Comparison of QMSCAPA, ISO 13485 and US FDA 21 CFR

(Clause 4)

Quality management system requirements were developed to satisfy international medical device regulations.

(Subpart B)

Quality system refers to a medical device manufacturer’s responsibilities, procedures, processes, and resources for implementing quality management.

Conforms with 21 CFR parts 11, 210, 211, 820, 821, and quality standards like AS9100, AS9110, AS9120, ISO 9001, ISO 13485, ISO 14001, ISO 16949, ISO 17025, ISO 18001, ISO 20000, ISO 22000, ISO 27001, TL9000

(Clause 4)

Requires establishment of a quality management system for medical devices. A manufacturer must have quality procedures that are documented, controlled, and effectively implemented and maintained.

(Subparts C, D, E, G)

Require controls in design, document, purchase, and production process. This entails establishment of processes to ensure that a medical device conforms to specifications. Requirements stress maintenance of records of document changes, documentation of instructions of production processes and SOPs, and monitoring of process parameters.

The QMSCAPA suite of modules, automates, controls, and manages quality processes to improve efficiency and compliance. It can handle all types of documents, regardless of the software used to create them. It offers advanced routing, approval, escalation, and revision control.

(Clause 6)

A manufacturer must ensure that its personnel have the right experience, education, training, and skills. Acceptable levels of competence must be defined. Training needs must be established and assessed. A record of competence must be maintained.

(Subpart B, Sec. 820.25)

Each manufacturer must have sufficient personnel with the necessary background, training, and experience. It must have established procedures for identifying training needs and ensuring that employees are adequately trained to perform their jobs. Training should be documented.

QMSCAPA training controls role-based training requirements and employee competencies. It allows creation and deployment of training courses, requiring users to learn their duties and also demonstrate proficiency.

(Clause 8)

Remedial processes are required.

Quality should be monitored and measured by gathering customer feedback, setting up internal audits, establishing a non-conformance procedure, and analyzing quality information. Non-conformances must be corrected, recorded, and prevented.

(Subparts I, J)

Require establishment and maintenance of nonconformance and corrective and preventive action (CAPA) procedures. Nonconformances relating to product, processes, and quality system should be investigated. Actions needed to correct and prevent recurrence must be identified. Corrective action has to be validated to ensure effectiveness. All activities pertaining to nonconformance and CAPA must be documented.

QMSCAPA provides an integrated database for corrective and preventive action processes based on input of complaints or incidents, audits or investigations, out of specifications, deviations, non-conformances, and safety and defects issues. It accumulates data from multiple sources, manages trends, and automatically triggers subsystem processes to solve production issues before or after they arise. This module offers a pre-packaged, best practice set of electronic forms, and business analytics.

QMSCAPA 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 or data approval.

(Clause 7)

Requires development of procedures to identify and track products.

(Subpart F)

Requires procedures for identifying products.

QMSCAPA includes a feature for searching and identification of product items. A search can be made using the key fields associated with the database like type, description, or item name, or any user-defined field created by the customer.

(Clause 7)

Requires validation of monitoring and measuring software before use. Revalidation should be conducted when necessary.

(Subpart G, Sec. 820.70)

When computers or automated data processing systems are used as part of production or the quality system, the manufacturer should validate computer software for its intended use according to an established protocol. Validation activities and results should be documented.

When appropriate, QMSCAPA may be validated in accordance with FDA General Principles of Software Validation Guidance for Industry and FDA Staff.