GeminiBio understands the importance of our suppliers as we manufacture products for our end-customers. We have a rigorous Supplier Management program to approve suppliers based on their criticality impacting the manufactured final product. For high-risk suppliers, successful audits are required to receive full qualification as an Approved Supplier, and Quality Agreements or Change Notification Agreements are required to ensure we are able to secure transparency in our supply chain. Additionally, these audits help ensure that the goods and services that are obtained meet the requirements needed by our customers when our products are used within their workflows.
GeminiBio has internal procedures to manage Change Controls. All operational changes within GeminiBio are governed by Change Management. The Change Management process considers all stakeholders impacted by the change, and the considerations needed to be addressed for the change. This can include Change Notification Agreements or Quality Agreements with customers or suppliers, or potentially customers that have purchased the product or service in recent history.
The Change Control process ensures that proper implementation is documented and controlled through the use of pre-implementation and post-implementation objective evidence, as well as control mechanisms that prevent the change from occurring without final approval.
GeminiBio has an Internal Audit program, that is governed under ISO 13485:2016. This program reviews all required sections against the procedures performed under various departments and is performed annually. GeminiBio’s internal auditors are certified and trained to ISO 13485:2016 as lead auditors and are trained to ISO 14971 and ISO 9001.
GeminiBio welcomes all customer audits and can support on-site audits throughout the year.
In addition to audits, GeminiBio maintains a supplier monitoring program. This includes periodic reviews of our suppliers to evaluate the recent performance in areas such as: On-Time Delivery, supplier Corrective Action Reports, and any changes to the business or relationships.