GxP Services
Ensuring GxP Compliance for
Your IT Systems & Practices
With more than 20 years of experience in life sciences, Cegeka can provide value-added solutions to ensure the GxP compliance of your IT processes, systems and applications.
The main objective of GxP regulations is to ensure patient safety. Whether you are a start-up company in need of professional expertise to set up and implement a business model for Quality and Validation, or a big life sciences company in need of resources to execute and manage validation and compliance projects, Cegeka’s Regulatory Compliance is fully equipped to get the job done and satisfy your expectations.
Cegeka's approach to GxP compliance
Our services are based on lean, scalable, risk-based, and agile concepts, all following the latest standards in the market.
Computerized System Validation (CSV)
Ensures the validated state of your system
- Risk based
- Scalable
- Lean
- Significant reduction of validation time, effort and cost
- On-call assistance during inspections
- Successful FDA and EU inspections
CSV Supporting Agile Development Methods
Ensures the validated state of agile-developed applications
- Time and cost savings due to process improvements and standardization
- Meet GaMP 5 expectations
Spreadsheet Validation as a Service
Takes full ownership of the validation of your spreadsheets
- Ready-to-use, correct, secure and compliant spreadsheets
- Successful FDA and EU inspections
Quality Coaching as a Service
Offers immediate assistance to address specific GxP and/or ISO 27001 related requests
- GxP / ISO 27001 helpdesk
- Pay for performance
- Application of current and up-to-date GxP best practices
- Timely and duly response to requests
- Access to compliance experts to address all challenges that may be encountered during service execution
Training
Helps your organization get a better understanding of compliance topics
- Increase in effectiveness and efficiency
- High ROI
- Training that is tailored to your specific business needs
Coaching
Supports your validation and quality projects through coordination, management, and control
- Ensures compliance within the expected level of quality, time, and budget
- Increase in effectiveness and efficiency
Vendor Audit
Obtains a full compliance picture of your supplier by identifying the risks that can impact your business
- Enhancing process of supplier approval/rejection
- Audit Report to enable you to monitor the remediation effort with your supplier
Compliance Assessment and Remediation
Provides a detailed picture of compliance gaps and remediation measures
- An Assessment Report to enable monitoring of the remediation effort
- Ready-to-go Roadmap for Remediation
IT Infrastructure Qualification
Realizes a secure and easily maintainable IT infrastructure
- Increase of transparency and efficiency
- Cost savings due to process improvements and standardization
- Minimizes risks such as data loss, corrupted data to an acceptable level
Equipment Qualification
Qualifies a wide range of your laboratory equipment
- Experienced Subject Matter Experts on all types of equipment
- Deliver equipment that is qualified according to current best practices and regulatory requirements
- Free of charge after care within a year
Related content
ISO 27001 Information Security Services
Quality Coaching as a Service (QCoaaS)
Get in touch
Want more information about our GxP Services?
Fill in the contact form and our experts will help you as soon as possible.
5G, Artificial Intelligence and hybrid cloud: all breakthrough technologies in and by themselves. But their real potential?
Discover more
Solutions
Services
Industries
Careers
About Cegeka
Cegeka & Society
About us
Why Cegeka
Annual Report
Let's get in touch
Get more information about our services & solutions and discover how we can help you.
Privacy
Cookies
Terms & Conditions
Boilerplate
© Cegeka