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.