|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.|
- ENSURENSUR is an easy-to-use, configurable, web-based Document Management and Quality Control Software System that will dramatically help you to improve and manage the efficiency of paper based or uncontrolled electronic file based processes.
- ENSUR CloudWhether you’re an existing customer, a company looking to make a change in your provider or implementing your first document control, packaging specification, training management or quality system, DocXellent can provide the option of on-premises or a robust, secure and proven cloud based installation.
- CAPA SolutionsEasily collect, correlate, investigate and make informed improvements to your processes with our CAPA management software, ENSUR.
- Change ControlSee how our document control management software, ENSUR, can automate your change control processes.
- Document Control SoftwareControl your organization’s content across the globe or down the hallway with our flexible, secure, user-friendly online document control software, ENSUR.
- Version ControlYour document control management protocol encompasses a wide variety of processes integral to the continued flow of your business. Version control, and how it’s handled, is often a pain point for companies, especially those managing content with paper or a file share.
- Intellectual Property ManagementOur document management system, ENSUR, helps you manage your critical business documents with a configurable level of security and control.
- Deviations & ComplaintsBusinesses that have their IP content under control thrive. Whether its process documentation, sales and marketing literature or trade secrets and proprietary content, knowing that the right versions of your content have been reviewed and approved is tantamount to your success.
- Packaging Management SystemSee how you can easily manage packaging documents, specifications and suppliers with our comprehensive document control software, ENSUR.
- Quality Control ManagementGuaranteeing that your products and services meet the standards of your clients is easy with our document management and quality control software, ENSUR.
- Specification Document ManagementSpecification Management is easy with our document management software, ENSUR. We can even migrate legacy content seamlessly for easy access.
- Training ManagementWe can help exceed your quality document management goals and report on employee training in seconds with our document management software, ENSUR.
- CAPA Solutions
- CannabisThe alternative medicine and recreational cannabis industries are growing exponentially, and so are the requirements for complying with several regulations from governing bodies.
- ChemicalChemical companies face many document control challenges that can be remedied with a document management system. Chemical industry EPA, OSHA, & FDA compliance.
- Food and BeverageOur document management software helps companies in the food & beverage industry comply with FDA audit & SQF audit control guidelines. Contact DocXellent today!
- Health and BeautyFDA establishes the requirements for the cosmetic industry. Let DocXellent's document management system help you comply with regulations with document control.
- HealthcareDocument Version Control is especially important in the ever changing healthcare industry. Get healthcare document control with DocXellent document software.
- Life SciencesDocXellent's experience with Life Science companies will help comply with GMP and ISO Quality Standards. Save time with document control management versioning.
- ManufacturingNeed help with document control management? Let DocXellent help you easily adhere to document management industry standards, & OSHA manufacturing standards.
- Medical DevicesOur document management software can help with your medical device compliance . Contact us today for more document control information on the medical industry.
- PackagingDocXellent can help you mangage your document packaging specifications and much more with our business document software. Contact us for document control!
- Nutritional and Dietary SupplementsOur software can help keep you compliant with FDA/CFR guidelines. Let DocXellent help you and your company manage business content with document control.
- PharmaceuticalsOur software for quality control lets you easily satisfy auditor requests with a document master list for FDA & EPA compliance. Quality Document Control.
- ServicesHaving a great documentation control approach is crucial in the service industry. Trust DocXellent with document management systems and control software needs.
- UtilitiesTrying to optomize document workflow and control for your company? Let DocXellent help you implement a tailor-made solution for your business.
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- ENSUR SupportThe DocXellent support team is available twenty-four hours a day; seven days a week; three hundred sixty-five days a year. Our U.S. based team works around the clock to keep your business running.
- Resources and InformationNeed to access your industry standards and regulations? Visit our DocXellent resources page for more useful information on document control systems and regulations.
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