Independent, Audit-Ready, From Within The Industry
 
 
Asset Management &
On-Site Calibration for
Pharma, Biopharma,
and Medical Device

Patient Care Driven, Customer Focused

 
 
Veteran Disabled-Certified
ISO 17025
On-site techs at
100+ Sites.
Never failed an
FDA/FDB/EU/Asian
audit
 

Core Capabilities

Programs engineered around ISO 17025 and cGMP

 
Flagship

Asset Management

Lifecycle strategy, criticality, SOPs, metrology hierarchies, audit trails and KPI dashboards

  • RCM based asset programs
  • Change control

On-Site Technicians

Embedded calibration maintenance teams with high retention and low discipline

  • 100+ placements to date
  • Lower turnover faster ramp
  • PPE ready

Calibration, Validation & More

CMMS, metrology labs, passivation, water testing, TEB III repair

  • Calibration & IPT programs
  • ISO 17025 accredited lab
  • cGMP SOP
 

Mission

A California based Calibration/ Metrology company specializing in servicing the Biopharmaceutical and Medical Device industries with FDA cGMP compliance, product efficacy, lot repeatability, safety of patients, utilities and manufacturing equipment repeatability, and safety of personnel.

ISO/IEC 17025:2017 & ANSI/NCSL Z540-1-1994 SO Certificate

CLICK HERE FOR  ISO/IEC 17025:2017 & ANSI/NCSL Z540-1-1994 SO Certificate

Equipment Calibration, Asset Management Systems, and Validation

Calibration, Repair, Preventive Maintenance, Qualifications, Validations, IQ/OQ/PQ

Equipment Calibration Services

Whether responding to emergency situations, performing routine maintenance, or installing new equipment, customers rely on the expertise and experience of GL Technologies LLC.

Our team performs FDA cGMP-compliant calibration and maintenance services trusted by industry leaders in the medical device, biopharmaceutical, and life science sectors, as well as local municipalities and military installations.

We specialize in the calibration and troubleshooting of clean utilities, automated process equipment, analytical laboratory instruments, HVAC controls, SCADA systems, Building Management Systems, and passivation services.

GL Technologies Calibration Services

GL Technologies is a full-service calibration provider specializing in the biopharmaceutical and medical device industries.

Our management team has worked in, managed, and developed fully FDA cGMP-compliant programs.

We provide roving calibration crews for scheduled programs, shutdowns, and new system installations. In addition, we place qualified professionals at both large and small biopharmaceutical and medical device facilities.

Our services include:

  • Calibration and metrology support
  • Asset and CMMS management
  • Compliant program development
  • SOP creation and documentation
  • Maintenance and facilities support

GL Technologies can design and implement fully compliant programs, including method development, equipment identification, tolerance assignment, calibration cycle determination, and SOP design.

Our management has developed programs audited by regulatory authorities in the United States, Europe, and Asia. We also specialize in on-site personnel placement and candidate evaluation. To date, we have placed more than 180 professionals in California and international facilities, with no penalties for full-time hiring by our clients.

Equipment Calibration Articles

Frequently Asked Questions

What is commissioning in the pharmaceutical industry?

Commissioning is the documented process of ensuring that facilities, utilities, systems, and equipment are designed, installed, tested, and capable of operating according to predetermined specifications. In pharma, commissioning verifies that all systems meet GMP (Good Manufacturing Practice) requirements before validation and routine operations.

How is commissioning different from qualification or validation?

Commissioning focuses on installation and functional testing to confirm systems meet design and operational requirements. Qualification (IQ/OQ/PQ) is a subset of validation that provides documented evidence systems consistently perform as intended. Validation ensures processes produce consistent, compliant results. Commissioning typically precedes and supports qualification/validation.

Why is commissioning important for pharmaceutical facilities?

Because pharmaceutical environments must comply with strict regulatory standards (FDA, EMA, MHRA, etc.), commissioning ensures systems are properly installed, safe, reliable, and ready for validation. It reduces risk of compliance failures, costly rework, and delays in bringing products to market.

Which systems and equipment require commissioning?

Commissioning is required for any new or modified system or piece of equipment that must be proven safe, functional, and compliant before entering routine use. This typically includes mechanical systems such as HVAC, boilers, and water treatment units; electrical systems like power distribution and emergency backup generators; control systems such as SCADA, PLCs, or building automation; and process equipment including pumps, compressors, laboratory instruments, and pharmaceutical manufacturing machinery. In regulated industries, commissioning also extends to cleanrooms, sterilizers, and critical utilities such as Water for Injection and compressed air.

What are the typical stages of the commissioning process?

The typical stages of the commissioning process begin with planning and design review, followed by pre-commissioning inspections and installation checks. Functional testing is then performed to verify system operation, followed by performance verification under real operating conditions. The process concludes with documentation, operator training, and formal handover into operational use.

How long does commissioning usually take?

Commissioning timelines vary depending on system complexity and scope. Simple installations may take a few days, while complex pharmaceutical or industrial systems may take several weeks due to extensive testing, calibration, and regulatory requirements.

Who performs commissioning in pharma projects?

Commissioning is typically handled by specialized engineers and technicians experienced in GMP facilities. Independent third-party providers are often engaged to deliver objective testing, documentation, and subject matter expertise.

What documentation is produced during commissioning?

Commissioning documentation typically includes plans and protocols, installation and functional test records, calibration certificates, safety and performance test results, punch lists, and final commissioning reports. These documents provide compliance evidence, audit traceability, and support ongoing operations.

How does commissioning reduce risk in pharmaceutical operations?

Commissioning reduces risk by ensuring systems and equipment are tested and verified before full-scale production. It identifies design flaws, installation errors, and performance gaps early, minimizing downtime, compliance failures, and product quality risks while protecting patient safety.

What regulations or guidelines govern commissioning in pharma?

Commissioning is governed by ISPE Baseline Guides, Good Engineering Practice (GEP), FDA cGMP regulations, EU GMP guidelines, and ICH Q8–Q10. These frameworks support a lifecycle approach to quality, compliance, and patient safety.

Powered By

GL-Tec Capabilities Include:

Hood Certification (Fume & Bio Safety Cabinets
Analytical Services
 (HPLC PM OQ Repair, Mass Spectronomy, Sartorious)
sPRT Calibration (Standard Resistance Thermometer)
Building Maintenance Systems
CMMS Software
Fume Hood Certification

Join the GL Technologies Team!

For some of us, GL Technologies is the best first job they can have. For others, this is their career-long home. And there are many more in between. Whatever your career goals, if you work with integrity and committment there’s a place for you!

IQ OQ PQ Services

GL Technologies provides IQ, OQ, and PQ services for biopharmaceutical and pharmaceutical organizations throughout California.

A strong commitment to IQ/OQ/PQ qualification is critical for regulatory compliance and operational reliability. Installation Qualification (IQ) verifies proper equipment installation and documentation, ensuring a solid foundation for operation.

Operational Qualification (OQ) confirms that equipment operates within defined specifications under varying conditions. Performance Qualification (PQ) validates consistent performance during real-world use while meeting regulatory requirements.

Mass Spectrometry Calibrations

Biopharmaceutical and pharmaceutical companies across California rely on GL Technologies for mass spectrometry calibration services.

Mass spectrometry calibration ensures the accuracy and precision of mass spectrometers used to identify and quantify chemical compounds. Calibration aligns measured mass-to-charge (m/z) values with known reference standards.

This process improves data reliability and enables the detection of subtle molecular differences, making proper calibration essential for regulated life-science applications.

HPLC Calibration

GL Technologies is a trusted provider of HPLC calibration services throughout California. We support pharmaceutical, biotechnology, medical, and research organizations with precise and reliable calibration solutions.

Our technicians use advanced tools and validated methods to verify instrument accuracy, improve performance, and extend equipment lifespan while maintaining compliance with regulatory standards.

Each calibration program is tailored to the specific needs of the client, ensuring consistent and dependable analytical results.

HPLC Repair

GL Technologies provides expert HPLC repair services to ensure reliable and uninterrupted laboratory operations.

Our experienced technicians diagnose issues, replace components, and restore system performance with minimal downtime. We handle both routine repairs and complex system overhauls.

Clients trust our team for fast, cost-effective, and dependable HPLC repair solutions that keep critical analytical systems operating at peak performance.

GL Technologies Location