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 is provided as a validated platform developed and maintained under controlled quality and software lifecycle processes. Customers therefore do not begin with an unvalidated software product and build a validation program from scratch.

Flash Validation™ is GxPReady's patented approach for efficiently qualifying the customer's configured implementation and documenting that the system is suitable for its intended use. It is not simply a name for conventional validation activities.

The approach is designed to leverage the validation work already performed on the GxPReady platform while focusing customer qualification effort on the elements that are specific to the customer's intended use, configuration, procedures, and operating environment.

Flash Validation™ does not always fit the assumptions people bring from conventional validation programs. We have found that the approach is best understood through a discussion of the underlying methodology, the validation already performed on the GxPReady platform, and the evidence used to qualify the customer's configured implementation.

Because the methodology and supporting validation approach are an important part of how GxPReady is implemented, we do not attempt to reduce Flash Validation™ to a generic checklist on this website. Organizations evaluating GxPReady are encouraged to contact us to discuss the validation approach, supporting documentation, and how it applies to their intended 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 operates using Microsoft Azure cloud infrastructure together with established internet-security technologies, including Cloudflare, as part of a layered approach to availability, security, and resilience.

These infrastructure services support, but do not replace, controls managed directly by GxPReady, including:

• Application security
• User access and role management
• System configuration
• Audit trails
• Validation
• Change management
• Backup and recovery
• 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, validation, and operational controls.

Additional infrastructure and security information may be provided to qualified customers as part of supplier qualification or security review.

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.

Data Integrity, Ownership, Retention & System Exit

GxPReady takes a comprehensive approach to regulated data that includes both system controls and the manner in which the software is used. Security is only one component of effective data governance. Data integrity also depends on controlled user access, appropriate roles and permissions, authenticated actions, audit trails, record review, backup and recovery, documented procedures, training, and appropriate customer oversight.

For regulated records, the objective is not only to protect information from unauthorized disclosure, but also to protect records from unauthorized modification, loss, or corruption and to maintain their accuracy, context, traceability, and availability throughout the record lifecycle.

Customer Data Ownership

Customer Data remains the property of the customer. GxPReady does not claim ownership of Customer Data. During the term of the applicable customer agreement, GxPReady maintains Customer Data using documented backup, recovery, security, and data-management procedures designed to support the protection and availability of regulated records.

Complete Electronic Data Export

Under GxPReady's standard customer agreement, customers are provided with a Customer Data Export Package upon termination or expiration. The package contains an electronic export of Customer Data maintained within the customer's GxPReady database in a commercially reasonable database format designed to preserve the data structures, relationships, and associated electronic information maintained by the system.

Depending on the records maintained in the system, Customer Data may include equipment, maintenance, calibration, and validation records; audit-trail information; electronic-signature information; review and approval information; attachments; record status information; and associated metadata.

Human-readable records, reports, or selected data may also be provided where reasonably practicable. These supplemental files can be useful for viewing and working with individual records, but they are not relied upon as the sole representation of the complete electronic record where additional structure, context, metadata, audit-trail information, or attachments must be preserved.

Secure Data Transfer

Customer Data Export Packages are provided using a secure electronic transfer method. GxPReady applies commercially reasonable safeguards designed to protect exported Customer Data against unauthorized access during preparation, temporary storage, and transmission.

The objective is to provide customers with a controlled method for receiving their regulated electronic records without relying on unsecured ad hoc transfer methods.

Retention and Retrieval After Termination

Under GxPReady's standard customer agreement, Customer Data remains available for retrieval for 90 calendar days following termination or expiration. Customers are responsible for determining the regulatory and business retention periods applicable to their records and for maintaining exported records after termination.

Extended data retention, additional exports, custom data conversion, migration assistance, or other transition services may be available and may be subject to additional fees.

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