GxP Documents

Toss the paper. Keep the compliance.
Gain a better way of working together.

Improve Quality Processes

with GxP Docs

Built for control. Designed for collaboration.

GxP Documents is a complete document management and control solution that supports the comprehensive document lifecycle—from creation, development, review, and publishing to change management and archival. Gain control of quality SOPs, validation documents, compliance documents, process specific instructions, analytic procedures, and more. All while amping up the secure, controlled collaboration your business requires.

Work securely with both internal teams and external partners following GxP guidelines and regulations, ISO standards, and maintaining 21 CFR Part 11 compliance.

Collaborate Effectively

Create documents, manage revisions, and route for sign-off, all while eliminating delays—whether team members are internal, external, or both. Our cloud-based collaborative workspace with role-based security ensures clear accountability and separation of responsibilities.

Control Securely

Manage critical business documents, knowing they are always available in a scaleable, digital locker that meets the most rigorous enterprise standards. GxP Documents is built on Microsoft Azure, known for comprehensive security and compliance, as well as scaleability. 

Work Confidently

GxP Documents is built on familiar Microsoft technologies, making it a seamless part of any user’s day-to-day experience.

Features and Benefits

Fundamentally improve the quality of your organization’s document management. 

Tight Document Control
  • Ensure consistent structure of documents using pre-defined and pre-configured document types
  • Manage and track documentation per GxP standards and regulations, ISO requirements, and meet 21 CFR Part 11 compliance
  • Support the complete document lifecycle from creation, collaboration and development, review and publishing to change management and archival
  • Assign and maintain clear separation of responsibilities, including owner, author, reader, approver, and etc.
  • Automatically generate document reference numbers based on user configuration and using predefined document taxonomy
  • Automatic PDF generation upon final document approval
Real-time Collaboration
  • Edit documents in Microsoft Office 365, allowing multiple users to work on the same document at the same time
  • Collaborate within the browser, view other users’ content instantly, and communicate in real time
  • Stay on top of the entire process as the document owner and monitor the progress and completion of tasks of each collaborator
  • Work easily across departments or externally with users in partner organizations like CMOs, CDMOs, 3PLs, etc.
  • Enjoy hassle-fee internal or external collaboration with full control and detailed progress tracking
Document Publishing with E-Signatures
  • Workflows can drive final approvals needed for publication
  • Comply with 21 CFR Part 11 which requires published documents to be electronically signed
  • Establish document ownership and accountability, ensuring quality standards of your organization are rigorously followed
  • Use configurable e-signature reason codes for document approval purposes and change management justifications
Complete Change Management
  • Leverage a fully automated workflow for managing changes to controlled documents
  • Ensure that people with appropriate responsibility are involved based on the severity and nature of the document change request
  • Track change request details including:
      • Thorough description and classification of change by priority, department, and other various criteria
      • The approval process of the change
Rich Audit Trail Reporting
  • Each time a draft is changed or saved, GxP Documents creates a new draft version of the document
  • In addition to the updated document content, document versions also provide information about the changes of document properties, and a list of activities that have been applied
  • Each piece of document history information is structured by an activity type, description, executor, and a date and time stamp, formatted in a human readable audit trail
  • All document and app audit trails are available at all times and can be exported as a PDF report
Controls for Printed Documents
  • Printed copies are automatically watermarked to avoid reliance on outdated copies
  • Printed copy watermarks include print date and printed by User

Securely Collaborate Across the Entire Life Cycle of GxP Documents

Unlimited Use Cases

There are limitless applications for GxP Documents because the solution not only works for all internal team members, but also enables you to securely collaborate with external partners—one of the biggest challenges facing life science organizations.

The chart below lists a few of the ways life science organizations are using GxP Documents today. View the fact sheet for a complete list.

Finance & Legal
  • Contracts and other legal documents
  • Sarbanes Oxley (SOX) and Sunshine Reporting
  • 10K, shareholder presentations and other reporting narrative aids
Human Resources
  • On-boarding, training, and cross-training
  • Separation / exit process documents
  • Job descriptions, salary and level templates, promotion form templates
  • Company handbook and other employee policy information
Customer Relations
  • Customer technical specifications intake forms and surveys
  • Customer (or partner) project deliverables
  • Sales and marketing collateral
Supply Chain Planning
  • Contracts for supplier CMO (contract manufacturing organizations) / CDMO (contract development and manufacturing organizations)
  • Vendor certifications
  • Vendor audit history / results
  • Vendor delivery commitments / schedules
Quality & Regulatory Compliance
  • Standard operating procedures (SOPs)
  • Employee certification requirements
  • Complaints
  • Investigations and CAPAs (Corrective Action Preventive Actions)
  • Electronic systems independent verification and validation (IVV)
Research & Development
  • Research findings
  • Internal and external peer review
  • R&D collaboration
  • Collaborative documentation, approvals and reviews with trial sites, CDMOs (contract development and manufacturing organizations), cell banks and other partners
Manufacturing Execution
  • Material testing / Inspection documents
  • Analytics methods standards
  • Employee training documentation
  • Batch production records
  • Equipment validation records
  • Equipment maintenance records
  • Equipment specifications and audits
  • Environmental controls logs and history
  • Non-conformances, deviations, corrections, Investigations
  • Batch release history
Inventory & Warehousing
  • Material inspection records
  • Material COAs
  • Material specifications
  • Batch track and trace records
  • Dispensing records
  • Shipping records
  • Material receipt records
  • Batch release history
Sourcing, Procurement, Materials & Management
  • Material inspection records
  • Material COAs
  • Material specifications
  • Batch track and trace records
  • Approved supplier lists
  • Supplier qualifications
  • Material receipt records
  • Batch release history
  • Employee training history
  • Internal audit history
  • Supplier audit history
  • Material testing / Inspection documents
  • Analytics methods standards

With GxP Documents there’s no reason to limit the traceability of approvals activity, to wait days or weeks for artifacts a contractor worked on, or to settle for a solution that can’t scale. And, because GxP Documents is built on the Microsoft Azure foundation, teams can collaborate with the confidence that security and accessibility meets enterprise standards. 

Ready to get started?

Resources for Improving Quality Processes

Free White Paper

Learn how a digital transformation within your organization to share quality incident data can help your organization Drive Speed to Market and Gain Operational Velocity.

Free Quality eBook

Learn what every quality leader should look for in a digital platform for pharma and biotech manufacturing.

Envisioning Workshop

Quality Controls Workshop

Meet with our experts to ideate together and jointly define how to improve your quality challenges like quality incidents, CAPAs, audits and planning, and more.