Document Preparation/Review
Review of
Technical Documentation & Protocols
Large validation projects, such as bringing new facilities online or transferring products between facilities, have tight timelines. Bottlenecks are common in the document processing steps for non-routine projects, as employees fit this work in with other full-time responsibilities. Quality Confidential can resolve difficulties by providing consultants or temporary staff to perform quality or technical reviews of protocols and executed documentation, as well as other document management system roles.
SOP Writing
Written policies and procedures are the backbone of every Quality Management System (QMS). Quality Confidential consultants are skilled in creating documents for the pharmaceutical and medical device industries that ensure compliance to regulatory and global standards. For each SOP written or revised by our consultants, a gap analysis against current applicable regulations and standards is performed to ensure 100% compliance for all requirements.
Review of Master
Batch Record Documentation
When preparing Master Batch Records for clinical or commercial production, or transfer of a product to a new site, companies must ensure that the new documentation adequately captures all critical steps and adheres completely to the process described in the CMC section of regulatory applications. Quality Confidential consultants perform comprehensive reviews and gap analyses of production documents against regulatory requirements and submissions.
Review of CAPA &
Root Cause Analysis Investigations
One of the most common deficiencies identified by regulatory agencies and other organizations is the failure to fully investigate deviations from established procedures, specifications, and manufacturing records. Quality Confidential has specialized consultants available to perform investigation reviews. Our consultants ensure that each investigation has been performed in accordance with company and regulatory requirements. Elements of a complete investigation include: identification of root cause, assessment of impact to the process(es) and all product, and determination of corrective and preventive actions with effectiveness check plans, as needed.