Enterprise Content Management for the Digital Age

Cloud-Based Digital Platform for Managing Enterprise Content

Based on our Digital Acceleration Platform (XDP), ECM XD enables collaboration with all stakeholders and derives insights and intelligence from digital documents and metadata. ECM XD provides a single, out-of-the-box, yet highly configurable solution to holistically manage all of your contents, documents, and images in a single digital environment.

ECM XD helps businesses simplify collaboration, create content, and transmit and assure compliance across all parts of the business processes. ECM XD's built-in regulatory controls enable holistic management of compliance.

Content Ecosystem Management

Content Services Management

Value Chain Connectivity

Manage your entire digital ecosystem by capturing structured and unstructured content, documents, and images.   

Document Assets

The embedded content management system provides document versioning, history, security, multiple documents filing views, auto-filling of documents, and search capabilities to ensure that documents can be controlled following the organization’s compliance objectives.

Rich Media Assets

With ECM XD’s rich media assets, such as pictures and video can be stored, managed, and retrieved easily.  Images can be embedded within the business process forms and uploaded with the records.

Metatags and Indexing 

Structured and unstructured content with metatags can be stored and the information is indexed for easy search and retrieval.

ECM XD seamlessly uploads, processes, and distributes content assets under prescribed rules.

ECM XD allows automated uploading of documents into the repository via Secure File Transfer Protocols, Scanning, and e-mail drop.  Each document can be index with meta-tags and filed in the repository under the correct file structure and with the appropriate tags and security.

Scanning and Image Management

Scanned documents and images are digitized, annotated, and embedded in the rule-based workflows, tagged, and filed in defined file structures.

Publishing and Expiring of Documents

Works with the life cycle compliance management to ensuring content is published and withdrawn at the appropriate time.

ECM XD’s integration framework connects stakeholders in a secure environment and streamlines business processes.

Collaboration

External and internal stakeholders can connect and communicate with full transparency of critical information.  The granular security and dashboard configurability promote a role-based user experience while ensuring privacy and data protection.                     

Offline Workplace

The Digital Workplace also provides the Offline Workplace so users can work in a variety of offline scenarios and synch the data with the system at a later time. 

Unified Operational Integration

With the integration framework and associated tools, the Digital Workplace Solution is seamlessly extensible to enterprise systems and applications.

Key Features:

ECM XD Benefits

Link critical business data to key controlled documents

  • Seamless integration allows users to access key documents such as SOPs, Material Safety Data Sheets (SDS or formerly MSDS) documents, procedures, process reports, contracts, insurance certificates, and all other documents important to your enterprise.

Improve Access, Accuracy, and Velocity of Information Flow

  • Embedded notifications, workload management, and dashboard results provide visibility to key activities, indicators, and risks for resolution. Eliminates all manual steps in the life cycle of a document, including change management.

Lower Total Cost of
Ownership

  • Documents can be searched in one common area and can also be found in related records. Favorites and dashboard lists assist in finding key documents quickly.

Increased Worker Productivity & Improved Enterprise Collaboration

  • Collaborative tools and role-specific dashboards allow users to perform their key tasks quickly with appropriate inputs from others.

Enhances accuracy
and compliance

  • Reduces the number of errors as a result of using the wrong version of a document, increases traceability and accountability, accelerates the verification, approval, and distribution of documents, keeps documents in a secure vault.

ECM XD Modules & Components

Document Management System

The ECM XD is a secure web-based system that offers out-of-the-box compliance without customization.  ECM XD provides full versioning, a flexible folder/file structure; workflow-based collaborative document review, approvals, and distributions; full-text searches and notifications.  It allows drag and drop and with the integration with the workflow engine, the user can drop a file into a field on a workflow and it can be auto-filed in the folder structure.

  • Electronic Content Management for version control, security, centralized search, and history
  • Multiple views (structures) of the files in the ECM XD structure.
  • Document Types for classification of document metadata.
  • PDF rendering with stamping schema
  • Upload documents
  • Document training records
  • Powerful, securable dashboards with lists, charts, and favorites workflows for the periodic review, review, approval, publishing, and expiry of documents.

Document Change Control

ECM XD provides a configurable document change control process from request through each phase of the document life-cycle through publishing.

Document Metadata

The document properties include out-of-the-box metadata that can be configured to provide additional customer-specific fields. The documents can be linked to their relevant locations and other impacted documents.

Document Files and Taxonomy – Folder Structure

The intelligent tagging of content metadata to allow auto-filing in the content structure along with full-text searches and smart views allows customers to find documents rapidly.

Multiple views (structures) of the files in the ECM XD structure. Document workflows and integrated Training workflows

Allows hierarchical folder structure to file documents but is not required for organizations who do not use the folder approach.

Document Types

The system provides a document types module which allows users to set document metadata, numbering, and participant information at a higher level.

This enhances ease of maintenance for changing document behavior over a set of documents.

PDF Importer and Annotation Services Module

The annotation Module allows PDF documents to be scanned and annotated along with the collection of relevant metadata. These documents can be distributed in combination with e-mails.

Contract/Template Compliance – Predictive Compliance

Xybion Predictive compliance modules provide the capability for the uploading of documents and routing them through a process to compare their content and structure per approved company business rules and templates. This powerful capability can identify deviations from approved templates automatically and analyze certain data to determine productivity.

Integration and Indexing with 3rd party sources

The indexing module allows the company to upload documents from external sources, index and process them following a set of rules and run them through a workflow process and pass data back to the third-party source.

Competency Management

The skill/competency and training record management solution is a web-based solution that allows organizations to comply with current training regulations by identifying all the required skills and needed training per each job role. Manage, track, and report against online training, offline training, classroom training sessions, and all other training activities. Provides online examinations and extensive management reporting for easy assessment of an individual’s performance and the evaluation of overall training effectiveness.

  • Training Activities – create tasks to take /complete training.
  • Training Records – One place to view all training acquired by a person.
  • Job Role/Training Matrix – required training automatically assigned once user added to the role.
  • Skills – skills acquired by training.
  • Courses – courses are given to acquire training

External Systems Integration

The core platform comes with features that promote integration with external systems thereby leveraging the company’s IT investments. These powerful time-saving capabilities can be enabled with assistance from Xybion’s experienced professional services team. Active Directory Integration, E-mail integration, website integration, and external system and database integration. Both push and pull from the external sources have been done, on a synchronized schedule and in real-time.

Integrate With:

  • HR systems
  • ERP systems
  • External fields  – link to third party databases to pull information
  • System tasks – pull/push data from/to external databases.
  • API Launch – pull data from an external database based on a trigger and start a process/filling the form.
  • Synchro – import data from external databases on a schedule.

Tools & Components

PDF Converter

Add-on tool for rendering documents. Includes capabilities for watermarking, headers/footers, signature pages.

System Records

Report Mapping supports the capability to drop in report templates in Word and excel with mapping to the fields to generate reports in other modules.

Integration Framework

Active Directory, E-mail, and website integration. Both push and pull allowed the targeted master system to retain control over its data.

Federated Records Management

Xybion’s Federated Records Management (FRM) solutions provide powerful records management and federation capabilities for companies and help you better manage the massive amounts of content in your infrastructure. FRM will connect your legacy ECM systems with today’s leading content repositories.

  • The cost of storage is decreasing while the cost of protecting and maintaining records integrity is increasing.
  • Data must be maintained and archived for longer periods.
  • The amount of user/employee-generated data is exploding at an alarming rate.
  • Most companies manage data repositories in an ad-hoc manner.

Xybion Federated Records Management alleviates many of these critical issues by providing a true Federated solution for managing “in-place” data and content repositories. Using a market-leading data management solution, combined with industry best practices and experienced professional services, Xybion’s FRM is the right solution when terabytes of critical content are on the line. FRM provides the following key functions:

Federated search and retrieval

Conduct a single federated search across multiple disparate repositories.

Uniform policy management

Apply key records management policies such as records disposition and hold consistently across all record & content management systems.

Comprehensive records management

Manage file plans, retention schedules, and record disposition across multiple repositories.

Leverage native content repositories

Leverage existing records and content stores by leaving the content in its native repository and create aliases of each record.

Manage Training Activities

ECM XD’s training module enables to build of training activity workflows, OTJ workflows, and competency-related workloads to track acquired training by an individual or as a group. It enables role-based training and reports gaps as well. It also enables the administration of tests and quizzes. Following screenshots are examples of these capabilities already available Out-of-the-box.

Manage Training Processes

  • Skill Management by individual and by group
  • Identification and monitoring of training needs
  • Process requests, approvals, and registrations

Built-In Regulatory Controls

Embedded PDF rendering and annotation capabilities

File Format Neutral

Constraints can be set to restrict upload of potentially harmful file types, but the system otherwise is file format neutral

Configurable Document Folder Structure

Powerful, Integrated Document Workflow Capability

Out-of-the-box document workflows for periodic review, collaborative review, approval, publishing, training, and expiry.

Advanced Search and Retrieval Capability

Comprehensive Library Services (Version Control)

The standard check-in/check-out feature provides controlled secure access and flexible revision capabilities, history showing document revision history, and document workflow information.

Document Import & Export

Regulatory Compliance

Supports electronic signatures, records archival, and reporting.

Comprehensive Reporting

Auto-generation of formatted reports with ingested system data that can be edited on screen or sent to other formats such as Word or PDF for utilization.

Seamless Integration with Desktop Productivity Applications

Configurable e-mail notifications sent to MS Outlook or other MAPI compliant email systems and tasks to alert affected users of periodic reviews, document tasks, and changes in the document status.

Collaborative Document Lifecycle Process

Multiple reviewers can collaborate with comments and document markups.

User Management, Roles, and Security

Configurable Dashboards

Document Taxonomy

Audit Trail & Administrative Controls

Admins have full control over the audit trail.

Predictive Compliance Capabilities

Automated review and predictive compliance of documents vs templates.

Enterprise Content & Data Migration

An essential element of an effective enterprise content management strategy is the ability to consolidate, migrate, and securely deliver enterprise content. ECM XD manages all aspects of your content management strategy including content security, metadata, and enterprise collaboration. Built-in capabilities allow organizations to connect existing enterprise repositories, federate content, integrate systems, replicate critical data and migrate legacy repositories.

Ready to learn more? Book a free demo.

Receive documents in multiple formats, including paper, e-fax, SFTP and email attachments. Drop the documents into a shared drive and digitize through an automated OCR process. Keep detailed history of all changes. 

Associated documents, records, tasks or workflows. Assign to a user or user group. Monitor status of individual tasks on a searchable monitoring panel

Dual ID & Password: Non-Biometric e-Signatures: Time out Security Expiration. Enforce the uniqueness of each user ID and password combination for authentication. Use of e-signatures comprised of a secure user ID/password combination.

Allow users to configure private tags on documents to find them more rapidly.

Linked to email. Document tasks are sent to a centralized workload engine and notification of status and other events are distributed to user’s email to facilitate timely completion of critical document activities.

All electronic records include full signature manifestation with printed name of singer, time/date stamps and meaning of signature.

Allow users to embed internal document hyperlinks to support key regulatory processes requiring internal document links.     

Confirms to ISO 9001:2008 Quality Management System – requirements. Software enforces procedures for record identification, storage, protection, retrieval, retention time, and disposition (disposal).

Smart tags allow bulk changes across multiple documents. Metadata tags allow bulk import and export.

Automates review and predictive compliance of submitted documents versus established company templates.

Enables multiple reviewers to collaborate with comments and document markups

Heidi Krueger

Head of Quality Assurance

Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.

James Castonguay

Product Technology Lead

James provides leadership to Xybion quality management systems including product design, development and client delivery. James started working with Xybion in 2002 in its Canadian division. He is now managing product delivery from the United States. James has a master’s degree in mathematics and minor in informatics from the University of Sherbrook, Quebec, Canada.

Dave Chiaramonte

Enterprise Assets and HSE Leader
Dave brings diverse and deep expertise to his leadership role as the leader of Enterprise Asset Management (EAM) and Employee Health & Safety line of business. Dave has over twenty years of experience within the Information Technology industry including development, implementation and integration of complex Enterprise Systems in large corporate environments. He is a highly regarded technology leader in IBM’s Maximo Asset Management Product implementation. Dave worked with BMS and Dupont pharmaceuticals before joining Xybion in 2004.

Tom Klapmuts

Digital Lab Solution Leader

Tom provides leadership in design, delivery and revenue growth of Xybion digital lab solutions. He is an experienced client solutions manager with a demonstrated history of working with many clients globally to solve their business problems. Tom has training in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Life Sciences, CRO Management, and Clinical Development. Before joining Xybion, Tom worked for pharmaceutical companies such as Merck and Schering Plough. Tom is a Purdue university alumnus.

Priya Rajesh

Head of Sales: APAC & EMEA

Priya is responsible for Xybion business growth in APAC and EMEA region. She brings over 18 years of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.

Raji Bijur

Head of Quality Control & CSV

Raji leads Xybion Quality Control function. She has over 22 years of experience in software quality management, CSV, SQA, software process & KPI development and industry benchmarking. She has strong process implementation knowledge including ISO, CMMI, Agile, Scrum, Six Sigma, Lean. Certified CSQA, CSV, GCP, and GAMP. Raji has led implementation of QC processes in Robotic Process Automation (RPA) projects. Before coming to Xybion in 2019, she worked with IQVIA (Former Quintiles), Infosys, Aris Global, Mphasis and serving clients across different market segments. Raji has a bachelor’s degree in information science & technology and MBA from Indian Institute of Management, Ahmedabad.

Bob Friedman

Chief Solution Architect

Bob Friedman has over 25 years of experience in Preclinical information systems at Xybion Corporation as a developer, development manager and Chief Solution Architect. He has been an active member of the CDISC SEND standards consortium for five years as well as the PhUSE / FDA Industry Collaboration. Bob has previously worked for Synthes Orthopedics, NYU Medical Center and the New York State Department of Health. He has a master’s degree in Biomedical Engineering from Rensselaer Polytechnic Institute.

Gokul Panda

Head of Platform and Product Development

Gokul is the Head of Platform and Product Development, responsible for developing new and critical platforms and products. He has over 20 years of enterprise software development in the life sciences industry and related fields. Gokul holds both a Bachelor’s Degree and Master’s Degree in Engineering from the Indian Institute of Engineering, Science, and Technology. Gokul’s unrivaled expertise in enterprise software architecture and solutions provides Xybion’s clients with leading product functionality, innovation, and platform stability.

Anu Roy

Chief Solutions Delivery Officer

Anu manages project delivery and relationship. She has over 18 years of Life Sciences industry and IT services experience. Anu has a strong track record of designing and developing digital solutions, management consulting, quality & compliance Management, CLM, process & key metrics design, program execution & improvement and account management. Anu is a recipient of the STEM WOC ‘Technology Rising Star ‘by US Women’s magazine in 2014. She has received several other awards including Infosys Consulting Architect Award for outstanding achievement in 2011, RCL Crown Golden Brain Award in 2013. Anu is a guest columnist at Pharmaceutical Compliance Monitor and published in several international business magazines. Anu has a bachelor’s degree in Biochemistry and MBA in marketing.

Keith Dempsey

Chief Information Officer

Keith Dempsey has joined Xybion as our global CIO. He brings 20+ years of progressive Information Technology experience from Merck, AIG, Barclays and PriceWaterhouse. Focusing his career on building global strategies that capitalize on progressive technologies that scale in accordance to realized business growth. His experiences range from introducing new technologies that facilitated a competitive advantage for Merck, introduced new and scalable technologies for AIG Investments, and created progressive global organizational improvements for Barclay’s Capital. Keith has a degree in Chemical Engineering from Clarkson University and an MBA from William Paterson University.

Steve Porfano

Executive Vice President & Chief Financial Officer

Steve manages Xybion corporate function which includes Finance, HR, Legal and QA. Steve joined Xybion in 1989 as Corporate Controller and was promoted to Chief Financial Officer in 1991. As Chief Financial Officer, Steve is responsible for the establishment, enhancement, coordination and administration of the Company’s financial systems, internal controls, and related areas. Additionally, he is the corporate liaison to the Company’s bank, independent certified public accounting firm and governmental compliance and financial auditors.

Kamal Biswas

President & Chief Operating Officer

Kamal joined Xybion as its President and Chief Operating Officer in 2018. He is an acknowledged leader in the life sciences industry and has over 20 years’ experience in management consulting and pharmaceutical business. Very recently, Kamal was a Partner and leader of the global Life Sciences practice at Infosys Consulting. Before that, he spent several years working with pharma companies including Novartis Pharma and Ciba Geigy to manage manufacturing and late-stage R&D functions.

Pradip K. Banerjee, Ph.D., MBA

Chairman of the Board & Chief Executive Officer

Dr. Banerjee is an entrepreneurial senior executive with 30+ years of in-depth experience in the global Life Sciences, Healthcare and Services industry in global operations, strategic management, business development, investments and new ventures creation, M&A and Buy-outs. Prior to acquiring Xybion in 2008, Pradip served as President and CEO of Science Center in Philadelphia focused on creating, incubating, managing and investing in science based new companies. He was the Partner-in-Charge of the pharmaceutical Research & Development unit of Accenture where he created the R&D consulting unit and had grown it to become $100+ million worldwide business. Dr. Banerjee holds a Ph.D. in Pharmaceutical Sciences from University of Wisconsin-Madison and an MBA from the Wharton Business School of University of Pennsylvania.

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