Real-Time Compliance Monitoring Software

Ensure Data Integrity and 21 CFR Part 11 Compliance

For pharmaceutical companies operating in controlled GxP environments, making sure that all systems remain in 21 CFR Part 11 compliance is not just important – it’s imperative. With Compliance Builder, you can seamlessly manage electronic document and signature control compliance across all IT sub-systems.

With comprehensive security features, such as user access control, data security, audit trails, and a central data archive, companies can prevent unauthorized use, including file/data deletion or modification.

Compliance Builder is a One-Stop Solution for Monitoring Business-critical Information and Systems.

ALCOA Data Integration

The FDA requires that all data submitted to the administration is reliable and accurate. Compliance Builder supports all elements of the acronym ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) to ensure data integrity.

Superior Audit Trails

By generating an audit trail and enabling electronic signatures, Compliance Builder serves as an audit management system that allows you to securely track changes across all IT subsystems including:

Upon detecting a file change, Compliance Builder stores the file revision in a unique, secure data repository for ready retrieval of revision history.

Top-Notch Application Security

Compliance Builder brings application security to a new level through a security wrapper that is placed around the application and file storage area. The software offers complete flexibility in establishing managed folder criteria by:

Specific Directory

Workstation

File Type

File Server

Out-of-the-Box Functionality

Audit Trail

Alerts & Email Notifications

Access Control

Database
Monitoring

Electronic Signatures

Disable Function at user & Domain Level

Dashboard

Version History &
File Deletion Control

Support for Any Size Program

Compliance Builder is offered in different license models. We’ll help you select the version that works best based on whether you need to manage compliance in one system, across multiple sites, or an entire enterprise — whether it is on a file system (any file type including Word, Excel, or any data file), a database such as SQL Server, Oracle or MS Access, or any instrument (Instron, UV-VIS, Special Microscope, Chemstation, and more).

Compliance Builder 10.0

Real-Time Compliance Monitoring Software that Ensures Data Integrity

Xybion Corporation’s upgraded Compliance Builder v10.0 enhances and facilitates real-time compliance monitoring services with improved access control, audit trail, and multi-language support features (including Mandarin), thus enabling global life science organizations to leverage new business opportunities.

The new version prevents any data loss due to accidental/intentional file deletion by users when directories are being monitored through the File Deletion Control feature. Further, this functionality is supported by modified Access Control which allows only a designated and authorized user to close the events with enhanced e-signature facilities.

An audit report with session duration information is automatically generated by login/log-out activity when the screen lock function is used. This allows the user to perform reconciliation of an event signoff timeout.

The additional features of CB v10.0 enable organizations to enhance the monitoring and tracking of 21 CFR Part 11 compliance, reducing enterprise regulatory risk.

Key Features in Compliance Builder 10.0 (Data Integrity Software)

Multilingual Support

Multi-lingual functionality is one of the best new features of CB 10.0. A simplified Chinese language pack is included, and other language packs can be added on demand.

File Deletion Control

Prevent files from being accidentally or intentionally deleted by users while accessing the directories through a Secure Application feature.

Audit Trail

Generate an audit report based on specific data events, such as data creation, deletion, or modification, and with login/log-out session with duration information.

21 CFR Part 11

Configure the meaning of e-signatures for data events through Picklist. This can be monitored through an audit trail to prevent super users (like Admin) from changing the choice of Picklist later.

Additional Support for New Releases on Operating System (OS) and Databases

Database Versions where support continued, and new versions added:

  • Oracle 12c
  • Oracle 11g
  • MS SQL Server 2016
  • MS SQL Server 2014
  • MS Access 2010
  • MS Access 2013
  • MS Access 2016

Operating System Versions where support continued, and new versions added:

  • Windows Server 2016
  • Standard Windows server 2012R
  • Windows 10
  • Windows 7

Browsers where support continued, and new versions added:

  • Google Chrome
  • Explorer 11
  • Internet Explorer 10

ALCOA Data Integrity

Data has always been important to life sciences companies involved in pharmaceutical manufacturing and research. The importance of data integrity is growing exponentially as regulatory requirements evolve. With Compliance Builder, you can safeguard your data and prove that it has not been compromised.

Compliance Builder lets you automatically conform to the principles of ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate).

Additional features of Compliance Builder that promote CFR Part 11 compliance include:

Comprehensive Application Security

Full Audit Trail

Validation-Ready Platform

Configurable Electronic Signatures

Real-time Database Compliance Monitoring

Compliance Builder includes built-in modules for monitoring files, databases, and SharePoint sites. Our database monitoring module allows you to manage and control any RDBMS-based system, including SQL-based applications, batch systems, and custom-developed database applications.

Our real-time database module facilitates monitoring all files Subject to 21 CFR part 11 regulations.

With the Compliance Builder database module, you can:

  • Monitor changes in database tables, recording each change event and maintaining an archive of all changed records.
  • Configure the system to issue and route data change notifications.
  • Require authenticated acknowledgments and sign-offs.
  • Monitor data changes using various parameters with an easy-to-use, menu-driven user interface.

Audit tables and notifications

For each database table, Compliance Builder:

  • Creates a corresponding audit table that mirrors the structure of the monitored table.
  • Uses triggers to monitor target tables.
  • Transfers data changes to audit tables.
  • Sends notifications based on pre-configured rules.
  • Provides a “recreate” function to ensure audit tables are recreated (preserving the old audit table) if the structure of the table being monitored changes.

Reporting

With Compliance Builder, you get customizable reports that allow you to manage your business. Reports display data from monitored RDBMS records in both summary and detailed formats. You can optionally configure reports to display only selected database tables or fields, or simply the old/new values of the data that was changed.

Real-time File Compliance Monitoring

Compliance Builder includes built-in modules for monitoring files, databases, and SharePoint sites. Our out-of-the-box file monitoring module facilitates monitoring files subject to 21 CFR Part 11 regulations.

With the Compliance Builder File Compliance module, you can:

Import existing data from any file-based system

Quickly integrate desktop applications with legacy data sources

Facilitate compliance with 21 CFR Part 11

Compliance Builder gives you the ability to manage sensitive company data and protect your most valuable data assets.

When we say any file type, we mean it!

Compliance Builder is designed to monitor any type of file. Commonly monitored file types include:

  • Configuration Files
  • Excel Spreadsheets
  • Word Documents
  • Text files
  • PDFs
  • Graphic Files
  • All Microsoft Files
  • Recipe Files
  • Lab Instrument Data Files
  • PLC Programs
  • Access Databases
  • SAS Data Sets
  • Any File-based System
  • Databases
“Being able to track the lifecycle of desired files has repeatedly enabled my team to quickly resolve discrepancies saving valuable time in file forensics work and documentation.”
- Client Feedback

Key Features of Compliance Builder’s File Monitoring Module

Upon detecting a file change, Compliance Builder stores the file revision in a unique, secure data repository for ready retrieval of revision history.

File Version Comparison Tools

File Change Notifications

Browse Folders

Field Version Tracking

Flexible Managed Folders

Intuitive Folder Manager

Audit Trail Report

Multiplatform
Support

Real-time SharePoint Compliance Monitoring

If your organization relies on Microsoft SharePoint for enterprise storage of critical business data and associated files, Compliance Builder can help you achieve CFR Part 11 compliance and reduce operational risks by enabling the detection of abnormal activities.

With the Compliance Builder SharePoint module, you can:

Reduce Risk

Gather information stored in SharePoint and report on download activity for highly sensitive files.

Detect Fraud

Act on information quickly and prevent the misuse of critical information in SharePoint with real-time email alerts.

Increase Compliance

Prevent SharePoint users from exceeding the maximum number of downloads and monitor unusual activities via automated reporting features.

Easy Configuration Process

Compliance Builder enables you to monitor and audit SharePoint libraries. The SharePoint server configuration page enables you to configure the system to gather information regarding download activity and receive email alerts when threshold limits are exceeded.

Compliance Builder supports SharePoint versions 2007 and above and does not require installation on the SharePoint server. The software is seamlessly integrated with your routine IT ecosystem.

Ready to learn more? Book a free demo.

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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