A core expertise of the TCG team is remediation support and activities. Whether the needs are proactive to enhance an existing system or time sensitive in response to a Warning Letter or other enforcement action; TCG can rapidly mobilize a team of experts appropriate to manage the task at hand. Our approach is a holistic response to enforcement actions ensuring that your response and CAPAs are comprehensive.
Support starts with the remediation plan - development and implementation whether it be all or selected quality sub-systems, enterprise-wide or within selected facilities. Throughout the process we actively collaborate with our clients, which is necessary for a successful adoption and integration of sustainable solutions. Typical systems that are remediated include: OOS/CAPA system – certification, laboratory control, production control, computerized systems – access controls, and remediation plans development and execution.
We strongly feel that a Simple, Efficient and Compliant Quality System are not a means to compliance, but make good business sense. Quality Systems that we have remediated and/or implemented have shown a marked reduction in scrap, rework, rejected materials, repeat deviations, Field Alerts and Recalls. These benefits far outweigh the cost of implementing a robust Quality System.
A successful remediation effort begins with ensuring that a robust and strategic foundation is implemented through a plan. TCG works hand in hand with the client to develop and execute a remediation plan for all or selected Quality sub-systems. The plan is then strategically implemented enterprise-wide or to selected facilites.
TCG can provide remedial support to a number of areas including, but not limited to:
TCG provides key project management oversight on remediation efforts to ensure all aspects stay on schedule and that deliverables are achieved within a timely manner. The project manager tracks applicable regulatory commitments along with other Quality System remediation efforts as part of the remediation program. They monitor ongoing remediation activities and additional items that may emerge from existing Quality System remediation activities such as: Investigations, CAPAs, etc.;
therefore ensuring that these activities are accounted for and incorporated into the remediation effort.