Launch date: 18th February 2019
Cost: To be announced
Available either as a standalone module or as an extension of cosmetri's Product Manager, the cosmetics GMP ISO:22176 module will be the first software application designed specifically for managing cosmetics good manufacturing practices.
Key features of the module include:
- internal auditing
- electronic document management for GMP
- issue management with CAPA required actions
- Out of Specification investigations
- SUE/UE case management
- supplier reviews
- SOPs and Working Instructions
- customer complaints
- KPIs for monitoring continual improvement of quality control processes.
Conduct regular internal GMP audits, with an overview of the level of completion. Compatible with most desktop and tablet devices, the auditor is free to perform their work on location, recording their observations and uploading any photographic records to the appropriate section of the audit. Problems pin-pointed by the auditor are managed through the creation of ‘Issues’. Enter a risk assessment for the Issue and invite any participants to collaborate in agreeing a corrective or preventive action - also known as a ‘CAPA’. A completed internal audit must be approved and signed off by the Head of Management. You’ll have a full history of all past audits and be able to demonstrate the continual improvements implemented by the company over time.
cosmetri’s GMP module provides the required framework for managing your company’s personnel, establishing clear chains of command and audit logging of key user activity. Role-based user management ensures a smooth transition when applying changes to staff. For example, if a new person takes over as Head of Production, all documents and Issues are automatically re-assigned to that user from their predecessor, without affecting past audit trails.
Any staff member can report a deviation by creating an Issue, which is escalated to the associated department’s manager.
cosmetri’s GMP module fulfils the ISO:22716 requirement for supplier reviews. Set the required supplier review cycle and view the status of each supplier. Materials purchased from suppliers which have an overdue or rejected review will not be available to manufacture when using the cosmetri Product Manager.
cosmetri’s electronic document management for GMP meets the requirements for ‘closed systems’, as defined in the EU’s EMEA Annex 11 and FDA’s Part 11. Full audit logs enable authorized personnel to verify who uploaded, approved or viewed any document. You’ll be warned if a key GMP document is missing and automatic review cycles can be set to ensure that files are kept up-to-date. A GMP document can be linked to an Internal Audit or an Issue – for example, if a revision is recommended as part of a corrective or preventive action (CAPA).
Keep your business compliant and ensure the maximum possible quality, safety and efficacy of your products. Sign up to our mailing list (see right) to be informed as soon as the module is released and to schedule a free online demonstration.