Document Control Systems for FDA and ISO Regulations
Document management and control is essential to an effective quality management and regulatory compliant system. The demands for effective document management control grow as your product pipeline expands and approaches your commercialization goals. Meet the challenge head on by managing information across your entire operation to ensure FDA and ISO regulatory compliance with:
- FDA 21 CFR Part 11 regulations
- ISO quality standards
- Sarbanes-Oxley Act requirements
- And other regulatory requirements
InfoStrength empowers you with a central repository for all of your critical business information so you can:
- Create a searchable library of business and regulatory documents
- Organize and control critical content ,
- Demonstrate authenticity and non-repudiation
- Improve communication and teamwork across departments and teams
- Lower the cost of FDA regulatory compliance with electronic documents, e-signatures, version control, audit trails and the ability to manage permissions to critical content
Why InfoStrength is the right choice for your document management :
- Successfully validated and inspected in FDA environments
- Dramatically reduces the time it takes to bring a new product to market by accelerating the process for document change, approval, notification and distribution
- Easily configurable Software as a Service (SaaS) tool designed for rapid implementation and validation
- Choose to add On-Call Quality Support services to ensure your medical device or pharmaceutical QMS remains compliant
Document Management features include:
Improve document management with automatic revision control to ensure the most current version of your content is easily accessible – with easy to use permissions settings.
InfoStrength tracks all changes in your documents for you!
Solid Audit Trails
Achieve greater success with secure, time-stamped audit trails that exceed 21 CFR Part11 requirements.
InfoStrength records the identity of anyone who creates or modifies an electronic record, when the action occurred and what the changes were – automatically.
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 requests.
Store documents in virtual vaults that are only accessible by authorized users.
InfoStrength automatically locks an account when unauthorized users attempt to login or electronically approve a document, supporting 21 CFR Part 11 security requirements.
Analytics and Reporting
Guide mission critical business decisions with advanced analytics and reporting capabilities by using both standard and ad hoc reports.
Sign and approve documents electronically. Signature manifestation – name, date, time, reason and legal intent of the electronic signature – are bound to each document for ultimate security and auditability.
Management of Different Document Types
Successfully manage different documents-based processes and handle all types of documents – regardless of the software used to create them.
Easily create and revise documents as a team with InfoStrength’s collaborative workspace. Avoid duplicating efforts because your team has a 360 degree view of their projects.
Easy-to-Use Reporting Wizards
Build your own custom reports with the easy-to-use Reporting Wizard… no programming needed!
Don't have time to do all the document management required?
Add Document Management Assistance with our On-Call Quality Support to take the hassle out of your regulatory document management. Contact the regulatory document specialists at InfoStrength today to get started.