usdatamanagement.com

Let USDM's established Quality Assurance & Global Auditing practice provide life sciences industry experienced, certified auditors with hands-on operating experience assist you in assessing and ensuring the adequacy, effectiveness and current state of compliance of your GxP critical operations.

Auditor certifications include American Society for Certified Quality Quality Auditors (CQA), Registrar Accreditation Board (RAB) and QSA International Quality Management Systems certifications and Software Engineering Institute (SEI) Capability Maturity Model Integrated (CMMI) certified appraisors.  

Specialized Auditing expertise includes;

• auditors with experience auditing pharmaceutical manufacturing, packaging, clincal labeling and global distribution/logistics operations throughout the US, Latin America, EMEA, India and rest of world (ROW).
• solid & liquid dose aseptic/sterile finished pharmaceutical manufacturing, biotechnology and medical device operations
• Cleaning validation programs including a risk-based approach based upon worst case model compounds, total equipment surface area and number of difficult to clean areas
• Class 10,000 and 100,000 clean room design and operation, monitoring and alarm systems including temperature, humidity, differential pressure, particle count and HEPA filter testing/certification program evaluations
• Assessments of environmental monitoring programs, facility contamination control and methods to maintain microbiological standards including a monogram for non-sterile facilities
• Batch records compliance including start-up, in-process and final checks including final product release
• Quality Management Systems including trending and correction of chronic/systemic issues and evaluation of effectiveness of corrective and preventive action (CAPA) systems
• Quality Unit effectiveness
• Investigation Medicinal Product (IMP) manufacturing, packaging, labeling & distribution
• Pre-Approval Inspection (PAI) audits to determine state of readiness and enhance probability of FDA approval
• 21 CFR parts 58, 210, 211, 820 and EMEA EU Guidelines
• Facility security including physical and logical security and vunerability assessments
• DEA Controlled substance and high value product security controls assessments including cycle counting, inventory leakage and potential threats due to loss or diversion
• IT network infrastructure qualification and vulnerability assessments
• SOX COBIT critical control elements and segregation-of-duties
• equipment, facilities and process validation programs
• computer systems development life cycle management and validation programs
• laboratory instrument lifecycle management systems including procurement, installation, qualification/validation, commissioning, maintenance/repair and decommisioning
• An FDA QSIT systems approach to Manufacturing, Quality, Distribution/logistics, Training/Qualification, Customer Service Systems audit
• FDA, DEA and MHRA based audit approaches
• Performance based auditing rather than traditional paper-based audits