Meet the Circle of Quality for Sievers Instruments
We understand the pressure you're under — keeping instruments running reliably, staying compliant, and protecting your data integrity, all while minimizing downtime.
The Circle of Quality for Sievers Instruments is our answer. It provides flexible, specialized services including verification and validation, certified parts and consumables, preventative maintenance, repairs and expert-led failure analysis — all designed to support your facility's needs and challenges.
Our Circle of Quality is not just a commitment to quality, but a comprehensive system to optimize the performance and lifespan of your Sievers Instruments.
Not all instruments are created equal. Neither are all instrument services.
Support Throughout Your Instrument Lifecycle
Let's talk. Your success is our priority. We have solutions to get you up and running quickly, keep your instruments running reliably, maintain compliance, and protect data integrity.
Learn more about comprehensive support for your instrumentation.
Lifecycle Instrument Support
On-site training, calibration, and verification with direct service from your instrument manufacturer.
Why go direct? Choosing manufacturer-direct service ensures access to a level of specialization and technical knowledge that third-party providers cannot match.
- Qualification and Validation: On-site validation services (IQ/OQ/PQ) provide comprehensive documentation required for FDA, AIFA, and EMA audits.
- Proprietary Diagnostics and Training: Veolia’s specialized team of remote support and Sievers Field Service Engineers (FSEs) receive the most up-to-date proprietary training on new technologies, have access to software/firmware updates, and are equipped with specialized diagnostic software for rapid troubleshooting.
- On-Site Maintenance: Prioritized access to Sievers Certified FSEs with a Sievers Preventative Maintenance (PM) Service Plan.
Calibration and Maintenance for Compliance and Audit Readiness
Maintenance and calibration are not merely operational tasks. They are mandatory compliance activities.
- Regulatory Alignment: EU GMP Annex 15 and FDA guidance emphasize that maintenance and calibration instructions originate from the manufacturer. Utilizing unauthorized third parties can potentially invalidate an instrument's "state of control" and IQ validation.
- Regulatory Security: OEM-led validation (IQ/OQ/PQ) and maintenance ensure adherence to EU GMP Annex 15, FDA Process Validation Guidance, and compendial requirements (USP <643>, USP <645>, USP <1058>, USP <85>, USP <86>, JP 2.59).
- Documented State of Control: The FDA requires that critical quality control instruments be qualified, calibrated, and maintained according to manufacturer specifications to ensure the process remains in a state of control (21 CFR 211.100, 211.110, 211.68). During FDA, AIFA, or EMA audits, inspectors carefully evaluate whether critical instruments are maintained according to manufacturer specifications and whether complete traceability of maintenance and qualification activities can be demonstrated.
Priority Support to Prevent Unplanned Downtime
Our dedicated global organization supports analytical instrumentation across the world to minimize downtime and protect operational continuity.
Customers who choose Preventative Maintenance (PM) Service Plans for Sievers Instruments are guaranteed priority support. Additional plans offer even further expedited response times during critical emergencies. This commitment means operational continuity is safeguarded, minimizing potential downtime and protecting production and revenue.
Preventative maintenance activities typically include calibration, verification, and replacement of critical consumable parts such as UV lamps, pump heads, and resin beds.
Support for Sievers Instruments without a service plan through Veolia, or for customers utilizing unauthorized third-party services, are addressed on a best-effort basis and may incur additional costs.
Download Sievers Services Brochure for Life Sciences
Beyond standard maintenance, customizable add-on services allow facilities to address specific testing requirements. Examples include:
- Autosampler and Inorganic Carbon Remover (ICR) maintenance
- Conductivity calibration and linearity (USP <645>)
- System Suitability Checks (USP <643>)
- SDBS Suitability Checks (JP 2.59)
- Turbo and Multipoint calibration
Out-of-Specification (OOS) Investigation Support
When an OOS result occurs, our root cause analysis services and audit-ready documentation support faster investigations and closures.
When an Out-of-Specification (OOS) event or malfunction occurs, Veolia can support you with failure analysis services to identify the root cause. This is a unique benefit in contrast with unauthorized third-party service providers, which cannot provide an official and traceable failure analysis report to support your OOS investigation or audit documentation for FDA, EMA, or national regulatory authorities.
Veolia’s Failure Analysis Report (FAR) for Sievers Instruments provides critical advantages:
- Manufacturer-Led Analysis: Specialized Quality Engineering teams review production data, QC records, and data to identify exact root cause.
- Official Documentation: The FAR provides an official, traceable document for presentation during audits, demonstrating that the investigation followed ISO 9001 and ISO 17025 standards.
- Adequate Investigation: Using OEM Services to support root cause analysis and resolution of OOS results can help demonstrate adequate investigation aligned with 21 CFR 211.192.
Traceable Consumables For Data Integrity and Analytical Accuracy
Measurements are only as robust as the standards used for calibration and verification.
Sievers Certified Reference Standards are engineered to eliminate variability that generic alternatives struggle to replicate. These standards are USP, EP, and NIST traceable; notably, Sievers Standards produced at Veolia facilities are traceable to the International System of Units (SI), providing the ultimate global benchmark for measurement accuracy.
Certified Sievers Standards, Vials, and Consumables
How does Veolia’s manufacturing process for Sievers Standards, Vials, and Consumables ensure accuracy?
- ISO/IEC 17025 and ISO 17034 Accreditations: These certifications are essential for reference material production, but they must be viewed with nuance. ISO/IEC 17025 is only valid for specific activities within the accredited scope.
- Component Traceability: Quality is maintained by tracking individual components through the entire production lifecycle. This compliance monitoring ensures that any material used in a compendial test can be traced, providing a documented chain of custody.
- Contamination Control and Signal Suppression: Through advancements in materials science and specialized clean room conditions, background signal suppression is achieved for low-level reference materials. Low-level interference is common in generic or in-house produced TOC standards which can compromise measurement accuracy.
- Data Integrity: The use of authentic Sievers consumable parts and USP/NIST traceable reference standards significantly reduces measurement variability and establishes an audit trail for regulatory compliance.
Download - Why Traceability Matters
Download - Sievers Certified Reference Materials and Consumables Catalog
ISO Standards
Our commitment to ensuring your success through ISO-accredited quality, traceability, and continuous improvement.
Our service organization operates according to ISO 9001 and follows Operational Excellence methodologies. We maintain dedicated quality improvement teams, accreditations for ISO/IEC 17025 (Testing), and ISO 17034 accreditations for TOC reference material production. With traceability of key components throughout the entire production process, our commitment to quality assurance is unparalleled.
-
Lifecycle Instrument Support
Lifecycle Instrument Support
On-site training, calibration, and verification with direct service from your instrument manufacturer.
Why go direct? Choosing manufacturer-direct service ensures access to a level of specialization and technical knowledge that third-party providers cannot match.
- Qualification and Validation: On-site validation services (IQ/OQ/PQ) provide comprehensive documentation required for FDA, AIFA, and EMA audits.
- Proprietary Diagnostics and Training: Veolia’s specialized team of remote support and Sievers Field Service Engineers (FSEs) receive the most up-to-date proprietary training on new technologies, have access to software/firmware updates, and are equipped with specialized diagnostic software for rapid troubleshooting.
- On-Site Maintenance: Prioritized access to Sievers Certified FSEs with a Sievers Preventative Maintenance (PM) Service Plan.
-
Calibration and Maintenance for Compliance and Audit Readiness
Calibration and Maintenance for Compliance and Audit Readiness
Maintenance and calibration are not merely operational tasks. They are mandatory compliance activities.
- Regulatory Alignment: EU GMP Annex 15 and FDA guidance emphasize that maintenance and calibration instructions originate from the manufacturer. Utilizing unauthorized third parties can potentially invalidate an instrument's "state of control" and IQ validation.
- Regulatory Security: OEM-led validation (IQ/OQ/PQ) and maintenance ensure adherence to EU GMP Annex 15, FDA Process Validation Guidance, and compendial requirements (USP <643>, USP <645>, USP <1058>, USP <85>, USP <86>, JP 2.59).
- Documented State of Control: The FDA requires that critical quality control instruments be qualified, calibrated, and maintained according to manufacturer specifications to ensure the process remains in a state of control (21 CFR 211.100, 211.110, 211.68). During FDA, AIFA, or EMA audits, inspectors carefully evaluate whether critical instruments are maintained according to manufacturer specifications and whether complete traceability of maintenance and qualification activities can be demonstrated.
-
Priority Support to Prevent Unplanned Downtime
Priority Support to Prevent Unplanned Downtime
Our dedicated global organization supports analytical instrumentation across the world to minimize downtime and protect operational continuity.
Customers who choose Preventative Maintenance (PM) Service Plans for Sievers Instruments are guaranteed priority support. Additional plans offer even further expedited response times during critical emergencies. This commitment means operational continuity is safeguarded, minimizing potential downtime and protecting production and revenue.
Preventative maintenance activities typically include calibration, verification, and replacement of critical consumable parts such as UV lamps, pump heads, and resin beds.
Support for Sievers Instruments without a service plan through Veolia, or for customers utilizing unauthorized third-party services, are addressed on a best-effort basis and may incur additional costs.
Download Sievers Services Brochure for Life Sciences
Beyond standard maintenance, customizable add-on services allow facilities to address specific testing requirements. Examples include:
- Autosampler and Inorganic Carbon Remover (ICR) maintenance
- Conductivity calibration and linearity (USP <645>)
- System Suitability Checks (USP <643>)
- SDBS Suitability Checks (JP 2.59)
- Turbo and Multipoint calibration
-
Out-of-Specification (OOS) Investigation Support
Out-of-Specification (OOS) Investigation Support
When an OOS result occurs, our root cause analysis services and audit-ready documentation support faster investigations and closures.
When an Out-of-Specification (OOS) event or malfunction occurs, Veolia can support you with failure analysis services to identify the root cause. This is a unique benefit in contrast with unauthorized third-party service providers, which cannot provide an official and traceable failure analysis report to support your OOS investigation or audit documentation for FDA, EMA, or national regulatory authorities.
Veolia’s Failure Analysis Report (FAR) for Sievers Instruments provides critical advantages:
- Manufacturer-Led Analysis: Specialized Quality Engineering teams review production data, QC records, and data to identify exact root cause.
- Official Documentation: The FAR provides an official, traceable document for presentation during audits, demonstrating that the investigation followed ISO 9001 and ISO 17025 standards.
- Adequate Investigation: Using OEM Services to support root cause analysis and resolution of OOS results can help demonstrate adequate investigation aligned with 21 CFR 211.192.
-
Traceable Consumables For Data Integrity and Analytical Accuracy
Traceable Consumables For Data Integrity and Analytical Accuracy
Measurements are only as robust as the standards used for calibration and verification.
Sievers Certified Reference Standards are engineered to eliminate variability that generic alternatives struggle to replicate. These standards are USP, EP, and NIST traceable; notably, Sievers Standards produced at Veolia facilities are traceable to the International System of Units (SI), providing the ultimate global benchmark for measurement accuracy.
Certified Sievers Standards, Vials, and Consumables
How does Veolia’s manufacturing process for Sievers Standards, Vials, and Consumables ensure accuracy?
- ISO/IEC 17025 and ISO 17034 Accreditations: These certifications are essential for reference material production, but they must be viewed with nuance. ISO/IEC 17025 is only valid for specific activities within the accredited scope.
- Component Traceability: Quality is maintained by tracking individual components through the entire production lifecycle. This compliance monitoring ensures that any material used in a compendial test can be traced, providing a documented chain of custody.
- Contamination Control and Signal Suppression: Through advancements in materials science and specialized clean room conditions, background signal suppression is achieved for low-level reference materials. Low-level interference is common in generic or in-house produced TOC standards which can compromise measurement accuracy.
- Data Integrity: The use of authentic Sievers consumable parts and USP/NIST traceable reference standards significantly reduces measurement variability and establishes an audit trail for regulatory compliance.
Download - Why Traceability Matters
Download - Sievers Certified Reference Materials and Consumables Catalog
-
ISO Standards
ISO Standards
Our commitment to ensuring your success through ISO-accredited quality, traceability, and continuous improvement.
Our service organization operates according to ISO 9001 and follows Operational Excellence methodologies. We maintain dedicated quality improvement teams, accreditations for ISO/IEC 17025 (Testing), and ISO 17034 accreditations for TOC reference material production. With traceability of key components throughout the entire production process, our commitment to quality assurance is unparalleled.