Operational Excellence
Sustainable Improvements
Understanding and analyzing the existing business processes of organizations is a precursor to implementing viable change and enhancing performance. Our goal is to work with our clients to achieve their business objectives through sustainable improvements.
Sustainable Improvements
Understanding and analyzing the existing business processes of organizations is a precursor to implementing viable change and enhancing performance. Our goal is to work with our clients to achieve their business objectives through sustainable improvements.
Relevant Expertise
Our consultants have experience that range from simple redesign of a single process in a single functional area to complex reengineering of all strategic, value-added processes within the organization. Our breadth of expertise with a wide variety of improvement tools ensures that the improvement efforts are solution-focused to attain our clients’ individual needs. We assist our clients in successfully managing and sustaining practices, processes and/or technology changes. Our consultants have effective relational and communication abilities to really empathize with our patrons and reduce their anxiety for change.
Relevant Expertise
Our consultants have experience that range from simple redesign of a single process in a single functional area to complex reengineering of all strategic, value-added processes within the organization. Our breadth of expertise with a wide variety of improvement tools ensures that the improvement efforts are solution-focused to attain our clients’ individual needs. We assist our clients in successfully managing and sustaining practices, processes and/or technology changes. Our consultants have effective relational and communication abilities to really empathize with our patrons and reduce their anxiety for change.
What Gets Measured, Gets Done
We support our clients to achieve successful outcomes by providing services that assist their organization in developing frameworks and metrics, planning, and delivering operational efficiencies and excellence.
What Gets Measured, Gets Done
We support our clients to achieve successful outcomes by providing services that assist their organization in developing frameworks and metrics, planning, and delivering operational efficiencies and excellence.
Case Studies
Deviation Management
After dealing with ongoing compliance issues, our global pharmaceutical client retained the services of Brevitas to provide strong leadership and project management support in managing and improving their deviation management quality system.
OSE Preparation
An international client required support to address recent findings from an FDA inspection and prepare for an On-Site Evaluation (OSE) by the Biologics & Genetic Therapies Directorate (BGTD). Brevitas provided GMP advice and coaching which facilitated the successful execution of the OSE, with no observations.
Production Backlog
In order to meet increasing demands for their product, our global pharmaceutical client retained the services of the Brevitas consultants to provide project management leadership to resolve resource constraints, scheduling backlogs, and compliance issues.
Quality Notification Management
In order to meet the constant demand for their products, our Global Pharmaceutical client retained the services of Brevitas consultants to provide compliance support and address open Quality Notifications by special investigation and effective root cause corrective actions.
SOP Consolidation
Brevitas consultants provided technical and compliance expertise to a leading Canadian pharmaceutical company for the revision and creation of global GMP, GLP and GCP Standard Operating Procedures (SOPs). Within 5 months, the number of global R&D SOPs was reduced from 100 to 50, to help achieve lean operations.
Criticality Assessment
Our client required an approach to categorize critical utility system components, to allow for the adjustment of maintenance frequencies and verify the accuracy of information within SAP. Brevitas developed a standardized assessment method and successfully applied it to 30 critical utility systems across the site.
