Industry: Pharmaceutical Products / Medicine

Quality Management Ensures the Reliable Control and Implementation of GxP requirements

The ConSense GxP software solution is perfectly tailored for companies from sectors, such as medicine, medical technology, pharmacy and health care: Besides support for integrated management systems based on ConSense IMS, ConSense GxP facilitates the implementation of/compliance with these guidelines for Good Practice. For example, ConSense GxP takes over the extremely time-consuming document management in the area of GxP.

Benefits and Functions

• Our solution helps you comply with standards and guidelines for Good Practice specified as part of quality management.
• Audit-proof archiving is mandatory: The solution supports the archiving of documents, processes, and changes as part of change management.
• GxP-compliant documentation and the seamless traceability of system changes is ensured via an audit trail with a history entry and can be quickly checked.
• As part of the system activities, electronic signatures in the definition provided in 21 CFR Part 11 for clear user recognition can be used at any time.
• Individual user rights management and the display of relevant information and data depending on the configured roles and rights enable a particularly high level of protection against unauthorized access.
• Validation can take place in cooperation with ConSense GmbH.

Standards and Guidelines:

• Directive 93/42/EEC for Medical Devices,
• MEDDEV-EU papers for medical devices
• EudraLex GMP Guideline Vol. 4 Annex 11 for computerized systems
• FDA Guideline Title 21 CFR Part 11 for electronic records
• Electronic signatures, MPG, DIN EN ISO 13485, etc.