Compliance With 21 CFR 820 and Iso 13485 Using Mastercontrol

Q&A:
Compliance with 21 CFR

820 and ISO 13485
using MasterControl
What You Need to Know

Q: What is 21 CFR 820 and what is ISO 13485:2003
A: Title 21 of the Code of Federal Regulations (CFR) covers the broad area of food and drugs, but Part 820 pertains to
quality systems for medical devices. It outlines Current Good Manufacturing Practice (CGMP) regulations that govern
the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage,
installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that
medical devices are safe, effective, and in compliance with the Federal Food, Drug, and Cosmetic Act.
ISO 13485:2003 is an international standard that specifies requirements for regulatory purposes for medical device
manufacturers. It provides a framework for companies to meet their customer and regulatory requirements. The main
goal is to provide a harmonized model for quality management system requirements in the international market since
different countries might have different standards. ISO (derived from the Greek word isos, meaning equal) refers to the
International Organization for Standardization, a non-governmental organization based in Geneva.
Q: Who is covered by 21 CFR 820 and who is covered by ISO 13485?
A: 21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States, including foreign
manufacturers who import devices. Some manufacturers might be subject only to certain requirements, depending on
the operations they are engaged in.
Medical device manufacturers that sell their products in the global market find it advantageous to get ISO 13485
certification because ISO standards are recognized worldwide. Certain countries require such certification. Many
customers also prefer medical devices that are ISO certified.
Q: What’s the relationship between 21 CFR 820 and ISO 13485?
A: Although the two are similar, they have significant differences. For example, complaint handling and reporting
requirements are integral to the FDA’s quality systems regulation (QSR), but the FDA thinks they are not adequately
addressed in ISO 13485. In this case, conformity to the ISO standard would not suffice to demonstrate conformity
with the QSR and the FDA’s Center for Devices and Radiological Health will not recognize the standard for this
particular purpose.
Q: Who enforces 21 CFR 820 and ISO 13485?
A: The Food and Drug Administration enforces 21 CFR 820.
Third parties usually conduct assessment of a manufacturer’s system and processes to make sure they are in accordance
with the requirements of ISO 13485.
Q: What’s the connection between 21 CFR 820, ISO 13485, and MasterControl?
A: Developed more than a decade ago, the MasterControl quality management software solution was the first software
specifically designed to help companies comply with FDA regulations and adhere to ISO standards. Hundreds of
companies worldwide rely on MasterControl to help them automate, document, control, track, interconnect, and
manage their quality processes.
MasterControl v4.0 offers a holistic software solution to medical device manufacturers’ needs pertaining to compliance
with 21 CFR 820 and ISO 13485. It’s a configurable, off-the-shelf software that’s easy to use, install, implement, and
validate. The different MasterControl modules — MasterControl Documents, MasterControl Forms, MasterControl
CAPA, MasterControl Training, MasterControl Submissions, MasterControl Collaboration, and MasterControl PDF
Publishing — can be used as stand-alone applications or as an integrated system under a single Internet-based portal.
MasterControl offers comprehensive services that include hands-on software training, installation assistance,
validation services, and continuing customer and technical support. The MasterControl solution helps medical device
manufacturers’ quality processes stay compliant, connected, and complete.
Q & A : Compliance with 21 CFR 820 and ISO 13485 using MasterControl
Q: What are some of MasterControl’s features and how can they help medical device manufacturers comply
with 21 CFR 820 and ISO 13485?
A: The following are highlights of 21 CFR 820 and ISO 13485 and the relevant MasterControl modules and features that
are crucial in compliance.
21 CFR 820 ISO 13485 MasterControl™
(Subpart B) (Clause 4) MasterControl Quality

Management software solution was
Quality system refers to a medical Quality management system developed specifically to help companies
device manufacturer’s responsibilities, requirements were developed to satisfy comply with 21 CFR parts 11, 210, 211,
procedures, processes, and resources international medical device regulations. 820, 821, and quality standards like
for implementing quality management. ISO, QS/TS.
(Subparts C, D, E, G) (Clause 4) MasterControl Documents,

the building block within the
Require controls in design, document, Requires establishment of a quality MASTERControl Quality Suite,
purchase, and production process. This management system for medical automates, controls, and manages
entails establishment of processes to devices. A manufacturer must have quality processes to improve efficiency
ensure that a medical device conforms quality procedures that are documented, and compliance. It can handle all types
to specifications. Requirements stress controlled, and effectively implemented of documents, regardless of the software
maintenance of records of document and maintained. used to create them. It offers advanced
changes, documentation of instructions routing, approval, escalation, and
of production processes and SOPs, and revision control.
monitoring of process parameters.
(Subpart B, Sec. 820.25) (Clause 6) MasterControl Training controls

role-based training requirements and
Each manufacturer must have A manufacturer must ensure that its employee competencies. It allows
sufficient personnel with the necessary personnel have the right experience, creation and deployment of training
background, training, and experience. education, training, and skills. Acceptable courses, requiring users to learn
It must have established procedures for levels of competence must be defined. their duties and also demonstrate
identifying training needs and ensuring Training needs must be established and proficiency. It can be integrated with
that employees are adequately trained assessed. A record of competence must MasterControl Documents to
to perform their jobs. Training should be maintained. automatically task trainees when
be documented. required SOPs or other documents
change and a new training becomes
necessary. This software automatically
performs gap analysis for all training
tasks, all the time.
2
(Subparts I, J) (Clause 8) MasterControl CAPA automates
corrective/preventive action processes
Require establishment and Remedial processes are required. Quality based on input of complaints/
maintenance of nonconformance should be monitored and measured incidents, audits/investigations, out of
and corrective and preventive action by gathering customer feedback, specifications, deviations,
(CAPA) procedures. Nonconformances setting up internal audits, establishing nonconformances, and safety and
relating to product, processes, and a nonconformance procedure, and defects issues. It collects data from
quality system should be investigated. analyzing quality information. multiple sources, manages trends,
Actions needed to correct and prevent Nonconformances must be corrected, and automatically triggers subsystem
recurrence must be identified. recorded, and prevented. processes to solve production issues
Corrective action has to be validated before or after they arise. This module
to ensure effectiveness. All activities offers a pre-packaged, best practice set
pertaining to nonconformance and of electronic forms, workflow routes,
CAPA must be documented. and business analytics.
MasterControl Forms, a closely

related module, offers the capability
to create electronic forms that look
identical to existing forms or create new
ones altogether. This module integrates
workflow processes, data entry, and
form/data approval. It also offers
business analytics. As users complete
input along the workflow, the form is
automatically routed to the next user.
(Subpart F) (Clause 7) MasterControl’s InfoCard feature

makes searching and identification
Requires procedures for Requires development of procedures to easy. A search can be made using the
identifying products. identify and track products. metadata associated with the InfoCard
like document type, vault, or author,
or any unique field created by the
customer. MASTERControl’s Organizer
tool is similar to “Windows Explorer,”
allowing even users with minimal
computer skills to quickly find and
access documents. The same documents
can be housed in multiple Organizers
across the company.
(Subpart G, Sec. 820.70) (Clause 7) MasterControl validation services

are comprehensive. The Validation
When computers or automated data Requires validation of monitoring Toolkit offers detailed, prewritten
processing systems are used as part and measuring software before use. installation qualification (IQ) and
of production or the quality system, Revalidation should be conducted operational qualification (OQ)
the manufacturer should validate when necessary. validation test protocols and scripts,
computer software for its intended use so a company can complete necessary
according to an established protocol. validation requirements on its own.
Validation activities and results should A MASTERControl Professional
be documented. Services consultant can also come
onsite to complete IQ/OQ validation
protocols and resolve any testing
deviations promptly.
Q & A : Compliance with 21 CFR 820 and ISO 13485 using MasterControl
Related Videos
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Using MasterControl for ISO Certification
Using MasterControl for FDA Compliance
About MasterControl Inc.
MasterControl produces software solutions that enable regulated companies to get their products to market faster, while
reducing overall costs and increasing internal efficiency. MasterControl securely manages a company’s critical information
throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate, and easy to
use. MasterControl solutions include quality management, document management, product lifecycle management, audit
management, training management, document control, bill of materials, supplier management, submissions management, and
more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers
with a complete information management solution across the enterprise. For more information about MasterControl, visit
www.mastercontrol.com or call 1.800.825.9117 (U.S.); +44 (0) 1256 325 949 (Europe); or +81 (03) 5422 6665 (Japan).
© 2015 MasterControl Inc. All rights reserved.

QAXXXXUSENLT-04/13
4
Corporate Headquarters: European Headquarters:
MasterControl Inc. MasterControl Global Limited
Salt Lake City, UT Basingstoke
United States United Kingdom
Phone: 1 866 747 8767 Phone: +44 (0) 1256 325 949
Asian Headquarters: Contact information and addresses for

MasterControl KK other regional MasterControl offices and
Tokyo MasterControl partner offices are listed
Japan on the MasterControl website at
Phone: +81 (3) 5422 6665 www.mastercontrol.com.

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Q&A:

Compliance with 21 CFR

What You Need to Know

Q: Who is covered by 21 CFR 820 and who is covered by ISO 13485?

Q: What’s the relationship between 21 CFR 820 and ISO 13485?

Q: Who enforces 21 CFR 820 and ISO 13485?

A: The Food and Drug Administration enforces 21 CFR 820.

21 CFR 820 ISO 13485 MasterControl™

(Subpart B) (Clause 4) MasterControl Quality

(Subparts C, D, E, G) (Clause 4) MasterControl Documents,

(Subpart B, Sec. 820.25) (Clause 6) MasterControl Training controls

MasterControl Forms, a closely

(Subpart F) (Clause 7) MasterControl’s InfoCard feature

(Subpart G, Sec. 820.70) (Clause 7) MasterControl validation services

Using MasterControl for ISO Certification

Using MasterControl for FDA Compliance

About MasterControl Inc.

© 2015 MasterControl Inc. All rights reserved.

Asian Headquarters: Contact information and addresses for

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