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Regulatory Compliance

We support companies to ensure their products are safe for use

If you require expert assistance in establishing and implementing a business model for Quality, Validation, and Compliance, or need help executing and managing such projects, our Regulatory Compliance consultants are ready to exceed your expectations with lean, scalable, and risk-based solutions.

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Discover our Regulatory Compliance solutions

That's why Cegeka developed GxP Compliance Services

Our offerings enable clients to achieve and maintain their regulatory compliance objectives by providing a range of services in multidisciplinary environments like IT, Compliance, Risk, QA, and other.

Enhancement of Process of Supplier Approval/Rejection

Cost Savings due to Process Improvements and Standardization

Successful FDA and EU Inspections

Minimization of Risks such as Data Loss or Corrupted Data

Compliance with GaMP 5 Expectations and Guidelines

Delivery of Ready-to-Use, Correct, Secure and Compliant Spreadsheets

Significant Reduction of Validation Time Effort and Cost

Introducing Cegeka's

GxP Services

Patient safety is paramount when performing clinical studies or using pharmaceutical products or medical devices. By applying Good Practices (GxP) quality guidelines and regulations, companies within the healthcare and life sciences industries can ensure their products are safe to use.

Cegeka's approach to GxP compliance

To accommodate your organization to meet GxP compliance, we offer a variety of GxP Compliance Services. These 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 entire system

Risk based
Scalable
Lean
Successful FDA and EU inspections
Significant reduction of validation time, effort and cost
On-call assistance during inspections

ERP/SAP Validation

Leverages ERP/SAP knowledge and documentation to enhance validation

Excellent Baseline based on SAP specific supporting processes
Successful FDA and EU inspections
Significant reduction of validation time, effort and cost
On-call assistance during 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

Successful FDA and EU inspections
Ready-to-use, correct, secure and compliant spreadsheets
No validation effort is required from your part

Quality Coaching as a Service

Offers immediate assistance to address specific GxP and/or ISO 27001 related requests

GxP / ISO 27001 helpdesk

Training and Coaching

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

Vendor Audit

Identifies 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

Our partner network is built to combine today’s leading technologies with our IT solutions and services to accelerate our clients’ transformation initiatives

Given the accelerated pace at which new technologies emerge and the specialized and evolving needs of our clients, it’s essential that we leverage industry partnerships to amplify the value we provide to clients.

Our strong partner network provides clients with even greater speed, adaptability, and confidence that their IT and digital transformation initiatives will be powered by the technologies, skills, methodologies, and industry experience necessary to achieve their desired business, technology, and operational outcomes.