Many laboratories have yet to make the leap from paper to electronic records such as LIMS. There are usually valid reasons for holding back and maintaining the paper-based system of the dark ages. These reasons tend to be things like “we don’t have the budget”, “we don’t have time to implement a system”, “our lab isn’t big enough to use a system like that” or “why fix what isn’t broken”. While these are all suitable reasons for maintaining a paper-based system,
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Assessing your LIMS supplier is a necessary process for laboratories operating in a regulated industry, but it is also considered, in general, good practice. The supplier assessment should be scaled appropriate to the risk, complexity of your LIMS, and the services provided. The assessment is most useful
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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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Operating a laboratory within regulatory requirements can be a challenge. The wording of regulations is typically cryptic, and there’s always room for different interpretations. Audit trails are an important factor for compliance because
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GxP compliance in the pharmaceutical industry is a hot topic. With increasing numbers of drugs coming onto the worldwide market, it is important for pharmaceutical companies to make sure they operate within industry guidelines from development to production. Many companies use a Laboratory Information Management System - or LIMS - to facilitate compliance and ensure they have everything in place during regulatory body audits.
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