CAPA Investigations

CAPA Investigations

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).

Most companies have recognized that how a quality system is maintained and monitored is critical to its effectiveness. Effective CAPA programs provide regulatory agencies confidence that an organization has the ability to self-identify non-compliant issues, identify root cause, determine appropriate corrective actions and ultimately implement these actions in a timely manner to prevent the re-occurrence of the non-compliance addressed.

  •  Do you have the right CAPA process in place?
  •  Can you determine how effective it is?
  •  What are the input and feeders to your CAPA system?
  •  Are you missing or leaving anyone out?
  •  What tools do you use to conduct your CAPA investigations?
  •  Are they appropriate?
Failure to establish a compliant and effective CAPA system will damage the progress your organization has made, and erode the confidence of the Agency or regulatory authority.

It may result in the loss of the ability of your organization to market products it manufactures worldwide. Do not let that happen to your organization. Having a robust CAPA system in place, fully implemented and sustainable, will build confidence with regulatory authorities.

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.

To discuss how Synergy Bioscience can help you, please contact us.

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