GRC Solution Suite. EQMS Document Manager

Transcription

1 GRC Solution Suite EQMS Document Manager EQMS Document Manager delivers unshakeable control over your policies, procedures and other critical documentation for both SME's and large, multinational enterprises. EQMS reduces the compliance burden associated with Standards and Regulations. 9001, 14001, 27001, 31001, 45001

2 HIGHLIGHTS Document Attributes Add your own attributes to the standard set for each type of document in your system. Document Search Powerful text and attribute search combines with sophisticated filtering capability to deliver rapid results. Document History EQMS Document Manager records all document access and modification. Changes to records, documents, or data fields create auditable records. Alerts and Notifications EQMS Document Manager s event-based tasks, notifications, alerts and escalations to drive action. Access Control Multi-level, role-based access control supports multi-site organisations with multiple products and business divisions. Configurable Workflow Automated workflows route documents through creation, review, approval, and archive. Each document type is assigned an appropriate life cycle. A Cornerstone for Quality Management and Regulatory Compliance Effective document control is central to quality management and regulatory compliance. Manual and paper-based processes for managing policies and control documents are inefficient, costly, and unsustainable. The volume of policies, processes, SOPs and quality, regulatory & compliance records is escalating, with bottlenecks and delays often holding back the growing business. Managing the delivery, acknowledgement and review cycle presents a heavy administrative overhead that many organisations struggle to contain. Rapid retrieval of important information presents a constant challenge and the use of out-of-date, inaccurate content jeopardises standards and regulatory compliance. Structuring, controlling and distributing policies, procedures and process documents is essential to underpin governance, automate compliance and minimise risk. Electronic systems are critical to reduce error, speed up processing and reduce cost. A document management solution is the ideal way to store your information assets and allow stakeholders to make full use of your knowledge base. And, with job mobility a constant threat, the argument for capturing know-how is even more compelling. An Introduction to EQMS Document Manager EQMS Document Manager is a web-based solution that enables you to automate document management across your enterprise. It provides an easy-to-use, central information repository storing and organising documents for access from your desktop, tablet or mobile device. Predefined workflow helps to drive the access, creation, modification, review, and approval of documents in a controlled manner throughout the organisation. Users are presented with a view of documentation tailored to their specific needs, which is easy to navigate and search. They see read-only, approved content in the form of current, authorised versions of documents and files. Content is relevant to their personal position and access permissions. Content takes the form of simple or compound documents, word processor files, spreadsheets, graphics, video, audio, web pages and business applications. Managers quickly and easily create and manipulate the navigational structure and create rule sets that define how each document type is managed with an appropriate set of attributes for each. This streamlines all subsequent upload and modification. Powerful reporting and dashboard capability 2

3 track documents from origin to obsolescence, providing managers with visibility and insight. EQMS Document Manager eliminates the cost and effort associated with paper-based systems, delivering cost savings, increasing usability and ensuring compliance with business standards. HIGHLIGHTS Integration EQMS Document Manager integrates seamlessly with all EQMS modules and Mobile Phone/ Tablet technology to deliver a secure, comprehensive, closed-loop GRC solution with maximum accessibility. Management Information A customisable dashboard and report suite provide all your document lifecycle metrics. No programming required and report outputs are available in MS Word, MS Excel, and Adobe PDF. Benefits that Deliver Competitive Advantage EQMS Document Manager is a powerful, flexible and highly configurable solution trusted by global organisations across a range of regulated industry sectors. It provides an array of benefits: A secure, central repository provides efficient storage of documents, policies, processes and procedures Documents are rapidly located, up-dated or removed from circulation to underpin compliance Workflow and collaboration improves communication and teamwork across departments and functional areas Enterprise-wide visibility of document status delivers transparency and metrics support performance improvement Accelerated review and approval cycles drive better quality content Users see content in a consistent framework and have total confidence in the documents in circulation Faster access to authorised content and a comprehensive audit trail of change lowers the cost of compliance with standards and regulation 3

4 Features & Benefits Document Storage EQMS Document Manager provides a central repository for storing and organising all types of documents in their native file format word-processed documents, flowcharts, spreadsheets, CAD/CAM files, graphics, audio, video... EQMS accepts file formats from all browser-compatible applications used by the user. Access to the EQMS repository is encrypted to underpin security and ensure document integrity. Users may access the repository via the EQMS applicationor via EQMS apps for mobile phone and tablet. Documents are created or edited using your existing applications for subsequent load thus minimising the training need. Document Navigation EQMS presents users with a graphical representation of the information structure that allows simple navigation of company documentation. The structure is completely tailorable and is most effective when familiar to the user base. It reflects the organisation s business processes, its projects, its operational structure or mirrors the chapters of procedural manuals. In-built functionality allows you to quickly set up links to documents within the structure that reflects the real use of documents. Thus links to your own internal documents can be placed alongside links to pages drawn in from the Internet; for example, your suppliers online ordering pages positioned next to your purchasing policies and procedures EQMS presents documents to users, either in their native format, or in locked and templated PDF format and preserves the integrity of hyperlinks between documents, automatically preserving links between versions. Users navigate through live, current versions of documents that are read-only with change controls restricted to authorised users. The system automatically stores a record of your recently-viewed documents and allows you to register favourites to facilitate rapid access to regularly-used content. Document Format Documents are presented to users, either in their native format, or in locked and templated PDF format, depending on your needs. Any type of document format can be stored and viewed, including text, forms, flowcharts, spreadsheets, video and audio, and in formats such as Microsoft Word, Excel and PowerPoint, PDF, WAV and Gif. In short, it will store and represent a file of any type which the user organisation supports. Rich 4

5 content such as video is increasingly useful to describe processes and procedures. EQMS works with viewing applications to minimise licence costs of business software. Search EQMS provides powerful search across all those documents which the User is authorised to access. Full text search of the document library provides results which are graded by the number of search hits. EQMS employs a range of other search criteria based on the content of document fields such as Title, ID, Date of Issue and Status. Add to this your own userdefined fields to custom build document search criteria for your Users. EQMS stores your personal search parameters for reuse. Document Creation, Review & Approval EQMS allows you to configure different management processes for different types of document. Your processes can be as simple or as sophisticated as you require. Workflow processes are defined to manage acknowledgement, review, approval, issue, notification and escalation processes. You may add electronic signatures to as many steps in the process as required and integrate with third party applications to deliver physical signatures on your documents. You may configure the frequency and number of reminders, and define escalation routines to increase compliance with action requests. EQMS then automatically triggers review, approval and archive instructions via the system, via using a variety of user interfaces; PC, laptop, mobile-phone or tablet. 5

6 Tasks for reviewing, approving, issuing and acknowledging documents are assigned to individual Users or groups of Users along with due dates. notifications and reminders keep the process on track with escalations triggered when due dates are not met. Users may be asked to acknowledge new or changed content by electronic signature depending on the type of document. notifications and reminders keep the process on track with escalations triggered when due dates are not met. The system retains a full record of all review and approval activity storing responses, names, dates and compliance or otherwise with target deadlines. EQMS simplifies the process of creating new documents or making changes to existing ones. It Users may initiate requests for the documentto be taken through an electronic workflow of drafting and update. Cross-functional teams can work on a document at the same time, adding annotations without modifying the original and routing the document back to the author for change. On completion of the review and approval process, the document is issued with notifications sent to a distribution list. Document Upload Documents are uploaded quickly and easily into the system in their native format (Microsoft Word, Excel, PowerPoint, PDF, WAV, JPEG, Gif, Tiff and virtually any common file type), where they are held securely under a unique identity. Content from the internet is also held in the database with a unique identity: instead of holding a copy of the file, the document record holds its URL (Universal Resource Location). Documents are loaded individually, or, for files, by batch or programmed loading from any folder location on your company network. EQMS is also able to download, upload, check-out and checkin documents from/to its document store via MS Office applications Word, Excel, PowerPoint and Outlook add-ins. Managers can pre-determine both document types and storage locations for named uploads so as to automate commonly used processes. Checkin/Checkout The facility to check a document out, and to check it back in again, may be provided for any Document within the system. Its purpose is to stop other users unwittingly overwriting amendments which an individual is preparing offline. The identity of the person checking out is displayed, so that appropriate steps can be taken to have it checked back in, or whatever. A Document may not be superseded by a new Version when it is checked out, but copies may still be taken. 6

7 Document Families & Attributes EQMS allows you to define for each family of documents (or Document Type) which you manage, the behavioural attributes of its documents. Some of these may be declared either modifiable or enforced (ie unmodifiable). These are automatically attached to each document on upload, to speed up the document creation process. EQMS uses automatic or user-defined numbering schemes or user-supplied identities for documents, in addition to its unique identifiers. It also applies review and expiry dates where required. It also indicates who will have access to the document and who will be able to replace it with a new version. You can also define any number of your own user-defined fields to be applied to the document family. These fields will be labelled and require selection from a dropdown or Yes/No or supply of text, number, or date, as indicated. The data in these fields will aid subsequent document search and analysis. EQMS Document Manager allows you to modify information about each document: reference numbers, titles, synopses, version numbers, review dates, document ownership, document permissions, links to organisational areas and standards, along with the entries in any additional user-supplied fields, except for those attributes where the document type has declared enforcement. Version Control EQMS retains each superseded version of a document in the repository based on your retention policy. It retains all the attributes stored against each version to complete the history. It restricts access to the history of any given document to authorised users. Superseded document versions are locked to prevent destruction or tampering. Your rules apply to govern the review and approval of suggested changes by document type and access to archived versions of documents is restricted to appropriate users. Audit Trails The system automatically generates complete change histories, maintaining an archive of expired documents with the same feature-rich search capabilities for locating specific documents in the archive. In addition to user defined numbering, EQMS automatically generates a system ID for each document, recording access hits and date of last retrieval. The system provides accurate time-stamped audit trails with what, who, when, and why information for document access, changes, and 7

8 comments. Electronic signatures based on robust authentication and authorisation ensure compliance with regulations such as FDA 21 CFR Part 11. Security EQMS Document Manager ensures secure document access with centrally managed policy-driven controls. Rights to view, modify and distribute documents are granted based on system-defined roles and user-defined groups. Distribution lists can be defined for a document type and records of check-out and check-in are maintained. Security allows you to define system user accounts and groups and assign permissions to them as appropriate. Different permissions can be assigned to different groups to determine whether they can merely view documents or amend and record information. You control the viewing of documents down to the individual user level. Some documents may be visible to all users; some may be restricted to individuals or groups with appropriate permissions. This not only preserves information security and but also prevents information overload. History Authorised managers have access to a complete audit trail of changes made to all records in EQMS Document Manager. This provides you with a complete historical record of change that provides a record of due diligence and compliance. You, your auditors and assessors have an easy-to-read view of changes made over the entire history of a record or over a chosen period of time. In addition, you are able to view how a given record looked at a particular point in time. This satisfies all regulatory demands for data integrity. Management Control You quickly and easily define administrator rights for managing content. You define and control any devolvement of document management responsibility to individuals or groups by giving them access permissions. They will only be able to administer the documents for which you give them permission. They, in turn, may devolve responsibility for elements of their documents to other individuals or groups. Feedback The Feedback option loads the compose screen of your system and automatically routes a message to the owner of the document you are viewing. The user is able to quickly comment, make suggestions and identify problems. Managers can access a complete history of feedback for a document where feedback retention is required. This may be invaluable for review and maintenance. 8

9 Document Signatures EQMS integrates with third party applications to electronically generate physical signatures on documents. This supports online signature for contracts and where regulation demands a locked record incorporating a signature. Mobile Device Access Access your EQMS system via your mobile phone or tablet. Documents are then available from a secure environment whenever you need them. This is perfect for organisations with a mobile workforce who need access to procedural, process and form documentation from a customer site or remote location. Document Compare To assist with production of new versions of documents an optional add-on facilitates the comparison of two versions of a document and reporting on the differences between them. MS Office Integration Access EQMS documents and embed EQMS compliance controls using your favoured business applications (Outlook, Word, Excel, PowerPoint, SharePoint). This reduces the need to switch between applications and minimise training requirements. Automate the loading of content generated in other business applications (SAP, ERP, SalesForce, Sage etc.). This embeds compliance in the way your organisation operates, minimising error and reducing risk. To Do List EQMS automatically generates targeted To Do List messages or Actions plus prompts for review, approval, archive etc. of documents held in the system. Actions are triggered by dates and deadlines held in the database and compliance with requests is analysed and reported. 9

10 Seamless Integration EQMS Risk Manager is integrated with all other EQMS modules, allowing you to see any associated audits, documents or issues for a risk when you view them in Risk Manager. All messages triggered by Risk assessment and resolution are passed directly into your system so as to automatically involve the required stakeholders in review decisions. These can be accessed and responded to on a PC, laptop, mobile or tablet. To maximise the benefit of messaging, and support compliance, there are options to configure the frequency and number of reminders and to define escalation routines. Your decisionmaking is always completely informed by all of the information at your organisation s disposal. In addition, EQMS is complete with a set of web services to speed up the process of integration with a range of other commonly-used business applications and to minimise the effort and cost of any bespoke integration requirement. Dynamic Reporting & Metrics EQMS reporting provides complete visibility of document management processes and lifecycles and simplifies status tracking. Reports present complete traceability of records. Graphical dashboards include drill-down capabilities to provide statistics and underlying data by use of parameter settings for things such as document type, status, history, review and approval, cycle time versus target, document usage summaries, and average review time. Your personal parameter settings may be saved for subsequent use. Indeed, you can save more than one setting for each report. Tools & Help Users have access to context-sensitive help screens and a range of system tools. The precise tool-set varies depending on the permissions of the user but includes the ability to view one s own user details and broadcast messages to groups of colleagues. With one mouse-click, users can check on the status of the document they are viewing. Status information can include issue date, review date, approver(s), owner, synopsis and even your own classification schemes. Branding & Localisation Add logos, colours, style sheets to ensure EQMS emulates the look and feel of your web presence, extranet or intranet. Localise EQMS by tailoring EQMS phrases and labels to match your organisation s taxonomy. Add other EQMS language versions to support your users by eliminating language barriers. 10

11 Technical Flexibility We offer EQMS on a SaaS basis with your users accessing your system via a secure https website. Alternatively, we install EQMS on your network integrating with your intranet, extranet or company portal as required. You choose the deployment option that best suits your organisation s forward IT strategy. You access EQMS Document Manager via your laptop or PC using any commonly-used web browser. You can also access EQMS Document Manager via your tablet or mobile phone providing complete accessibility on the move. 11

12 Founded in March 1995, Qualsys Ltd is a leading provider of best-of-breed Governance, Risk and Compliance solutions that is privately owned, profitable and certified to ISO 9001/TICKIT and UKAS/ANSI RAB (certificate 1857/99). Our flagship EQMS solutions help customers eradicate the compliance burden of a vast array of regulations and international standards such as ISO 9001, ISO 14001, ISO 27001, ISO and ISO 45001/OHSAS EQMS standardises processes, underpins corporate governance and provides a robust framework for managing risk. Our solutions drive down cost and deliver tangible competitive advantage - online or on-premise deployment combines with expert support and training to provide rapid return on investment. EQMS is used in over 100 countries worldwide across a range of business sectors from blue-chip organisations as diverse as Astra Zeneca, BT, Carillion and Diageo to smaller organisations committed to continuous quality improvement. Qualsys Ltd is registered in England, number Trusted by users in over 100 countries:

13 Request Demonstration and download the EQMS Buying Toolkit Tel: +44 (0) Fax: +44 (0) Web: Qualsys Ltd Aizlewood s Mill, Nursery Street, Sheffield S3 8GG, UK Document Manager compliance.eqms.co.uk/blog