ConSense GxP Validation.
Reliable Compliance.
For organizations in highly regulated industries.
What Organizations in the GxP Environment Face.
How We Make It Work.
Fully Implement Regulatory Requirements
Regulations such as EudraLex Annex 11 or 21 CFR Part 11 are complex and require deep expertise. With GxP-compliant structures and personal support, ConSense ensures you always keep control.
Common Challenges
Companies must meet national and international regulations
Requirements are difficult to interpret and often ambiguous
GxP-compliant processes demand know-how and documented evidence
How ConSense Helps
Validation-ready management system with GxP-compliant structure
Features such as audit trail, electronic signatures, change tracking, and role-based access control
Personal support from an expert team for implementing regulatory requirements
Regulatory requirements demand compliant structures and solid expertise. ConSense gives you both.
- GxP
- Risk Management & ICS
- KPIs
Validate Efficiently and Prevent Deviations
Validating software according to GAMP5 or 21 CFR Part 11 is time- and resource-intensive. If internal capacity or experience is lacking, audits can result in findings. ConSense minimizes validation effort and helps prevent deviations. On request, we guide you through every phase of validation.
Common Challenges
Validation under GAMP5 or 21 CFR Part 11 is time-consuming
Internal resources or expertise are often insufficient
Risk of deviations and audit findings
How ConSense Helps
Validation-ready system including IQ/OQ support
Templates, checklists, and project consulting
Optional: Full validation support including planning, testing, and final documentation
Less effort, more security: ConSense makes validation processes resource-efficient and reliable.
- GxP
- Risk Management & ICS
- KPIs
- Audits
Document Every Detail
In a GxP-regulated environment, every detail counts. ConSense keeps you in control with a complete change history, a GxP-compliant audit trail, electronic signatures, and clear role and access management.
Common Challenges
Changes to documents or processes are not fully recorded
Audit trails and responsibilities are often unclear
Audits require complete change tracking
How ConSense Helps
GxP-compliant audit trail for all relevant system activities
Electronic signatures with user binding and timestamp
Clear role and rights management for transparent accountability
With ConSense, you have everything that matters in view: changes, roles, and permissions.
- GxP
- Risk Management & ICS
- KPIs
- Audits
Verify Employee Qualifications
Training alone is not enough. In the GxP environment, documented proof of qualification is mandatory. ConSense makes qualifications visible and traceable.
Common Challenges
Documented proof of training and qualification is essential in GxP
Lack of visibility into training status or qualification gaps
Missing training records lead to audit deviations
How ConSense Helps
Integration of online tests and training directly in the system
Competency profiles and training histories for all employees
Documented evidence available anytime – even for audits
With ConSense, you can easily prove qualifications: transparent in the system and reliable for every audit.
- Qualifications
- Training and eLearning
Remove Barriers. Ensure Compliance.
National and international guidelines for Good Practice (GxP) impose high demands on organisations. ConSense makes implementation easier.
Our software supports companies in highly regulated industries with GxP-compliant structures and features such as audit trail, role-based access management, automatic version control and controlled workflows for document creation, review and approval. In addition, we provide personal support for validating your system.
This creates a solid foundation for sustainable GxP compliance. You minimise risks, increase process security and build trust.
GxP Validation Management with ConSense:
Your Benefits
Your Product Advisor
- Get the right recommendation in just 3 minutes.
- Automated analysis of your input
- Instant results, ready to view and export as a PDF
ConSense Helps to Manage Complexity
In Three Steps to
Your New Management System
Always Well Advised
Our modular services
give you exactly the support you need when you need it.
