|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
|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.|
|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.|
|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.
|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
|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.
|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.
|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.
- ENSUR Case Studies
- 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 Management SystemSee how you can easily manage packaging documents, specifications and suppliers with our comprehensive 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.
- Change ControlSee how our document control management software, ENSUR, can automate your change control processes.
- Training ManagementWe can help exceed your quality document management goals and report on employee training in seconds with our document management 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.
- 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.
- Document MigrationDocXellent has helped many clients, from Fortune 500 companies to smaller firms, migrate data into our ENSUR document control system.
- Document Control 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.
- Medical DevicesOur document management software can help with your medical device compliance . Contact us today for more document control information on the medical industry.
- PharmaceuticalsOur software for quality control lets 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).
- ManufacturingNeed help with document control management? Let DocXellent help you easily adhere to document management industry standards & OSHA manufacturing standards.
- PackagingDocXellent can help you mangage your document packaging specifications and much more with our business document software. Contact us for document control!
- 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.
- 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.
- Life Sciences
- Services and Support
- 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.
- ENSUR Support
- Our Company
- About UsDocXellent has been providing a trusted, web based document management system with quality control management solutions to companies from start-up businesses to the Fortune 500 since 1983.
- Meet the TeamMeet some of the team that makes DocXellent tick. Get to know the people who will be partnering with you in your success!
- Customers and PartnersThese are the brands and organizations that have experienced the power of our document control system, ENSUR
- BlogStay up to date on product and industry updates and get an inside look at our company.
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- Contact UsContact Us to receive more information about our product and services including document management software.
- Contact SalesWe are happy to answer any questions you have about our ENSUR software and we will gladly go at your pace.
- Contact SupportWe are here to help. Connect with one of our experienced support team members who can get you an answer to any question you may have.
- Request a DemoGet in touch to request a demo of our ENSUR document control management software.
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