Remediation

Warren Buffet said it best. In other words, ensure your systems are robust enough to prevent the need for remediation.

Even the best companies can encounter problems. Remediation efforts can be painful and distract the entire organization from your true objectives. Innovision can help reduce that pain.

Audits and Potential Warning Letters

Innovision has experience working on remediation of warning letters, including helping organizations prepare for and execute, audits.

CAPA Backlogs

Innovision has extensive experience in working through CAPA backlogs. We work on specific CAPAs as well as provide guidance for how to efficiently execute them. We have helped organizations create their CAPA systems to be compliant with regulations and to efficiently keep current with their CAPA timelines.

Documentation/Design Controls

Innovision has a strong expertise in Design Controls, particularly in remediating organization’s deficiencies with regards to FDA regulations. Innovision’s strategy is to integrate the Design Controls with the Product Development System to ensure all requirements are met as a matter of practice,