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Regulatory Document Management

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:

Version Control

Solid Audit Trails

Security Features

Analytics and Reporting

Electronic Signatures

Management of Different Document Types

Streamlined Communication

Easy-to-Use Reporting Wizards


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.

Contact InfoStrength