The last check before test results reach a client is the approval stage. Where test results are formally reported on a certificate of analysis, approval is authenticated by signature. So, what does that signature mean? And what should Lab Managers review before they sign the dotted line?
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Laboratory management can be challenging, especially when you try to keep your ducks in a row. With the implementation of a LIMS system, processes can be refined not only to create uniformity in your laboratory but
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It’s a question I ask daily; how are you currently managing your QC data?
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Audit trails are a common LIMS feature required for regulated laboratories, but they are generally a useful tool for any laboratory – regulated or not. For those of you who are new to LIMS,
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When you’re working in a fast-paced environment such as a laboratory, you might not have the time to implement improved ways of working. You may be using an existing LIMS, and are used to the workarounds and quirks of the system.
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Many laboratories introduce LIMS to help with sample data management and reporting. Some labs will have used the same system for 12 years without upgrades, and other labs will
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The purpose of quality is to ensure standards are maintained so that products, services and processes are effective and fit for purpose. Laboratories must maintain high quality standards to provide confidence in
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Validating LIMS is a fundamental requirement for GMP compliance. Where LIMS is used to store and process GMP data, it is imperative that
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The Medicines and Healthcare products Regulatory Agency (MHRA) has a responsibility to protect public health by ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy. Each year, they conduct
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