Validation Services
Validation provides documented evidence that a system, instrument, process, or environment performs as intended and produces consistent results within specified parameters. Where calibration verifies that an instrument reads accurately, validation verifies that the system, as a whole, is suitable for its intended use and meets the requirements of your protocol.
We provide on-site validation services for FDA-regulated facilities across North Carolina, South Carolina, and Virginia, with experience in the documentation standards expected during FDA inspection and audit.
Services
Temperature Mapping
Thermal distribution studies for warehouses, controlled storage areas, cold rooms, incubators, stability chambers, and other temperature-controlled environments. Studies are conducted following your protocol or a protocol we develop to your specifications, using calibrated data loggers placed per a defined mapping strategy. Results include temperature distribution data, identification of hot and cold spots, pass or fail determination against your acceptance criteria, and a final report formatted for regulatory submission.
Applicable to USP, GDP, FDA guidance on temperature-controlled storage, and site-specific quality requirements.
Small Chamber Mapping
Temperature and humidity mapping for environmental chambers, stability chambers, and incubators. Studies are conducted with your chamber at operational conditions, using calibrated sensors at defined positions per protocol. Results document uniformity of conditions throughout the chamber volume and identify any zones outside acceptance criteria.
Autoclave Validation
Thermal distribution and heat penetration studies for steam sterilization equipment. Studies are conducted using calibrated temperature sensors placed per protocol at defined positions including the coldest location determination. Results document that sterilization conditions are achieved and maintained throughout the load and the chamber.
Includes support for IQ, OQ, and PQ phases per your validation master plan requirements.
Equipment Qualification
Installation Qualification (IQ): documented verification that equipment is installed per manufacturer specifications, applicable regulatory requirements, and your site standards.
Operational Qualification (OQ): documented verification that equipment operates as intended throughout its defined operating range.
Performance Qualification (PQ): documented verification that equipment consistently performs as intended under conditions representative of actual use.
We have experience with qualification of laboratory equipment, process equipment, and facility systems in FDA-regulated environments.
Documentation
All validation work is executed against a written protocol approved before execution begins. Deviations from protocol are documented in real time. Final reports include raw data, calibration certificates for all reference instruments used, deviation documentation, and a conclusion statement against the acceptance criteria defined in the protocol.
Documentation is formatted to meet 21 CFR Part 11 electronic records requirements where applicable and is suitable for direct inclusion in your validation master plan records.
Regulatory Background
FDA expects that equipment and systems used in the manufacture, processing, packing, or holding of drug products, biologics, and medical devices be qualified and validated per 21 CFR Parts 210, 211, and 820 as applicable. Temperature-controlled storage areas are subject to USP and GDP guidance on storage condition verification. Our validation services are designed to produce documentation that meets these expectations and supports your facility's ongoing regulatory compliance.
Contact
Validation scope varies significantly by facility, equipment type, and protocol requirements. Contact us to discuss your specific needs and we will develop a service proposal tailored to your program.