|Management System||The laboratory shall establish, implement and maintain a QMS management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, procedures and instructions to the extent necessary to assure the quality of the test results. The system’s documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel.||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, version control, corrective and preventative action, training, incidents, reporting and much more. ENSUR is available in both a validated and non-validated solution and helps you meet and exceed your various regulatory compliance requirements, including FDA, ISO, GxP, OSHA and SQF.
|Quality Manual||The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and reviewed during management review. The quality policy statement shall be issued under the authority of top management. The quality manual shall include reference to the supporting procedures including technical procedures and describe the structure of the documentation utilized in the laboratory.||The ENSUR out of the box electronic Binder Content Type and linking capability is the perfect solution for establishing a Quality Manual. Every document created and stored in ENSUR can be linked to other documents in the system via various link types, the most common being Referential or Dependent.|
|Document Control||The lab shall have a documented procedure (paper based, electronic or a combination) to control all documents that form the quality management system.||ENSUR automates the management of documents, their workflows and version control, helping you streamline your business processes and improve quality practices across your organization.|
|Review & Approval||The laboratory shall assure that all documents (including Standards) issued to or used by personnel in the laboratory as part of the management system are reviewed and approved for use by authorized personnel prior to issue.||ENSUR automates the workflow process for the Document product type through multi-tiered Review and Approval routings and Periodic Reviews with electronic signatures. Content can be manually made obsolete or through automation.|
|Complaints||The laboratory shall document, evaluate and adequately follow up on all customer complaints.||The ENSUR Incident product type allows laboratories to create custom forms utilizing the Incident workflow where items can be tracked as they are reported, Opened and Closed.|
|Control of Nonconforming Testing and/or Calibration Work||The laboratory shall have a procedure that shall be implemented when any aspect of its testing or the results of this work, do not conform to its own procedures or the agreed requirements of the customer.||ENSUR CAPA & Incident: ENSUR document control solution 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. Now you have 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) and Incident 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 and from draft through open and closed for Incidents.|
|Corrective Action||The laboratory shall establish a procedure and shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical.|
|Preventive Action||Needed improvements and potential sources of nonconformities, either technical or concerning the management system, shall be identified. When improvement opportunities are identified or if preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement.|
|The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews. Additional audits where the identification of nonconformities or departures casts doubts on the laboratory’s compliance with its own policies and procedures, or on its compliance with this international standard, the laboratory shall ensure that the appropriate areas of activity are audited as soon as possible.||ENSUR provides the ability to manage, schedule, and record all audit activities. Both internal and external audits can be recorded and tracked through its custom Form, CAPA, linking and action item features. ENSUR allows easily collaboration between different company departments in order to resolve and deviations or findings that may occur from an audit.|
|Training||The ENSUR Training feature allows you to easily 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.|
- 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.
- DocXellent Managed CloudThe DocXellent Managed Cloud (DMC) is the collection of people, competencies, and process controls provided by DocXellent that enables you to achieve well-architected, reliable, secure, durable, and compliant Cloud frameworks that promote business operations and growth.
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- 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.
- Specification ManagementSpecification Management is easy with our document management software, ENSUR. We can even migrate legacy content seamlessly for easy access.
- Packaging Specification ManagementSee how you can easily manage packaging documents, specifications and suppliers with our comprehensive document control software, ENSUR.
- Document 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.
- Change ControlSee how our document control management software, ENSUR, can automate your change control processes.
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- Quality Management SoftwareGuaranteeing that your products and services meet the standards of your clients is easy with our document management and quality control software, ENSUR.
- CAPA SolutionsEasily collect, correlate, investigate and make informed improvements to your processes with our CAPA management software, ENSUR.
- Intellectual Property ManagementOur document management system, ENSUR, helps you manage your critical business documents with a configurable level of security and control.
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- Life SciencesDocXellent's experience with Life Science companies will help comply with GMP and ISO Quality Standards. Save time and ensure compliance with document control management.
- Medical DevicesOur document management software can help with your medical device compliance. Contact us today for more document control information on the medical device industry.
- PharmaceuticalsOur document control software helps you easily satisfy auditor requests with a document master list for FDA & EPA compliance. Quality Document Control.
- LaboratoriesLaboratory companies must control their business content in accordance with the Clinical Laboratory Improvement Amendments (CLIA). See how our document control software can help.
- ManufacturingNeed help with document control management? Let DocXellent help you easily adhere to document management industry standards & OSHA manufacturing standards.
- PackagingDocXellent can help you step up your packaging game with our packaging specification management software. Learn more about how we can optimize your efficiency.
- HealthcareDocument Version Control is especially important in the ever changing healthcare industry. Get healthcare document control with DocXellent document software.
- CannabisThe alternative medicine and recreational cannabis industries are growing exponentially, and so are the requirements for complying with several regulations from governing bodies. Learn how we can help.
- 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 & BeautyFDA establishes the requirements for the cosmetic industry. Let DocXellent's document management system help you comply with regulations with 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.
- ChemicalChemical companies face many document control challenges that can be remedied with a document management system. Chemical industry EPA, OSHA, & FDA compliance.
- ServicesHaving a great documentation control approach is crucial in the service industry. Trust DocXellent with document management systems and control software needs.
- UtilitiesTrying to optimize document workflow and control for your company? Let DocXellent help you implement a tailor-made solution for your business.
- Government AgenciesThe ENSUR Policy Management Software eliminates inefficient filing processes and cumbersome paperwork by providing a secure platform for storing.
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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.
- Business ContinuityNeed to access your industry standards and regulations to see if you comply? Visit our DocXellent resources for information on document control requirements.
- 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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