and constructing a validation package that meets the requirements of auditors and
- 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 or information security management system.
- auditing and training: C-realize offers an auditing service that benchmarks organisations and their suppliers for quality and information security It can be accompanied with personnel training adapted to client organisation needs.
Cloud and QMS services for the life science industry
In addition to our core services, C-realize provides a range of IT services and products based on our skills in agile software development and an awareness of our clients’ specific needs. These include Cloud services and solutions and Cloud-native microservices, as well as an end-to-end QMS software solution that is available with a free open source license.
OpenQMS.net is a lightweight, scalable, Cloud-native Quality Management System that is designed and built to meet biopharmaceutical quality standards such as Good Manufacturing Practice (GMP), FDA Part 11, and EMA Annex 11.
Pharmaceutical quality, regulatory and standardisation testing
C-realize holds certification in computer validation management by the European Compliance Academy and is a member of the ISPE International Society for Pharmaceutical Engineering. Our products meet all requirements of the life science industry’s IT regulatory and quality standards, including GxP regulations, Part 11 of Title 21 of the Code of Federal Regulations, Electronic Records and Electronic Signatures (21 CFR Part 11), EU GMP Annex 11: Computerised Systems (Annex 11), ISO 9001, and ISO 27001.
C-realize follows its own proprietary software development lifecycle, which is based on good automated manufacturing practice (GAMP).Our QMS product is designed to be lightweight, Cloud-native, and scalable. Based on Microsoft’s .NET framework, it can easily be integrated with Office365, Azure Cloud and other Microsoft technologies. It is also available with a free open-source licence.
C-realize was founded in 2017 by its current CEO Hao Wang, who has long served as a regulatory compliance consultant to various top pharmaceutical companies. The company’s location in Cluj-Napoca, Romania, takes advantage of the area’s status as a recognised technology hub for south-east Europe.
Since its establishment, C-realize has experienced rapid and continuous growth, assisted by its advantages in providing fast responses, a single point of contact, and deep experience in computer systems validation and secure compliant cloud computing for the life science industry.