With our validation services, Labcal Solutions support customers in meeting industry requirements and guidelines set by government agencies, industry guidelines and industry regulatory bodies.
Based on your requirement and projects maturity, we will assist you at various validation levels including consultation, document writing (protocol, worksheet and report compilation), and execution of the final report.
Our validation team is highly experienced in the pharmaceutical industry, our understanding of all the critical aspects of your process will allow us to assist you with the entire or partial validation process with:
Labcal Solutions can assist you with on-site or remote validation and qualification services of a wide range for laboratory life science equipment, cold chain, temperature-controlled vehicle / trucks, sterilization equipment, production and process equipment, logistics and storage areas, container studies and route assessment, as well for computerized control or monitoring systems.
With the collaboration of our metrology team, Labcal Solutions can support its customers across the full validation process, including calibration of the critical instrument and thermal study process.
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Risk assessment
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User Requirements Specification (URS)
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Functional Specification (FS)
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Design Specification (DS)
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Design Qualification (DQ)
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Installation Qualification (IQ)
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Operational Qualification (OQ)
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Performance Qualification (PQ)
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Etc