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.
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
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.
Assistance for compliance with quality management standards, e.g. ISO 13485, and guidelines for good practice.
The implementation and activation of new processes take place according to a defined workflow.
The audit-proof archiving of documents, processes and changes in the course of change management is supported.
Electronic signatures as defined in 21 CFR Part 11 can be used for system activities.
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.
GxP-compliant documentation and complete traceability of system changes are realized by history entries via audit trail.
Overview of the level of competence of employees at the current time or in the past.
The validation can take place in cooperation with ConSense GmbH.
It is possible to compare database configurations.