The 21 CFR 820, also referred as Quality System Regulations (QSR), took effect on June 1, 1997, to provide a framework of a basic minimum requirement for manufacturers to establish an Enterprise Quality Management System (QMS).
Current Good Manufacturing Practice (cGMP) governs the practices used in designing, manufacturing, labeling and packaging, and servicing of finished devices that are intended for human use. Additionally, the cGMP also governs the facilities requirement for manufacturing and storing environment.
Qualityze Solution Information Matrix for 21 CFR 820
Qualityze eQMS is designed to help an organization to comply with 21 CFR 820. The following matrix will provide essential information for you to understand how Qualityze Solution can help:
|Requirements Section||Description||Qualityze Modules|
|820.20 Management Responsibility||Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality.
Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented.
Quality system procedures. Each manufacturer shall establish quality system procedures and instructions.
|820.22 Quality Audit||Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.||
|820.25 Personnel||Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.||
|820.40 Document controls||Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. Each manufacturer shall maintain records of changes to documents.||
|820.90 Non-Conforming Product||Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.||
|820.100 Corrective and Preventive Action||Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. All activities required under this section, and their results, shall be documented.||
|820.180 General requirements||All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer||
|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.||
Quality and Compliance Management Software
ISO 9001 Quality Management Software
ISO13485 Quality Management System
FDA 21 CFR Part 11 Software
AS 9100 Quality Management Software
TS 16949 Automotive QMS Software