FDA Readiness Toolkit

Quality standards are defined by governing entities in order to promote and sustain the quality of products manufactured
throughout the world. The guidelines set forth by regulatory agencies like the FDA are a major factor in ensuring
that companies manufacture and sell products that are safe, reliable, and effective. Complying with these regulatory
requirements is simply a part of doing business for many organizations. MasterControl, a global provider of enterprise
quality management software (EQMS), has invested over 380 expert hours into the creation of this FDA Readiness
Toolkit designed to help companies like yours simplify compliance with FDA standards by streamlining quality-related
processes.

FDA Readiness Toolkit Videos:

FDA Just Called! Now What?
Regulatory gurus Linda Chatwin and Walt
Murray explain what needs to be done to
maintain a continual state of regulatory
readiness. They walk through the steps that
should be taken when the FDA schedules
an inspection, and even what to do when
inspectors show up unannounced.
Passing Audits and Inspections with
MasterControl
MasterControl customers tell how
the solution simplifies audit processes,
impresses auditors, relieves audit concerns,
and gives them a competitive edge.
MasterControl for FDA Regulated
Companies
Learn how EQMS solutions can help
manufacturers avoid noncompliance and
get their products to market sooner. This
brief demo shows how compliance is
simplified when all quality processes are
integrated within a single platform.

FDA Readiness Toolkit

FDA Readiness Toolkit White Papers:

How to Successfully Complete an FDA Inspection

This white paper identifies key steps that device manufacturers, life science companies, and other organizations
operating in FDA-regulated environments should take before, during, and after an FDA inspection to ensure a
successful audit.

Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
This white paper proposes that an optimal EQMS is the foundation for long-term regulatory compliance and
offers six tips to help companies achieve such compliance and gain market success.

21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?

A thorough understanding of the importance of record integrity and inspection readiness is crucial for
compliance to 21 CFR Part 11. This white paper discusses these regulatory elements and demonstrates how
integrated software tools can facilitate compliance with the guideline.

Automating Document Control Processes to Comply with FDA and ISO Requirements
With a focus on document control processes within the quality system lifecycle, this white paper provides
insight into the capabilities needed to automate change control processes that will increase efficiency, ensure
compliance with FDA requirements, and improve profitability.

The Future of the FDA: Operating in an Electronic World

This white paper discusses FDA transformational activities that promise to usher in a new era of electronic
interactions between the agency and its constituents, and is based on primary research conducted by Axendia
Inc.

Managing Change Control to Comply with FDA and EU Regulations

Gain a better understanding of the elements of change control in regulatory environments and see how
compliant companies cope with various change control challenges like ineffective documentation, poor
communication, and disconnected quality processes.

FDA Readiness Toolkit Product Data Sheets:

MasterControl All Access Product Summary
Rather than cobbling together a collection of disconnected software components from different vendors, All
Access equips professionals with more than 30 specialized tools that work as a single solution and ensure that
users have the solutions they need, exactly when theyre needed most.

FDA Readiness Toolkit Consulting Services:

MasterControl Quality and Compliance Consulting (QCC) Regulatory Acceptance/Compliance Services
Learn how MasterControls team of seasoned professionals can provide expert guidance in a variety of areas
the FDA recognizes as critical, such as: regulatory acceptance and compliance; quality process training; supply
chain management; validation and qualification; certification and accreditation; new product development and
acceptance; and quality systems management.

FDA Readiness Toolkit

About MasterControl
MasterControl is a committed team of quality, regulatory and software experts who work to empower regulated
companies to get their products to market faster. MasterControls enterprise quality management software solutions
(EQMS) reduce overall costs, increase efficiency and accelerate compliance, creating a significant competitive advantage
for customers. Drawing upon unparalleled industry experience, MasterControl offers a suite of seamlessly integrated and
scalable software solutions for quality management, document control, training management, corrective and preventive
actions (CAPA), supplier management, audit management, clinical management and much more. MasterControls
complete EQMS is designed for easy implementation, validation and use, continually improving on the promise of
Compliance Accelerated. For more information, or to contact MasterControl, visit www.mastercontrol.com.

2016 MasterControl Inc. All rights reserved.

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FDA Readiness Toolkit