Laboratory Development & Validation : Life Science Solutions
If I prove reproducibility does that mean it's accurate? What about false positives or negatives? Method validation is one of the measures universally recognized as a necessary part of a comprehensive system of quality assurance in analytical chemistry. But so is the development of methods that indicate accuracy, precision, selectivity, sensitivity, reproducibility, and stability.
Validation involves documenting, through the use of specific laboratory investigations, that the performance characteristics of the method are suitable and reliable for the intended analytical applications. The acceptability of analytical data corresponds directly to the criteria used to validate the method. At Raland Technologies we have developed literally hundreds of methods for use in industry in compliance with guidelines set for by USP, IUPAC, ISO, and AOAC. We are here to help you every step of the way.
Services
- Annual Lot Analysis
- Equipment Specification and Selection
- Equipment Installation and Validation (IQ, OQ, PQ)
- Laboratory Information Management Systems (LIMS)
- Laboratory Design, Installation and Qualification
- Method Development (On-site)
- Method Validation (On-site)
- Remediation of Regulatory Issues (FDA 483)
- Stability Program Development
- Standard Operating Procedure Authoring
- Technology Transfer
- Training
- Vendor Auditing
Areas of Expertise
- Bioanalytical Testing (LC/GC/GCMS/LCMS, etc.)
- Chemical Testing (LC/GC/GCMS/LCMS, etc.)
- Microbial Testing (Bioburden, Gel Clot, etc.)
- Physical Testing (Friability, hardness, etc.)