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Compliance with 21 CFR

820 and ISO 13485
using MasterControl
What You Need to Know

What is 21 CFR 820 and 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
what is ISO 13485:2003
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.

Who is covered by 21 CFR 21 CFR 820 is applicable to manufacturers of finished medical
devices sold in the United States, including foreign manufacturers who
820 and who is covered by
import devices. Some manufacturers might be subject only to certain
ISO 13485? 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.

What’s the relationship Although the two are similar, they have significant differences. For
example, complaint handling and reporting requirements are integral
between 21 CFR 820 and to the FDA’s quality systems regulation (QSR), but the FDA thinks they
ISO 13485? 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.

Compliance with 21 CFR 820 and ISO 13485 using MasterControl 1


Who enforces 21 CFR 820 The Food and Drug Administration enforces 21 CFR 820.
and ISO 13485? 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.

What’s the connection Developed more than a decade ago, the MasterControl quality
management software solution was the first software specifically
between 21 CFR designed to help companies comply with FDA regulations and adhere to
820, ISO 13485, and ISO standards. Hundreds of companies worldwide rely on MasterControl
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.

What are some of The following are highlights of 21 CFR 820 and ISO 13485 and the relevant
MasterControl modules and features that are crucial in compliance.
MasterControl’s features
and how can they
help medical device
manufacturers comply
with 21 CFR 820 and
ISO 13485?

Compliance with 21 CFR 820 and ISO 13485 using MasterControl 2


21 CFR 820 ISO 13485 MasterControl™

(Subpart B) (Clause 4) MasterControl Quality Management

software solution was developed
Quality system refers to a medical Quality management system specifically to help companies comply
device manufacturer’s responsibilities, requirements were developed to satisfy with 21 CFR parts 11, 210, 211,
procedures, processes, and resources for international medical device regulations.
820, 821, and quality standards like
implementing quality management.

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

block within the MASTERControl Quality
Require controls in design, document, Requires establishment of a quality Suite, automates, controls, and manages
purchase, and production process. This management system for medical quality processes to improve efficiency
entails establishment of processes to devices. A manufacturer must and compliance. It can handle all
ensure that a medical device conforms have quality procedures that are types of documents, regardless of the
to specifications. Requirements stress documented, controlled, and effectively software used to create them. It offers
maintenance of records of document implemented and maintained. advanced routing, approval, escalation,
changes, documentation of instructions and revision control.
of production processes and SOPs, and
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. It education, training, and skills. courses, requiring users to learn
must have established procedures for Acceptable levels of competence must their duties and also demonstrate
identifying training needs and ensuring be defined. Training needs must be proficiency. It can be integrated
that employees are adequately trained established and assessed. A record of with MasterControl Documents to
to perform their jobs. Training should competence must 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.

Compliance with 21 CFR 820 and ISO 13485 using MasterControl 3


(Subparts I, J) (Clause 8) MasterControl CAPA automates

corrective/preventive action processes
Require establishment and maintenance Remedial processes are required. based on input of complaints/
of nonconformance and corrective and Quality should be monitored and incidents, audits/investigations, out of
preventive action (CAPA) procedures. measured by gathering customer specifications, deviations,
Nonconformances relating to product, feedback, setting up internal audits, nonconformances, and safety and
processes, and quality system should establishing a nonconformance defects issues. It collects data from
be investigated. Actions needed to procedure, and analyzing quality multiple sources, manages trends,
correct and prevent recurrence must be information. Nonconformances must and automatically triggers subsystem
identified. Corrective action has to be be corrected, recorded, and prevented. processes to solve production issues
validated to ensure effectiveness. All before or after they arise. This module
activities pertaining to nonconformance offers a pre-packaged, best practice set
and CAPA must be documented. of electronic forms, workflow routes,
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 easy. A search can be made using
identifying products. to identify and track products. the 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. A
Validation activities and results should MASTERControl Professional
be documented. Services consultant can also come
onsite to complete IQ/OQ validation
protocols and resolve any testing
deviations promptly.

Compliance with 21 CFR 820 and ISO 13485 using MasterControl 4


About MasterControl
MasterControl Inc. creates software solutions that enable life science and other
regulated companies to deliver life-improving products to more people sooner.
MasterControl’s integrated solutions accelerate ROI and increase efficiencies by
automating and securely managing critical business processes throughout the
entire product lifecycle. More than 1,000 companies worldwide, ranging in size
from five employees to tens of thousands, rely on MasterControl cloud solutions
to automate processes for new product development, clinical, regulatory, quality
management, supplier management, manufacturing and postmarket surveillance.
MasterControl solutions are well-known for being scalable, easy to implement, easy
to validate and easy to use. For more information, visit

Contact information and addresses

for other regional MasterControl
offices and MasterControl
partner offices are listed on
the MasterControl website at

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