GxP Readiness Kit for NMR | Compliant Pharma NMR Operations

Integrated

Software, qualification, documentation, samples, and support in one coordinated framework.

Ready

Inspection-ready workflows for QC, CMC, and Analytical Development teams.

Traceable

Audit trails, controlled access, and database-driven records support data integrity.

GxP NMR in Pharmaceutical Development and Manufacturing

NMR is an established analytical method used by pharmaceutical companies in GLP and GMP environments, with applications ranging from raw material acceptance to product release. In regulated laboratories, data integrity and instrument qualification are essential for maintaining reliable, traceable, and reviewable analytical records.

As NMR becomes part of regulated pharmaceutical workflows, laboratories need more than analytical performance. They need controlled access, audit trails, qualification support, validation documentation, and consistent workflows that help teams maintain inspection readiness while supporting daily laboratory productivity.

What is the Bruker GxP Readiness Kit?

The Bruker GxP Readiness Kit provides an integrated foundation for regulated NMR operation. It combines compliant software, qualification and validation support, certified samples, documentation, and expert implementation services in one coordinated framework.

For QC laboratories, this helps make inspection confidence part of routine operation. For Analytical Development teams, this supports regulatory-defensible data while preserving the flexibility needed for scientific investigation, method development, and complex modality support.

What’s in the Kit

Qualification and Validation. IQ and OQ protocols; Computer System Validation protocol; validation and GAMP certificates; 21 CFR Part 11 manual.
Ongoing Performance. PQ-supportive software for system suitability and certified samples for routine performance verification.
Compliant Software Platform. Enterprise software platform designed for compliant multi-instrument NMR operation, with formal 21 CFR Part 11 readiness documentation and a data integrity architecture that supports customer implementations under EU Annex 11 and other equivalent frameworks.
Delivery and Support. Installation and training by GxP-qualified Bruker engineers help support a structured implementation and minimize disruption to existing laboratory operations.

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Features

Integrated GxP Framework. Combines GxP-ready software, qualification support, certified samples, technical documentation, and installation by qualified Bruker engineers in one coordinated offering for regulated NMR operation.
Data Integrity Controls. Supports traceable and controlled data handling through audit trails, role-based user management, controlled access, electronic signature capabilities, approval workflows, and database-driven electronic records.
Qualification and Validation Support. Provides IQ/OQ/PQ protocols, Computer System Validation support, software manuals, 21 CFR Part 11 documentation, validation and GAMP certificates, and documented installation activities.
Scalable Architecture. Supports regulated NMR workflows for AVANCE NEO, NEO-X, and Fourier 80 configurations, including enterprise-ready options for multi-instrument and multi-site environments.
Ongoing Performance Support. Certified samples and PQ-supportive software help laboratories support routine performance verification and system suitability over time.

Benefits

Lower Implementation Complexity. Move away from fragmented compliance-supporting setups by bringing software, documentation, qualification support, certified samples, and expert services into one integrated foundation.

Reduced Regulatory Risk. Controlled, traceable, and standardized NMR workflows help Quality Assurance, validation, and laboratory teams prepare for audits and inspections with more complete records.

Greater Confidence in Analytical Data. Data integrity controls, audit trails, controlled access, and structured records help generate analytical data that can support quality decisions, submissions, and inspections.

Consistent Operation Across Users and Sites. Standardized workflows and enterprise-ready architecture help teams operate consistently across analysts, instruments, laboratories, and sites.

Better Use of Scientific Resources. By reducing manual documentation and disconnected data handling, the GxP Readiness Kit helps scientists spend more time on interpretation, impurity characterization, structure elucidation, troubleshooting, and method support.

Built for Two Regulated Lab Priorities

For Quality Control Teams

QC teams need predictable batch release, clean audit trails, fewer manual reconstruction efforts, and standardized execution across analysts, instruments, and sites. The GxP Readiness Kit helps support inspection readiness as an outcome of daily work, not as a separate preparation project.

For Analytical Development Teams

Analytical Development teams need scientific flexibility, regulatory-defensible data, and a scalable foundation that can support both exploratory and regulated workflows. The GxP Readiness Kit helps reduce the burden of assembling compliance infrastructure from separate components while supporting future-ready analytical operations.

Applications

Pharmaceutical Quality Control
CMC laboratories
Analytical Development
Manufacturing support
Raw material testing
Product release support
Stability and method-transfer environments
Regulated and non-regulated analytical workflows where data integrity and documentation are required

Webinars

New tools for Data Integrity (DI), compliance and good laboratory and manufacturing practices.

Virtual Launch

January 28, 2020

The Application of NMR for Drug Development and Manufacturing in a Good Manufacturing Practice Setting

Good Manufacturing Practice GMP refers to the practices a manufacturer must conform to in order to meet the regulations set by agencies that control a

Testimonials

Cassie Yang, Principal Research Scientist at Abbvie

“The Fourier 80 has facilitated the implementation of workflows for controlling the quality of our incoming materials. It offers a simpler and cost-efficient alternative to high-field NMR systems. Combined with the intuitive interface of Mdrive, our non-expert users can directly submit their samples and retrieve their data with ease, while ensuring data integrity. As analysts, our role now only involves validating the final results. With no maintenance requirements, utilizing the Fourier 80 for our quality control applications has thus allowed us to both save time on high-field instruments and reduce the workload of our analytical team. This way, as experts, we can focus on addressing more demanding analytical challenges, while our users independently perform their QC analysis on raw materials.”

More Information

Compatibility & Configurations

The GxP Readiness Kit is available for all Bruker NMR spectrometer generations. The configuration is chosen by console, with optional add-ons for enhanced data acquisition and workflow integration.

Current GxP Readiness Kit, powered by TopSpin GxP, available for:

AVANCE NEO and AVANCE NEO-X, equipped with liquid or solid probes
Fourier 80

Optional add-ons for the current kit:

Mdrive (AVANCE NEO, AVANCE NEO-X, Fourier 80): A data acquisition user interface layered on top of TopSpin GxP. It consolidates electronic records and NMR data into a single database, providing a closed-system data repository where records are preserved as immutable, versioned entries, accessible and reviewable only by authorized users, with full traceability and controlled access.
ACP (AVANCE NEO, AVANCE NEO-X, Fourier 80): Automation and sample-handling option for regulated workflows on the current kit.
GoScan GxP (Fourier 80): A dedicated compliant workflow solution for the Fourier 80 benchtop system.

Legacy GxP Readiness Kit, powered by TopSpin 3, available for:

AVANCE III and AVANCE III HD

Related Products

FAQ

The Bruker GxP Readiness Kit is an integrated offering for regulated NMR operation. It combines compliant software, qualification support, validation documentation, certified samples, and Bruker implementation services in one coordinated framework.

The kit is designed for pharmaceutical QC, CMC, manufacturing, and Analytical Development teams that need traceable, audit-ready, and regulatory-defensible NMR workflows.

The kit supports data integrity through audit trails, controlled access, role-based user management, approval workflows, electronic records, and database-driven data handling.

For QC laboratories, the kit supports inspection readiness, standardized execution, traceable records, and more consistent operation across analysts, instruments, and sites.

For Analytical Development teams, the kit supports regulatory-defensible data, reduced compliance burden, and a scalable NMR foundation for both exploratory and regulated analytical work.

No. Compliance depends on the customer’s quality system, procedures, validation, training, change control, and routine use. Bruker provides technical capabilities, documentation support, certified samples, and qualified engineering support that help customers establish and maintain compliant NMR operation.

Support

LabScape

Service & Life Cycle Support for Magnetic Resonance and Preclinical Imaging

Bruker’s commitment to provide customers with unparalleled help throughout the buying cycle, from initial inquiry to evaluation, installation, and the lifetime of the instrument is now characterized by the LabScape service concept.

LabScape Maintenance Agreements, On-Site On-Demand and Enhance Your Lab are designed to offer a new approach to maintenance and service for the modern laboratory