CAPAS

Recurring Manufacturing and Quality Issues?

Recurring manufacturing and quality problems can be frustrating when lean run operations lack the resources to address them, or internal teams develop tunnel vision. We can bring an independent perspective and augment your troubleshooting team. We have process experts who can lead investigations to determine the root cause, using an array of investigation tools. We can develop CAPAS and support implementation.

Backlog of CAPAS and Change Controls?

CAPAS and Change Controls are continuously created in pharmaceutical operations and are an integral part of quality management systems. Whether it be from product complaints or manufacturing operations, CAPA volumes can fluctuate. When the volume stretches the internal resources of a company, it is easy to fall behind. Failing to close out CAPAS and change controls can have dire consequences with regulatory agencies and other stakeholders. We can clear out the backlog and help you meet your compliance goals.