Enhancement of Process of Supplier Approval/Rejection
Successful FDA and EU Inspections
Compliance with GaMP 5 Expectations and Guidelines
Significant Reduction of Validation Time Effort and Cost
Cost Savings due to Process Improvements and Standardization
Minimization of Risks such as Data Loss or Corrupted Data
Delivery of Ready-to-Use, Correct, Secure, and Compliant Spreadsheets
INTRODUCING CTG’S
GxP Compliance 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.
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 help desk
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
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