Staff Augmentation
Project-Based Activities
Quality Confidential provides contract staff augmentation for all Quality Management System (QMS) activities. Our consultants have provided enhanced staffing to small and large companies for the performance of root cause investigations; executed protocol review; executed batch record review; batch disposition; complaints assessments and processing; health hazard analysis activities; market action analysis; and document control activities. In addition, we have a select group of consultants that act as interim personnel for higher-level quality roles to ensure business continuity when key personnel are not available. Whether your company needs to staff a temporary project, requires extra assistance for remediation activities, or has to back-fill a position until the right candidate arrives, we have the right people, with the right skills, readily available for your project.
Person-In-Plant Activities
Quality Confidential is a proponent of real-time quality oversight for critical activities to ensure appropriate documentation and adherence to procedures. To this end, we offer Person-in-Plant (PIP) oversight for “critical to quality” steps in manufacturing processes. Quality Confidential consultants acting as PIP routinely coordinate document reviews and approvals between client and supplier, review documentation prior to approval for use, and review executed documentation real-time to ensure accuracy and completeness. Clients often request that we place a consultant (SME) on-site to observe first time manufacturing activities, process validation activities, clinical labeling, and packing and shipment activities for cold-chain assurance, amongst other activities.