Maetrics One Sheet Overview1 4
- 1. LEAN CompLiANCE. QuALity. tEChNoLogy. Medical Device, Pharmaceutical, Nutritional, Biotech, and Healthcare environments are subject to continuous regulatory changes. Helping you manage your business within these environments is our sole focus. Since 1984, Maetrics™ has been delivering a wealth of experience to many of the leading companies in the Life Sciences industry including Pharmaceutical, Medical Device, Biotech, Cell Therapy, and Nutritionals companies. Call or click today to find out how we can help you achieve Lean Compliance with the following services: REguLAtoRy SERViCES • Regulatory strategies We believe in lean. • FDA “mock” inspections for GMP, GLP, & GCP environments We deliver lean ComplianCe • Audits, assessments, & remediation • Responses & submissions to regulatory agencies solutions that Combine lean • Preparing for & remediation after regulatory inspections manufaCturing, six sigma, • Review and pre-approval inspections • Program and project management methodologies, tools, and industry best praCtiCes to QuALity SyStEmS • Audits, assessments & implementations solve nearly any regulatory, • Implementing, improving, or centralizing a quality wystem quality, validation, or engineer- • Supplier management, vendor/supplier audits • Risk management, CAPA, & complaints ing Challenge. We routinely • ISO certification assistance & training utilize these exClusive • Quality system documentation Capabilities to deliver on VALiDAtioN • Risk Based Validation Systems including Master Plans Consulting engagements that • Validation policies & procedures Can vary from a feW hours of • Computer systems & software validation • Part 11 Assessment & remediation expert adviCe to a large sCale • Manufacturing processes, equipment, facilities, & systems multifaCeted projeCt team • Laboratory systems, methods, & equipment • Clinical systems & equipment involving more than 50 people. • Facilities, utilities, aseptic/sterile operations • Commissioning & qualifying new facilities • Change control systems SoFtWARE tooLS Compliance and quality dashboards and scorecards with Theoris Vision Software™ tRAiNiNg Custom regulatory and technical training including: GMP, GLP, GCP, QSR, QSIT, validation, quality systems, software and other custom training solutions ™ www.maetrics.com | 877.MAETRICS (623.8742) | © Maetrics, LLC 2011 Compliance. Quality. Technology.