C-realize Auditing & Training for IT quality and data security

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.

This Quality and Security Auditing and Training solution includes a thorough systems audit and, where necessary, workforce training adapted to organizational needs.

Meeting quality and data integrity standards  

The core C-realize mission is to help companies in the life sciences sector comply with the patient safety, product quality and data integrity standards that apply throughout the industry.

In today’s increasingly connected world, life sciences companies need to ensure that they are meeting the latest standards and regulations and that their partners and suppliers are also meeting.  This need is becoming ever more acute amid increasing concerns about global supply chain integrity and as the Pharma 4.0 transformation places even more load on information systems and secure data networks.

The current trend towards Software as a Service (SaaS) cloud-based solutions that allow pharma companies effectively to outsource their IT systems and operations is a two-edged sword. While it allows client companies to tap into the latest technologies while focusing on their core businesses, it also poses risks. There’s little assurance that the chosen SaaS provider will observe the same demanding quality and data integrity standards for computer systems validation and compliance demanded by pharma industry regulators.

End-to-end solution

The C-realize Auditing & Training service offers an end-to-end solution to information integrity and security needs by combining its core strengths. One is deep expertise in pharmaceutical QMS quality management systems, dealing with QA managers at various world-leading life science companies as well as institutional auditors. Another is hands-on experience in modern agile software development and access to the latest cloud technologies.

The Auding & Training service is tailored to individual customer needs, ranging from the startup medical device company new to GXP regulations, through seasoned biopharmaceutical companies striving to keep up with the pace of digitalization while maintaining compliance, to IT service providers that need to understand and comply with the requirements of pharma industry customers.

Therefore, objectives, scope, and deliverables will vary from project to project but all C-realize Auditing & Training engagements are characterized by a pragmatic approach, commitment to delivery on promise, competitive pricing and a cost efficient focus on assured quality, regulatory compliance and reliable ongoing support.

Furthermore, all projects are led by C-realize founder and CEO Hao Wang, calling on his more than 15 years’ experience in quality and regulatory compliance serving various world leading as well as smaller/medium-sized companies in the life science industries.

The C-realize commitment to measurable added value results in a service that delivers quantifiable user benefits. These include:

• Value for money
• Increased confidence and trust among customers, partners, and regulatory authorities
• Greater ease in meeting regulatory and compliance requirements
• Assured data integrity and accessibility
• Seamless exchange of information
• Enhanced competitiveness through streamlined, automated, paperless processes

Resources

Click on C-realize Auditing and Training to book a consultation.

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.