Consent Decree? Warning Letter? Findings? – Recovery Support
As industry regulations continue to increase, it is not uncommon for an organisation to find themselves on the wrong side of an audit outcome with findings and observations to be addressed.
Remediation of a quality system is a complex and time-consuming task.
To achieve remediation an organisation may need to ask themselves some very tough questions:
- Is our risk management process operational and fit for purpose?
- Do we operate in silos or are we appropriately integrated?
- Are we a data driven organisation?
- Do we have the required data to support legacy products?
Very often audit findings are the first step to uncovering the systemic root causes that led to the non-compliance. Framing a remediation programme and drawing clear lines of scope is not an easy task. Remediation is a cross functional, multi-departmental responsibility that requires leadership support from the organisation.
Our team at Explic8 Limited have over 80 years’ joint experience in the medical device and pharmaceutical industries.
We specialise in supporting our clients with their varying remediation needs:
- Remediation execution strategy
- Remediation programme governance design
- Remediation programme management
- Remediation technical and compliance support
- Remediation communication with regulatory bodies
- Remediation communication to the executive team
We have helped our clients to complete significant remediation programmes including the management of 483s and communication to the FDA.
Key areas where we have supported clients:
- Process & Equipment Validation
- Test Method Validation
- Quality Systems
- Design Controls
- Handling, Labelling & Identification
- Document Control
- Non-Conforming Product
- Corrective & Preventive Action