FDA 21 CFR Part 820

Rule Number Regulation Ensur Document Control Software
Subpart B, Sect. 820.22 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. ENSUR 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.
Subpart B, Sect. 820.25 Each manufacturer must have sufficient personnel with the necessary background, training, and experience. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. ENSUR provides a comprehensive training module that enables the creation of training curriculum by job title. Training can be done on documents including a custom comprehension quiz as well as internal and external training events.  All training activity is automatically recorded and maintained in individual training records.
Subpart C, Sect. 820.30 (j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. ENSUR maintains DHFs through the use of our document managing system. Related documents to the DHFs can be easily linked through a combination of relationships to track and manage every version of the DHF.  Recall of each approved design can be retrieved through our search utility with complete audit trail functionality.
Subpart D, Sect. 820.40 Each manufacturer shall establish and maintain procedures to control all documents that are required by this part.  (a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. ENSUR workflow manages the creation, routing, review and approval of documents.  Designated individuals can be established by document type to make sure only appropriate individuals are on the approval activity routing. All user activity is automatically tracked in their activity log which corresponds to each document they approved. Audit logs can be quickly generated to produce the date/time group and electronic signatures of each approver.
Subpart G, Sect. 820.70 Each manufacturer shall establish and maintain procedures for changes to a specification, method, process, or procedure. Such changes shall be verified, or where appropriate, validated – before implementation and these activities shall be documented. ENSUR manages all standard operating procedures and specifications.  These critical business documents can be linked to the Change Control process where the identification of required changes are documented and verified.
Subpart I, Sect. 820.90 (a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. ENSUR document managing system controls nonconforming products through incident tracking. Multiple non-conformances can be grouped and further managed into a corrective and preventative action.
Subpart J, Sect. 820.100 (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. ENSUR manages CAPA and links the non-conformances that lead to the CAPA. A complete CAPA lifecycle is independently managed to include; review, analysis, approval, implementation, acceptance and verification
Subpart M. Sect. 184 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 and the requirements of this part. ENSUR manages DHRs so that the entire manufacturing process can be readily recalled. DHR specifications, testing reports, checklists, datasheets and system configurations are linked and the entire DHR can be stitched together into one consolidated report.
Subpart M, Sect. 820.198 Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. 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.