ConSense GxP – Validation Management

Security through GxP 

The complex national and international guidelines for "good practice" (GxP), e.g. GMP, GCP, GDP, GLP, present companies with challenging tasks, for example from the medical sector, medical technology, pharmaceutical, health care and various other sectors, such as the food industry, logistics or the energy sector. At the same time, they must often comply with national or international standards, laws and guidelines for medical devices, such as Directive 93/42/EEC, the MEDDEV-EU Papers, the EudraLex GMP Guideline Vol. 4 Annex 11 for computer-aided systems or the US FDA Title 21 Part 11 Guideline.

Hard-understandable standards make an integrated management system almost imperative for all affected companies. Often there is also a need to validate the used software.

Support in complying with various national and international guidelines, laws and standards

The ConSense GxP software is perfectly adapted to companies in those strictly regulated industries. As an integrated management system, ConSense GxP facilitates the implementation and fulfilment of Good Practices guidelines. For example, it adopts more complex document management in the GxP area.

Based on the Integrated Management System, ConSense GxP supports compliance with various national and international guidelines, laws and standards with a variety of helpful functionalities

• Implementation and validation of processes and documents
• Electronic signatures
• Audit trail, complete traceability
• Access protection, dedicated role and rights concept
• Integration of online tests and trainings
• Skill profiles, overview of the status of employee qualifications
• and other functions

Our experts are happy to provide qualified and efficient assistance if the ConSense GxP software needs to be validated in a company.

The ConSense GxP software is not a medical device software within the meaning of Directive 93/42/EEC or according to the MEDDEV 2.1/6 product classification because it does not contain any therapeutic or diagnostic functions. The requirements of 21 CFR Part 11 are fulfilled on a voluntary basis, in the sense of a possible further development of the product from a regulatory point of view.

Advantages and functionalities 

Good Practice

Assistance for compliance with quality management standards, e.g. ISO 13485, and guidelines for good practice. 

Process Implementation

The implementation and activation of new processes take place according to a defined workflow.

Audit-proof Archiving

The audit-proof archiving of documents, processes and changes in the course of change management is supported. 

Electronic signature

Electronic signatures as defined in 21 CFR Part 11 can be used for system activities. 

Higher Access Protection 

Individual user rights management and display of relevant information and data, depending on the configured roles and rights, allow a particularly high level of protection against unauthorized access.

Audit Trail

GxP-compliant documentation and complete traceability of system changes are realized by history entries via audit trail. 

Employee Qualifications

Overview of the level of competence of employees at the current time or in the past.

Software Validation

The validation can take place in cooperation with ConSense GmbH. 

Configuration Management

It is possible to compare database configurations.