FDA 21 CFR 820 & ISO 13485 Compliance

The DocXellent team works hard to make your regulatory process as simple as possible. Two of the regulations we know many of our customers must abide by are FDA 21 CFR 820 and ISO 13485. While 21 CFR Part 820 is a mandatory Food and Drug Administration (FDA) regulation for medical device companies looking to distribute products in the U.S., ISO 13485 is a voluntary standard that provides a framework for these companies to meet common regulatory requirements worldwide. The two standards work in tandem, with ISO 13485 serving as a strong foundation to meet FDA Part 820 requirements.

The table below demonstrates how our ENSUR Document Management Software meets the requirements of both FDA 21 CFR 820 and ISO 13485 to help you avoid non-compliance.

21 CFR 820 – Quality System Regulation ISO 13485 – Quality Management System Regulation ENSUR
Subpart(s)Outline/summaryClause(s)Outline/summaryCompliance Summary
B: § 820.20
§ 820.22
§ 820.25
Quality System Requirements:
Subpart B consists of Management Responsibilities, Quality Audit and Personnel of medical device manufactures for implementing quality management.
Organizational & Resource Requirements:
A Quality Management System (QMS) must be established that meets all applicable requirements and complies with the new ISO 13485 standard. A medical device manufacturer must also provide the resources necessary for a QMS and make sure that these resources are competent. Training records must be established and maintained.
The ENSUR QMS software application is developed to assist companies from all different industries to comply with various 21 CFR and ISO requirements. ENSUR can also help you meet training requirements through established training rosters including Users, Groups and Job Titles. ENSUR also features integrated Training Management capabilities, including internal & external training events and configurable training reports all while automating the tracking of your employees’ electronic training records. ENSUR training management monitors your training program with full and complete compliance and effectiveness. ENSUR employee training management software delivers the right knowledge and credentials throughout your organization using a fully documented and regulatory compliant solution. ENSUR also provides the ability to manage, schedule, and record all audit activities. Our audit report enables the organization of audit findings, suggestions and recommendations into a consolidated report that is generated with the actions performed and group or person responsible for the modification.
C: § 820.30
D: § 820.40
E: § 820.50
G: § 820.70
§ 820.72
§ 820.75
Design Controls, Document Controls, Purchasing Controls and Production & Process Controls:
The requirements of these subpart sections stipulate that each manufacturer shall establish and maintain the appropriate controlled documentation around the design of the device, purchased or otherwise received product and services must conform to specified requirements, and the monitoring of production processes to ensure that a device conforms to its specifications.
4.2Documentation Requirements:
The regulated company must establish a QMS and clarify your documentation requirements, establish a file for each family of medical devices, prepare a quality manual, maintain quality records, and to control all of these documents and records
ENSUR is a document control and quality management software application that automates the management of documents and their workflows, helping you streamline your business processes and improve quality practices across your organization.

The software provides a secure repository for storing and organizing your critical business documents with tools for collaboration, review & approvals, version control, corrective and preventative action, training, incidents, reporting and much more.
F: § 820.60
§ 820.65
G: § 820.75
Identification, Traceability & Process Validation:
Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix-ups.
7Product Realization & Validation:
This requires that a Quality Management System have procedures to identify and track products from the conceptual stage all the way through to its realization as a device.
The Fast Find feature in ENSUR offers powerful search capabilities to quickly and easily find any document or specification in the system by Code or Title. These search results can be quickly sorted by Code, Title, Content Type, Status or Created date. The ENSUR Advanced Search functionality offers more detailed searching capabilities. Searches can be performed by Content Type, electronic Forms and Layouts, document attributes and keywords. Electronic forms can be also be searched for component content, allowing users to craft very granular search results.
G: § 820.75 Process Validation:
When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.
7.5.6Process Validation:
Establish procedures to validate production and service delivery processes and software applications that could affect your products and services. Validate processes and software applications that could generate output deficiencies and could affect your products and services.
DocXellent offers multiple different validation services for the ENSUR application. Our software validation services provide industry standard services and products to meet all of your compliance and validation needs.

The link below provides a full explanation DocXellent Validation Services.

DocXellent Validation Services
I: § 820.90
J: § 820.100
Nonconforming Product & CAPA:
Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements and for implementing corrective and preventive action. These procedures shall define the responsibility for root cause analysis, review and the authority for the disposition of nonconforming product.
8Resource Requirements:
Clause 8
stipulates the requirements for measurement analysis and improvements of these processes. All organizations are required to create a plan and then apply to the monitoring, measurement, analysis and improvement processes needed in order to meet the conformity needs of the product, to ensure the conformity of the QMS, and maintain the effectiveness of the QMS.
ENSUR offers powerful out of the box tools for compliance in these areas. CAPA product type and workflow is a core functionality within ENSUR which grants you commanding flexibility when you find nonconformance, accidents, incidents, supplier issues, and customer complaints with your products or production processes. The ability to collect, correlate, investigate, and make informed improvements can be electronically executed within ENSUR. ENSUR offers streamlined quality and control throughout your manufacturing process. The ENSUR document control solution provides you a configurable, comprehensive anytime, anywhere Corrective Action Preventative Action (CAPA) tracking. The web forms help guide business and quality people to fully identify, record, define, investigate and correct any nonconformance found. The configurable workflow allows companies to monitor the solution from draft through effective implementation and verification of your corrective action/preventative action.

The ENSUR Forms functionality allows users with the correct system privileges to create customized forms for consistent data entry. Forms can then be routed through tiered review and approval workflows where electronic signatures can be applied.

ENSUR also offers extensive out of the box Reporting functionality for Administrators and general users to report and export critical data from within ENSUR. Highly customizable reports can also easily be created to give customers the ability to create any sort of report necessary for their organization.
M: § 820.184 Device History Record:
Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR.
-Device History Record’s are not required by ISOENSUR offers an out of the box Device History Record (DHR) electronic form or the ability to create a custom DHR form, which preserves a static set of links to specific versions of documents and will display those documents regardless of status change over time
M: § 820.198 Complaint Files:
Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
8.2.2Complaint Handling:
Develop and document complaint handling procedures for timely handling in accordance with applicable regulatory requirements.
ENSUR handles customer complaints in a similar manner to incidents that can lead to a CAPA. An independent workflow manages these complaints and links related specifications and procedures to the complaints.