End-to-End Validation & Compliance Solutions for Pharma & Biotech
With a decade of GMP expertise, we deliver commissioning, qualification, and Validation services aligned with FDA, MHRA, and cGMP standards.
Precision and Reliability in Every Validation
Novus Validation and Compliance Services specializes in the commissioning and qualification of pharmaceutical facilities, utilities, and equipment. We deliver comprehensive, audit-ready solutions that ensure regulatory compliance, operational efficiency, and consistent product quality—driven by precision and reliability in every validation.
Our expertise includes thermal mapping and validation of critical controlled environments and equipment, such as warehouses, incubators, refrigerators, freezers, cryogenic systems, autoclaves, and depyrogenation units.
We develop complete validation packages aligned with globally recognized standards, including ICH Quality guidelines and ISPE best practices. Our documentation is structured to fully support regulatory inspections while maintaining the highest level of quality assurance.
Our Services Include:
- User Requirement Specifications (URS)
- Qualification Documentation Packages
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Traceability Matrix Development
- Requalification Services
At Novus, we are committed to delivering precise, reliable, and compliant validation solutions tailored to the evolving needs of the pharmaceutical and life sciences industries.
Comprehensive Qualification
We provide end-to-end Commissioning & Qualification (C&Q) services to ensure your facilities, utilities, and equipment are GMP-compliant and inspection-ready.
What We Cover
- Facilities: Cleanrooms, HVAC, and environmental monitoring
- Utilities: PW/WFI, clean steam, gases, and utility systems
- Equipment: IQ/OQ/PQ
Our Approach
Risk-based, GMP-aligned execution following USFDA, EMA, WHO & ISPE guidelines, with a strong focus on data integrity and audit readiness.
Why Choose Us
Fast, compliant, and reliable validation support for pharma and biotech manufacturing facilities, from design to final qualification.
Expert Temperature Mapping
At Novus Validation and Compliance Services, we deliver expert temperature mapping with precision and reliability in every validation across critical controlled environments.
We validate cryogenic freezers, refrigerators, incubators, warehouses, autoclaves, and depyrogenation tunnels to ensure full thermal compliance and product integrity.
Covering a wide range from -150°C to +300°C, we provide accurate thermal profiling for both ultra-low temperature storage and high-temperature sterilization systems.
Our risk-based, GMP-aligned approach ensures audit-ready documentation, regulatory compliance, and complete confidence in thermal performance.
Audit-Ready Documentation
At Novus Validation and Compliance Services, every temperature mapping study is delivered with complete audit-ready documentation packages designed to meet USFDA, EMA, WHO, and GMP expectations.
Our documentation ensures full traceability, data integrity, and regulatory confidence across all controlled environments ranging from -150°C to +300°C.
What Our Documentation Includes:
- Approved Protocols (IQ/OQ/PQ as applicable)
- Detailed Study Design and Risk Assessment
- Calibrated Instrument Lists with Traceability Certificates
- Raw Data Records and Continuous Data Logs
- Graphical Thermal Mapping Reports and Heat/Cold Spot Analysis
- Deviations, Investigations, and CAPA (if applicable)
- Final Summary Report with Compliance Conclusion
Built for Inspection Confidence
Each package is structured to support regulatory inspections and internal audits, ensuring data is complete, traceable, and defensible at every stage.
Our Commitment
We deliver documentation that reflects precision and reliability in every validation, transforming temperature mapping into a fully compliant, audit-ready process.
Traceability and Compliance
At Novus Validation and Compliance Services, we ensure complete traceability and regulatory compliance across all validation activities, delivering confidence in every stage of your temperature mapping studies.
Our systems are designed to maintain end-to-end data integrity (ALCOA+), ensuring every result is accurate, traceable, and audit-ready.
Key Elements of Our Traceability System:
- Fully traceable calibrated instruments and reference standards
- Documented data lineage from raw data to final report
- Controlled versioning of protocols and reports
- Equipment and sensor calibration records with validity tracking
- Secure data storage with audit trail capability
Compliance Assurance:
- Aligned with USFDA, EMA, WHO, and GMP guidelines
- Risk-based validation approach following ISPE best practices
- Support for regulatory inspections and internal audits
- Structured documentation ensuring inspection readiness
Our Commitment:
We deliver precision and reliability in every validation, ensuring your processes are not only compliant but fully traceable, transparent, and defensible under regulatory scrutiny.
Get in touch
E-mail: Info@Novusvalidation.com
Address: 32 Lincoln Gdns, Lake Hiawatha, USA