As the vaccines division of one of the world’s largest pharmaceutical companies, Sanofi Pasteur has compliance requirements that span a variety of regulatory agencies and cover everything from air, water, and waste to vaccine sampling by the Food and Drug Administration (FDA). When the organization began its search for a compliance management system, they were looking for a solution to ease the burden on the compliance staff, without requiring additional support from the Information Solutions (IS) department.
Sanofi Pasteur selected the Enviance System based on its Internet platform, and ability to handle tasks, calculations, and reporting for multiple regulatory agencies. Data only needs to be entered once, and is manipulated to fit all of the organization’s requirements:
- Title V
- Discharge Monitoring Report (DMR)
- Infectious and hazardous waste tracking
- FDA’s current Good Manufacturing Practice (cGMP)
- Sustainability and annual shareholder reporting
- Green reporting in Canada
Because the organization had limited personnel resources in the environmental, health and safety (EHS) department, Sanofi Pasteur began looking at compliance management systems to streamline processes, improve data quality, and save time. The Enviance System was initially used to automate fuel permit calculations on an hourly basis.
- Enviance has allowed the organization to automate these calculations and provides a host of other applications
- Compliance calendar to ensure tasks are completed
- Easy manipulation of data – enter once for multiple requirements and eliminate redundancy
- Integration with an onsite data system – Prodigy Historian
- Data management across the board – air, water, waste, and recycling
Security was a concern for sanofi pasteur, because they wanted to manage a large amount of compliance data with an Internet-based solution. The Enviance System is safeguarded by multiple layers of security, and data backups are done every day.
The internal IS team performed an audit of Enviance’s protocols and procedures before deciding that it was the right solution. The Enviance System met their security criteria, and even made their jobs easier because all data is now securely hosted by Enviance and stored offsite.
New and innovative strategies are being used to make infectious and hazardous waste tracking easier and more precise. Sanofi Pasteur is using Personal Data Assistants (PDAs) to scan bar codes on waste containers. They are tracked from the research bench, to the truck, to the incinerator. This has automated the tracking process, and as opposed to spreadsheets and checklists, has greatly improved the accuracy of data.
Rather than implement a variety of systems to manage compliance requirements, Sanofi Pasteur selected the Enviance System as their compliance solution of choice – thereby maximizing value and improving the quality of their data.