|Requirement (informal interpretation)||ENSUR Document Control Software|
|The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs.||Quality documents may be drafted, approved and controlled within ENSUR. They may additionally be secured with print controls and watermarking.|
|The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable objectives.||ENSUR's Document Training enforces the reading and comprehension of documents in conjunction with an ENSURQuiz.|
|The business makes decisions about the quality system based on recorded data.||ENSUR's electronic Review cycle offers virtual collaboration.|
|The quality system is regularly audited and evaluated for conformance and effectiveness.||ENSUR's managed and scheduled periodic review cycles allow for the evaluation of documentation.|
|Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.||ENSUR's Binder and BOM templates offer the ability to link documents together in order to produce a ‘where used’ look up.|
|The business determines customer requirements.||Requirements may be drafted, approved and controlled within ENSUR. They may additionally be secured with print controls and watermarking.|
|The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.||ENSUR's configurable Distribution allows notifications and content to be emailed to users of ENSUR as well as external contacts. These emails are configured based on lifecycle events such as ‘upon Current and/or Historic’.|
|When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs.||ENSUR's comprehensive and configurable workflow allows for the incorporation of Action Items, Linking and Routing to allow for a full cycle of task initiations and completions.|
|The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits.||Internal Audit forms may be generated within ENSUR and electronically submitted for completion. This form data is then able to be extracted for reporting purposes. Additionally, Action Items and Periodic Reviews can tie into audit tracking.|
|The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness.||Incident tracking forms may be generated within ENSUR and electronically submitted for completion or users may work from the built in Incident template. ENSUR offers multiple lifecycle options that may be utilized in order to incorporate multiple departmental approvals and the resolution and closing of an Incident. Additionally, Action Items can tie into reporting.|
|The business has documented procedures for dealing with actual and potential non-conformances (problems involving suppliers, customers, or internal problems).||NCR forms may be generated within ENSUR and electronically submitted for completion or users may work from the built in CAPA template which includes a Non-Conformance section. ENSUR offers a multi-tiered CAPA lifecycle that may be utilized in order to incorporate multiple departmental approvals. Additionally, Action Items can tie into NCR reporting.|
| The business:||CAPA forms may be generated within ENSUR and electronically submitted for completion or users may work from the built in CAPA template. ENSUR offers a multi-tiered CAPA lifecycle that may be utilized in order to incorporate continuous improvement processes including Root Cause identification, Analysis, Implementation, Acceptance and Verification. Additionally, Action Items can tie into reporting.|
- 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.
- 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 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.
- Training ManagementWe can help exceed your quality document management goals and report on employee training in seconds with our document management software, ENSUR.
- 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.
- 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 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.
- Life Sciences
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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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