In highly regulated industries, precision, compliance, and documented control are not optional—they are the foundation of operational integrity. At International Process Solutions, we provide GMP-compliant calibration and regulatory maintenance services designed to meet the strict demands of regulated environments while supporting operational excellence. Our services are engineered to ensure that every instrument, system, and measurement process performs with verified accuracy, traceability, and full regulatory alignment.
We serve organizations that cannot afford uncertainty. Through disciplined processes, experienced technicians, and audit-ready documentation, we deliver calibration and maintenance programs that stand up to the most rigorous regulatory scrutiny while minimizing downtime and operational risk.
Comprehensive GMP Calibration Services Built for Regulated Environments
We deliver end-to-end GMP calibration services for critical measurement and control instruments used across regulated operations. Our programs are structured to align with FDA, ISO, USP, EU GMP, and industry-specific regulatory expectations, ensuring that calibration activities support both compliance and performance.
Our calibration services cover a broad range of equipment, including:
- Temperature and humidity sensors
- Pressure gauges and transmitters
- Balances and scales
- Pipettes and liquid handling devices
- Torque tools
- Flow meters
- Electrical and dimensional instruments
- Process control instrumentation
Each calibration is executed using NIST-traceable reference standards, following approved procedures with defined acceptance criteria. Instruments are evaluated for accuracy, repeatability, and tolerance compliance, ensuring results that can be confidently defended during inspections and audits.
Regulatory Maintenance Programs That Protect Compliance
Calibration alone is not enough. Regulatory agencies expect organizations to maintain control over equipment throughout its lifecycle. Our GMP regulatory maintenance services are designed to support continuous compliance by addressing preventive maintenance, corrective actions, and equipment reliability.
We establish customized maintenance programs that include:
- Scheduled preventive maintenance activities
- Functional verification and performance checks
- Adjustment and repair coordination
- Deviation documentation and resolution support
- Change control alignment
- Equipment history tracking
By proactively maintaining critical instruments and systems, we help prevent drift, failures, and unplanned downtime that can compromise product quality or regulatory standing.
Audit-Ready Documentation and Data Integrity
Documentation is the backbone of GMP compliance. We deliver clear, complete, and inspection-ready calibration and maintenance records that meet regulatory expectations for accuracy, traceability, and data integrity.
Our documentation packages include:
- Detailed calibration certificates
- As-found and as-left data
- Measurement uncertainty where applicable
- Reference standard traceability
- Pass/fail determination against defined tolerances
- Electronic and hardcopy record options
All records are generated under controlled processes to support ALCOA+ principles, ensuring data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
Industry-Specific GMP Calibration Expertise
We support a wide range of regulated industries, each with unique compliance pressures and operational challenges. Our experience allows us to adapt GMP calibration and maintenance programs to industry-specific expectations without compromising consistency or control.
Pharmaceutical and Biopharmaceutical Manufacturing
In pharmaceutical environments, instrument accuracy directly impacts product safety, efficacy, and regulatory approval. We support manufacturing, quality control, and laboratory operations with GMP calibration programs that integrate seamlessly into validated systems and quality management frameworks.
Medical Device Manufacturing
Medical device manufacturers rely on precise measurements to ensure product performance and patient safety. Our services support compliance with FDA and ISO 13485 expectations while maintaining production efficiency.
Life Sciences and Biotechnology
From R&D to commercial production, life science organizations require flexible yet compliant calibration solutions. We provide scalable programs that support innovation while maintaining strict GMP controls.
Laboratories and Research Facilities
Accuracy and repeatability are essential in analytical and research environments. We deliver calibration services that support method validity, data confidence, and regulatory acceptance.
On-Site and In-Lab Calibration Flexibility
Operational continuity matters. We offer both on-site calibration services and controlled laboratory calibration, allowing organizations to choose the most efficient approach based on equipment criticality and operational constraints.
- On-site calibration minimizes downtime and keeps equipment in place
- In-lab calibration provides controlled conditions for high-precision instruments
Our technicians arrive fully equipped, trained, and prepared to work within GMP-controlled environments while respecting site-specific safety and quality protocols.
Experienced GMP-Trained Calibration Professionals
Our team consists of highly trained calibration and maintenance professionals with direct experience in regulated facilities. Every technician understands GMP expectations, documentation requirements, and the importance of procedural discipline.
We emphasize:
- Consistent execution of approved procedures
- Strict adherence to safety and quality standards
- Clear communication with quality and operations teams
- Professional conduct during audits and inspections
This expertise ensures that our services integrate smoothly into existing quality systems without disruption or compliance risk.
Risk Reduction Through Preventive Maintenance and Control
Equipment failures and measurement drift create risk. Our regulatory maintenance approach focuses on risk reduction and process stability, helping organizations maintain control over critical parameters.
By identifying trends, addressing early signs of degradation, and maintaining accurate records, we support:
- Reduced deviations and investigations
- Improved equipment reliability
- Longer instrument lifespan
- Predictable maintenance scheduling
This proactive strategy supports both compliance and cost control.
Scalable Programs for Single Sites or Multi-Facility Operations
Whether supporting a single facility or multiple sites, we provide scalable GMP calibration and maintenance programs designed for consistency across locations. Standardized procedures, centralized documentation, and coordinated scheduling ensure uniform compliance while accommodating site-specific needs.
Our scalable approach supports organizational growth, facility expansion, and operational complexity without sacrificing regulatory control.
Support During Audits and Regulatory Inspections
Audits are a reality in regulated industries. Our services are designed to withstand inspection scrutiny. We provide documentation that is clear, complete, and defensible, and we support clients during audits by ensuring calibration and maintenance records are readily available and well-organized.
Our clients benefit from confidence during inspections, knowing their calibration and maintenance programs are built on solid GMP foundations.
Why Organizations Trust International Process Solutions
Organizations choose International Process Solutions because we deliver more than calibration—we deliver regulatory confidence. Our focus on accuracy, documentation, and compliance allows our clients to concentrate on their core operations while we manage the complexity of GMP calibration and maintenance.
We combine technical expertise with regulatory awareness, operational efficiency, and a commitment to quality that supports long-term compliance and performance.
Partnering for Long-Term GMP Compliance
GMP calibration and regulatory maintenance are ongoing responsibilities, not one-time activities. We partner with organizations to provide consistent, reliable, and compliant services that evolve with regulatory expectations and operational needs.
Through structured programs, experienced professionals, and disciplined execution, International Process Solutions delivers calibration and maintenance services that protect product quality, regulatory standing, and operational success.
