Calibration Services for the Pharmaceutical and Medical Industry

Precision Calibration Services for Pharmaceuticals and Medical Manufacturing


The pharmaceutical and medical device industries operate under the most rigorous quality and safety standards in the world, where measurement accuracy directly determines drug efficacy, patient safety, and regulatory compliance. From drug development and clinical trials to large-scale manufacturing and quality control, pharmaceutical operations require precision measurement and validated instrumentation that ensures product purity, potency, and safety.

Quality Surveillance, Inc., backed by the trusted Accredited Labs network, provides specialized calibration services designed for the stringent requirements, comprehensive validation needs, and life-saving mission of pharmaceutical and medical device manufacturing.

The Critical Foundation of Drug Safety and Medical Device Reliability

Pharmaceutical and medical device manufacturing carries the ultimate responsibility for products that directly impact human health, where measurement errors can affect drug potency, compromise product safety, or render medical devices ineffective. A slight deviation in temperature during drug manufacturing can destroy active ingredients, inaccurate concentration measurements can affect drug efficacy, and improper calibration of medical device testing equipment can compromise device safety and performance. When measurement systems fail in pharmaceutical operations, the consequences can include product recalls, regulatory sanctions, patient harm, and loss of public trust.

The pharmaceutical industry operates under comprehensive regulatory frameworks including FDA regulations, ICH guidelines, and international standards that require validated measurement systems, complete documentation, and continuous compliance monitoring. Modern pharmaceutical manufacturing uses sophisticated process control, automated systems, and advanced analytics that depend on calibrated instruments for regulatory compliance and product quality.

Pharmaceutical Industry Standards and Regulatory Compliance


Food and Drug Administration (FDA) Regulations
Pharmaceutical manufacturing must comply with comprehensive FDA regulations including cGMP, validation requirements, and quality system standards. Our calibration services support FDA compliance and provide documentation for regulatory inspections and product approvals.

International Council for Harmonisation (ICH) Guidelines
Pharmaceutical development and manufacturing must comply with ICH guidelines for quality, safety, and efficacy that include analytical and manufacturing requirements. Our services support ICH compliance and international regulatory harmonization.

United States Pharmacopeia (USP) Standards
Pharmaceutical testing and analysis must comply with USP standards and compendial methods that specify testing requirements and acceptance criteria. Our calibration services ensure compliance with USP standards and support pharmacopeial testing requirements.

European Medicines Agency (EMA) Requirements
Pharmaceutical products marketed in Europe must comply with EMA requirements and European Union directives for quality and safety. Our calibration services support European regulatory compliance and international market access.

ISO 13485 Medical Device Quality Management
Medical device manufacturers must implement ISO 13485 quality management systems that require comprehensive calibration programs and measurement controls. Our services support ISO 13485 implementation and certification for medical device quality management.

Why Choose QSI for Pharmaceutical and Medical Calibration


ISO/IEC 17025 Accreditation and Pharmaceutical Industry Expertise

We operate under the rigorous ISO/IEC 17025 standard while maintaining specialized expertise in pharmaceutical regulations, cGMP requirements, and medical device standards. Our technicians understand pharmaceutical environments and provide calibration services that support regulatory compliance and product quality.

Regulatory Compliance Documentation and Audit Support
Pharmaceutical facilities require comprehensive calibration documentation for regulatory inspections and international audits. Our services provide detailed validation documentation, regulatory compliance support, and inspection preparation assistance.

Supply Chain and Multi-Site Coordination
Pharmaceutical companies often operate multiple facilities and complex supply chains that require coordinated calibration programs. We provide consistent service quality and documentation across multiple locations while supporting global pharmaceutical operations.

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Powered by Accredited Labs

As part of the Accredited Labs family, Quality Surveillance, Inc. combines local, personalized service with the resources and expertise of a national calibration network. This partnership ensures consistent quality, technical support, and the capabilities needed to handle your most challenging calibration requirements.

Personalized Customer Service

We believe in building long-term relationships with our customers. That's why we prioritize clear communication, consistency, and reliability. Our team takes time to understand your specific needs, applications, and challenges, so we can provide calibration solutions that support your operational goals and quality objectives.

ISO/IEC 17025 Accreditation

We operate under the rigorous ISO/IEC 17025 standard, which demonstrates our technical competence and quality management system. This internationally recognized accreditation means our calibration results are accurate, reliable, and globally accepted. Our technicians undergo continuous training in evolving technologies and techniques.

Comprehensive Documentation

We go beyond calibration certificates, providing you with the documentation and support your quality system needs. Our detailed reports include measurement data, uncertainty analysis, and recommendations for calibration intervals. We also maintain comprehensive records for easy certificate retrieval and audit support.

Flexible Service Options

We understand that every business has unique operational requirements. That's why when possible we offer on-site calibration services to reduce your downtime. For instruments requiring controlled environments or specialized equipment, our fully equipped laboratories provide optimal calibration conditions.

Fast Turnaround Times

Production schedules don't wait for calibration delays. We prioritize quick turnaround times without compromising quality, helping you maintain operational efficiency while meeting calibration requirements. Our streamlined processes and scheduling ensure your instruments return to service as quickly as possible.

Audit-Ready Calibration in 3 Simple Steps

1

Submit Your Equipment List

Send us a list of the equipment you need calibrated, and we’ll provide a tailored quote with clear pricing—no hidden fees.

2

Schedule Your Calibration

Choose a convenient time for an in-lab or on-site equipment calibration. Our certified technicians ensure precision and compliance with ISO/IEC 17025 standards.

3

Stay Compliant & Audit-Ready

Receive detailed calibration reports and certification, giving you peace of mind for audits and operational excellence.