There's no question that companies in the pharmaceutical industry, from global corporations to emerging start-ups, are constantly looking to get leaner without sacrificing any of their technical resources or core competencies. In order to accomplish this, they will leverage more contract manufacturing organizations (CMOs). Although the affordances of this strategy will often outweigh the constraints, there are some serious issues that can arise from outsourcing. These include lapses and disorganization of communications, data security, accountability and quality assurance.
Stratas was developed for TrackWise as a tool for supplier quality management to prevent these serious issues from occurring. It is a customer supplier portal that is used to manage and maintain the Approved Supplier List (ASL), determine supplier risk, and track and manage supplier quality workflows.
On March 10, 2015, Sparta Systems released an updated version of Stratas, which focuses specifically on the complex problems pharmaceutical companies have when working with CMOs with special attention paid to customer complaints and non-conformances. Customers who create an account will be able to access the web portal anywhere through the web and have the opportunity to connect with multiple suppliers.
The end result of the improved Stratas product will be increased traceability, improved security, decreased risk, and better communication
One of the areas in supplier quality management the updated Stratas addresses is the facilitation of CMO customer complaints. Pharmaceutical and Device companies that market products manufactured, in part or total, by contract agencies must have their issues resolved quickly and efficiently in order to ensure that the problem doesn't arise again. Stratas accomplishes this by managing all communications on one platform, negating the need for extra emails, phone calls, PDF files, and other manual methods in addressing customer complaints. All communications are encrypted to ensure security and industry compliance.
Customers who use Stratas to address complaints can create a set of investigations to identify the root cause for the complaint. From there, a corrective and preventive action (CAPA) can be established to resolve the complaint and an effectiveness check to ensure that the CAPA was followed and worked. Each step of the process, as well as any action and communication can be traced and assessed to make sure the complaint is being addressed in the most efficient manner possible. This helps to eliminate questions of culpability and helps pharmaceutical companies and CMOs to better manage customer complaints.
Another area that the new release of Stratas will address is non-conformances. Non-conformances are deviations occurring during the manufacturing process. Common non-conformances could include product discoloration, extraneous matter or purity, to name a few.
As with customer complaints, Stratas will help drug companies and their CMOs find solutions to quality issues and reduce risks by creating a single platform to report non-conformances, initiate investigations, report results and issue CAPAs directly from their TrackWise system. Drug companies and CMOs will be better able to track and manage all quality events from TrackWise using this newly revised cloud-based supplier portal.
To learn more about how Stratas works, please review our Stratas Supplier Quality Management page that features detailed product summaries, case studies, additional blog posts on Stratas, white papers and more.