QMS Compliance Consulting

At QMS Compliance Consulting, we pride ourselves in offering complete validation services compliant with FDA and EU regulations, amongst others. Our validation services include strategic planning based on current risk base approach for validation, commissioning and qualification activities. We have experts in regulatory compliance who understand FD... A, EU, ICH, sFDA and PICS requirements. Whether you are a highly experienced organization looking for skilled resources to supplement your own staff or you are a company looking for specific expertise in an area new to you, QMS can assist you. Our experienced staff can help you prepare for a pre-approval inspection (PAI), bring new facilities on line, bring products to commercial market, and meet your commitments to the regulators. We offer a full range of validation services including the following: Validation Master Plans (Developing a validation strategy for the organization) Validation Protocols / Reports / Field Execution Analytical Instrument Qualification Computerized System, IT Infrastructure and Software Validation Cleaning Cycle Development and Validation Factory Acceptance Testing Site Acceptance Testing Equipment Qualification Facility Qualification Process Validation Utility System Validation Shipping and Packaging Validation Test Method Validation Inspection Preparation: Life science companies are inspected by regulatory authorities for compliance with cGMP regulations. An inspection and its follow up activities require intensive preparations and absorb a significant portion of energy from the organization. Preparing for inspections and their follow-up requires an extremely focused approach and the knowledge of the latest inspection trends. QMS is specialized in the preparation, accompaniment of inspections by authorities and their respective follow-up, including the FDA. The following items will be assessed by QMS before inspections: Review of the quality system Review of the production plant, warehouses and laboratories Ensuring that all documents ...Read More