Document Management in Regulated Environments
In regulated environments, document management and control is essential to an effective quality management and regulatory compliant system. Organizations following manual and paper-based processes for managing policies and control documents are realizing that such approach is inefficient, costly, unsustainable and prone to a higher risk of non-compliance. Controlling quality means in large part controlling documentation such as SOPs, policies, and quality manuals. The inability to manage the increasing amount and number of content and documents can create a debilitating bottleneck in a growing enterprise.
InfoStrength’s Smart Enterprise Suite Document Management capabilities enables companies to adopt an electronic and automated approach to managing documents across the enterprise to ensure compliance with FDA 21 CFR Part 11 regulations, ISO quality standards, Sarbanes-Oxley Act requirements, and other regulatory requirements. The web based InfoStrength Smart Enterprise Suite provides a central repository to store and organize documents. Integrated collaboration and workflow tools can be used to access, create, modify, review, approve and electronically sign documents globally in a controlled manner. The reporting capabilities that track each document from origin to obsolescence gives users complete visibility into the system and satisfy the demands of the most rigorous auditor.
How InfoStrength Smart Enterprise Suite can Benefit You
- Maintain a central, secure repository for efficient storage and access to control documents, policies and procedures
- Improve communication and teamwork across departments and functional areas
- Gain enterprise-wide visibility into document status with measurable performance metrics
- Lower cost of regulatory compliance (such as FDA 21 CFR Part 11) with electronic documents and electronic signatures, version control, audit trails, and the ability to manage permissions regarding the access and management of critical content that ensures complete control over that content
Document Management Facts
- InfoStrength Smart Enterprise Suite has been successfully implemented, validated and inspected in FDA environments without any instances of non-compliance since its introduction
- Dramatically reduces the time it takes to bring a new product to market by speeding up the process for document change, approval, notification, and distribution
- Is an off-the-shelf configurable product designed for rapid installation, implementation, and validation
- Ensures documentation integrity so employees always have the most updated document at their fingertips
Core Capabilities
- Combines powerful electronic routing and approval
- Full audit trail and reporting
- Electronic signature management and control ensures compliance with the appropriate controls built into InfoStrength Smart Enterprise Suite
- Computer systems validation plan and implementation including
- Validation-ready for IQ (Software Installation Qualification) and OQ/PQ (Operational Qualification/Performance Qualification)
- Supports industry-standard databases
- Version control, check-in, check-out, lock
Main Document Management Features
- Revision Control:
InfoStrength provides automatic document revision control to ensure that current version of an SOP is clearly and easily available and with easy to use permissions settings to ensure that it is the only version available. When a user makes a change in the document the user must enter a reason for the change. The software tracks all changes made to the document.
- Solid Audit Trail:
Provides a secure, time-stamped audit trail exceeding 21 CFR Part 11 requirements. InfoStrength Smart Enterprise Suite records the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made. Audit trail reports are specifically designed to meet the needs of the most demanding auditor and the reports are easily modified to meet the auditor’s specific requests.
- Security:
21 CFR Part 11 emphasizes security practices that limit access to authorized users and holding them accountable for written policies. With InfoStrength’s Smart Enterprise Suite, documents are stored in virtual vaults located in a central database for access by authorized users only. The software automatically locks an account when unauthorized users attempt to login or electronically approve a document.
- Analytics and Reporting:
InfoStrength Smart Enterprise Suite advanced analytics and reporting capability provides standard and ad hoc reports that improve management oversight.
- Electronic Signatures:
With InfoStrength Smart Enterprise Suite, documents can be signed and approved electronically. Signature manifestation — name, date, time, reason and legal intent of electronic signature — can be bound to each document.
- Manage Different Document Types:
InfoStrength Smart Enterprise Suite is uniquely qualified to be the focal point of any compliance initiative because it can manage different documents-based processes and handle all types of documents regardless of the software used to create them.
- Easy Access:
InfoStrength Smart Enterprise Suite is Web-based so it can connect all employees involved in document and quality control from virtually anywhere. Provides a centralized repository for easy access, search, and retrieval of documents by all authorized users.
- Streamlines Collaboration:
Creating and revising documents as a team is easier because InfoStrength Smart Enterprise Suite provides a collaboration workspace that allows a user to see other people's input, avoiding duplication.
- Integrates with Other Applications:
InfoStrength Smart Enterprise Suite can integrate with other applications like ERP, accounting, and human resources applications to accommodate department needs.
- Reports Wizard:
In addition to the standard reports available out-of-the-box in the solution, end-users can build custom reports using the simple Reports Wizard without any programming. The solution also supports automated generation of reports in standard file formats.