GLP – At QAC we can provide your company with comprehensive GLP services including: Standard Operating Procedure development specifically for your laboratory under 21 CFR Part 58 to assure regulatory compliance. We also provide review of your current documents for regulatory compliance. Gap Analysis to determine if your non-GLP laboratory is prepared to become GLP compliant. We can also provide an implementation plan to get your laboratory to GLP compliance. We perform GLP auditing to 21 CFR Part 58 and your internal SOPs. These audits include protocol audits, facility audits, in-life study audits, procedural audits, draft and final report audits, archival audits, and mock inspections. We can provide remediation of FDA 483 or warning letter for GLP facilities. We offer GLP training, Corrective Action and Preventive Action (CAPA) responses, Root cause analysis, protocol development, equipment validation protocols and master validation plans all specific to your needs.
GCP – At QAC we offer a full menu of GCP compliance services including: Review of your SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations. This includes SOPs for: Clinical trial management, Protocol and amendment development and deviation procedures, Investigator selection, Investigational product management, Subject randomization, Clinical monitoring (including centralized, remote, and risk-based on-site monitoring procedures), Data management, AE/SAE reporting, IRB communication, Regulatory submission, TMF organization and management, Records management and archival, Disaster recovery. SOP creation and maintenance for your organization in compliance with GCP regulations.
QAC can offer you contract Quality Management services for your cGMP facility. We offer the following Quality Management services: • QA/Quality Control Staff Augmentation • Policy, SOP & Batch Record Review, Preparation & Optimization including gap analysis for regulatory and international standards • Quality System (QS) Development, Assessment & Optimization • Root Cause Investigations & Corrective & Preventive Action (CAPA) Planning & Execution • Training – FDA, cGMP, QSR, DQSA, USP , USP , Method Validation, Cleaning Validation, Master Validation plans, Root Cause Analysis, FMEA and Risk Analysis • Third-party cGMP Compliance Auditing • Mock FDA/International Regulatory Agency Inspections • Due Diligence Compliance Inspections, Audits & Assistance • FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation • Risk Analysis of facility and/or processes • 510(k) development and submission Facility Commissioning Services: • Developing and executing commissioning plans that support the overall project schedule • Developing commissioning documents (e.g., User Requirement Specification, inspection forms, Factory Acceptance Tests and Site Acceptance Tests) • Inspecting for physical completion • Vendor audits • Witnessing vendor commissioning activities • Managing the commissioning activities of vendors, construction contractors, owners, and contract resources • Executing commissioning activities for utility and process equipment systems in a manner that maximizes opportunities for leveraging with qualification activities. Validation Services (development and auditing of): • FDA Process Validation • Process Performance Qualification (PPQ) • Guidance for Industry Process Validation General Principles & Practices • Process Validation Guidelines • Equipment Validation procedures and/or audits (IQ, OQ, and PQ) • cGMP Process Validation • Cleaning Validation
ISO standards – At QAC we offer the expertise in ISO 9001, ISO 14001 and ISO 13485. ISO has updated ISO 9001 and 14001 in September 2015 and have published the final draft of ISO 13485. Companies currently certified with ISO 9001:2008 and ISO 14001:2003 have until the end of 2018 to implement the changes in versions ISO 9001:2015 and ISO 14001:2015. We know your Quality Manager is busy with day-to-day tasks. Let QAC help with your Gap analysis and implementation plan for these standards while allowing your staff to focus on current product/service quality. We are currently working on developing Gap analysis and documentation to aid you in the conversion of ISO 13485:2012 to ISO 13485:2016. If your company is exploring ISO 9001 and/or ISO 14001 QAC can help you develop your implementation plan and provide document creation for either of these standards for the 2015 versions. The new versions of ISO 9001 and 14001 have placed an emphasis on Risk Analysis and eliminated preventive action. Let our experts train your
facility on Risk Analysis procedures such as Failure Mode Effective Analysis, Cause and Effect Analysis, and Value stream mapping.