Should your organization find itself responding to a Warning Letter or Consent Decree, Synergy Bioscience will develop a robust CAPA Process and train your staff on how to effectively implement it. Successful implementation of this CAPA plan will allow your organization to move forward with continuous improvement activities — and then eventual exit from the decree. Synergy Bioscience has a proven track record of success to establish, maintain, and train your organization on robust and effective CAPA processes that will keep business compliant. Therefore, you won’t have to worry about incoming FDA inspections and you can continue to focus on your core business bottom line.
A CAPA system is not only a regulatory requirement; it makes good-business sense to pharmaceutical and other life science companies. An effective CAPA process is capable of feeding the other processes of your Quality System to improve its processes, procedures, organization, and the overall business in a structured, well-documented and actionable manner. There is a strong link between Quality and Operational Excellence, as a well-established CAPA system, most often results in a high ROI and benefits for the business including:
- Improved patient safety
- Improved customer satisfaction
- Increased productivity, (as a less intuitive process might require more personnel)
- Infrastructure efficiency gains
- Better product quality, and
- Avoidance cost of regulatory non-compliance (fines, business closure, reputation and brand damage).