In early 1999, SeqWright began the development and implementation of its Quality Assurance Program in order to better support its growing base of pharma and biotech clients. By the middle of 2000, SeqWright had successfully passed its first GLP-level audit. Currently, we host and pass numerous audits every month, and we hold "approved" and "preferred" vendor status with some of the most prominent pharmaceutical and diagnostic product development companies today.
Our Quality Systems are built up around guidelines described in section 21 of the Federal Code. These include regulations governing non-clinical laboratory practice, electronic signatures, and drug manufacturing. In addition, SeqWright is CLIA certified for the receiving and testing of patient samples. Our facility is open to all auditors (with a formal NDA/CDA in place), and we do accept and consider all advice regarding improvements and additions to our pre-existing systems.
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21 CFR 58 compliant (GLP) |
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21 CFR 11 compliant (Electronic Signatures) |
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Partial implementation of 21 CFR 210/211 (cGMP) such as OOS investigations |
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CLIA certified |
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Validated systems and processes |
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Geospiza Finch® Suite sample tracking |
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SQA-registered Quality Assurance Units (QAUs) |
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