Compliance is always a primary concern for Life Science and Pharmaceutical companies as they develop life saving products for the public. The consultants at Paradigm are very experienced with regulatory guidelines and can assist your organization in achieving and maintaining regulatory compliance for your ECM system.
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Ensure 21 CFR 11, 210, 211 and 820 compliance
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Develop Standard Operating Procedures
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Prepare the Validation Plan, validation protocols (IQ, OQ, PQ) and traceability matrix
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Prepare protocols and test scripts
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In the Biopharmaceutical industry the Clinical Research Associates have, what can be, the daunting task of tracking and maintaining essential documents for clinical trials. These documents have a significant importance and it is vital to the Clinical Development Department have the confidence to submit these documents to Document Control and know that they will be readily retrievable. At Paradigm Consulting we understand this issue and can develop a filing taxonomy for the Clinical Operations Department site files and master files documents that will facilitate speedy retrieval of essential documents, greatly decrease the amount of time the CRA's spend on tracking documents and result in increased confidence in Document Control Department 's document management abilities.
We have also developed a training curriculum designed to familiarize your Document Control staff with the phases of a clinical trial and the essential documents generated during the trail process so decrease the occurrence of mis-filed documents. Our training covers ICH guidelines and the relevant portions of the Code of Federal Regulations. To view a sample of the training curriculum click here.
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