Bluciela-Lifesciences SAS, retained Client Consultancy Service Program
Retained Client Consultancy Service Programs
Retained Client Consultancy Service Programs
This consultancy will offer Retained Client Consultancy Service Programs as listed below :
- Outsource your Audits/Supplier Management – paper, remote, on-site, 3rd party
- Ad hoc email inquiries & quick consultations
- Risk assessments – on request
- Organizational assessments
- Data Integrity Assessments
- Filing compliance gap assessments
- Critical Incident Management – on request
- Communication: Agreed meetings scheduled as required
- Assessments
- Deviation reviews
- Procedures
Management, strategy
- Out-source your costly internal activities while enduring operational excellence & efficiency
Organizational assessments
- Have an Organisation Fitness assessment to find out how well your organisation is working, procedures are simple and clear, staff adequately trained and educated.
Filing compliance gap assessments
- Check that your products being made in multiple locations are compliant with the filed process. Over the years & without comprehensive Change Control processes can drift causing non-compliance and potential recalls in one site or more.
- KPIs are they showing failing trends without corrective action? A detailed assessment looking for repeated failures, lack of root causes and poor CAPA.
Data management systems
- Ensure your paper systems are fully controlled, not photocopiable and reconcilable.
- Ensure your e-data is secure and fully controlled with
Access control
Secure Back-up and recovery
Time management
Audit trail - well designed - with critical changes visible
All critical e-data, validated CPPs, are collected, stored and trended
IT vendor assessments
- CSV audits of vendors
- Ensuring Quality Management System in place
- Software programming standards in place
Let the experts be available for you as & when you need them or let them manage your system for you.