Chicago Controls can identify regulatory issues in the design stage which allows corrections to be implemented prior to the construction, conserving project schedule and budget and allowing for FDA approval upon completion.
To identify and remediate issues which may arise during an FDA review, Chicago Controls provides the following regulatory compliance audit services and develops action plans:
- 21 CFR, Part 11 Compliance Evaluation
- Gap Analysis
- FDA Communications/Action Plan
- Remediation Plan Development
Chicago Controls can conduct an audit of existing facilities prior to FDA inspection which will allow resolving of regulatory issues ahead of FDA’s arrival. In addition, where citations have been issued by FDA, Chicago Controls can support development of the response that includes the required corrective actions and the implementation plan.