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.
Bluciela-Lifesciences SAS
The company will supply consultancy, interim work, assessments, audits and will grow by attracting associates and client Lifescience companies who require deep expertise in the Pharma and Biotech industry.