Quality & Trust Center

Quality Management System

GxPReady operates under an established Quality Management System with approved procedures governing key activities related to the development, operation, implementation, and support of the GxPReady platform.

Controlled quality processes address areas including:

• Software lifecycle management
• System validation
• Configuration management
• Change control
• Training
• Document control
• Customer onboarding
• Testing and production readiness
• Ongoing system support

GxPReady's quality processes are maintained by professionals with direct experience working in pharmaceutical and other regulated life-sciences environments.

Built by Life-Sciences Practitioners

GxPReady is developed and supported by professionals with backgrounds across pharmaceutical Quality Assurance, Engineering, Validation, Calibration, Metrology, and regulated computerized systems.

Our experience working with a variety of systems and regulated organizations helps keep GxPReady focused on practical solutions to real-world GxP operational challenges.

We recognize that no single system is right for every application. GxPReady is purpose-built for organizations seeking a streamlined approach to managing equipment, calibration, maintenance, validation, and related regulated records.

Validation & Flash Validation™

GxPReady's patented Flash Validation methodology is based on decades of computer system qualification and development experience and significantly reduces the time and effort required to qualify this system while maintaining traceability, control, and documented verification.

The Flash Validation process maintains traceability from defined user requirements through configuration and qualification testing, helping customers establish documented evidence that the configured system supports its intended use.

Each implementation follows a controlled onboarding process that includes configuration, testing, training, change control, system setup, and preparation for production use.

21 CFR Part 11 & EU Annex 11

GxPReady maintains a detailed assessment of applicable requirements contained in 21 CFR Part 11 and EU GMP Annex 11.

The assessment addresses requirements point by point and identifies, as applicable:

• Relevant regulatory requirement
• GxPReady system control
• Supporting quality or validation process
• Verification or testing evidence
• Customer procedural responsibilities

This approach recognizes that compliant operation depends on both appropriate system controls and the procedures established by the regulated customer for its intended use.

Electronic Records & Signatures

GxPReady supports authenticated electronic record changes using unique user credentials. Applicable record changes are documented through the audit trail, including the user, date and time, and reason for the change.

Review or approval activities may also be documented within GxPReady records and authenticated when the record is saved. Externally generated electronically signed documents, including signed PDFs, can be retained as attachments to the associated GxPReady record.

Additional information about GxPReady electronic record controls, authenticated actions, and signature workflows is available on our 21 CFR Part 11 compliance page .

Security & Infrastructure

GxPReady uses established cloud and internet-security technologies as part of a layered approach to application availability, security, and resilience.

Microsoft Azure

GxPReady uses Microsoft Azure for cloud infrastructure and supporting platform services. Azure provides the underlying cloud infrastructure on which GxPReady operates.

Cloudflare

GxPReady also uses Cloudflare technologies to provide additional internet-facing security and resilience for the application environment.

GxPReady Application Controls

Infrastructure-provider capabilities operate alongside controls managed directly by GxPReady, including areas such as:

• Application security
• User access and role management
• System configuration
• Audit trails
• Validation
• Change management
• Backup configuration
• Monitoring
• Quality and operational procedures

GxPReady follows a shared-responsibility approach in which cloud and security-provider controls are supplemented by GxPReady-specific application, quality, and operational controls.

Backup, Redundancy & Business Continuity

GxPReady maintains documented practices supporting data protection, system resilience, backup, recovery, and continuity of operations.

These controls are designed to support the availability and protection of regulated records throughout the operational lifecycle of the system.

Detailed backup, recovery, and continuity information may be provided to qualified customers as part of supplier qualification or security review.

Controlled Customer Onboarding

GxPReady implementations follow a documented onboarding process designed specifically for regulated environments.

Depending on the customer's intended use and implementation scope, onboarding activities may include:

• System configuration
• User and role setup
• Requirements confirmation
• Qualification testing
• Validation documentation
• Training
• Change control
• Production readiness review
• Controlled system turnover

Customer GMP Operating Support

Software controls are only one component of a compliant computerized system.

GxPReady provides customers with operating SOPs and procedural guidance intended to help organizations establish controlled use of the system within their own Quality Management System.

These materials can help customers address system administration, user management, record handling, calibration and maintenance workflows, and other operational responsibilities associated with regulated use.

Customers remain responsible for reviewing, approving, and adapting procedures according to their own intended use, regulatory obligations, and Quality Management System.

Experience Supporting Regulated Organizations

GxPReady has been used by regulated life-sciences organizations in environments subject to FDA oversight and inspection.

Our focus is to help customers maintain controlled, traceable, and readily retrievable equipment, calibration, maintenance, and validation records that support inspection readiness.

Supplier Qualification

We understand that regulated organizations are responsible for evaluating software suppliers according to intended use, system risk, and applicable quality requirements.

Qualified customers may request additional information supporting their supplier qualification process, including information related to:

• GxPReady's Quality Management System
• Validation methodology and documentation
• 21 CFR Part 11 and EU Annex 11 assessments
• System security and infrastructure
• Backup and business continuity practices
• Implementation and onboarding controls
• Change management
• Customer operating procedures