Access Databases


  1. Warning Letter: Failure to Provide Staff with Database Access (ucm303979)

    “Acorda Drug Safety staff should have SOPs, work instructions, database access, and training sufficient to ensure adequate surveillance, receipt, evaluation, follow-up, and reporting of adverse event information for all of the firm’s products.”

    View the original warning letter.


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  2. Warning Letter: No audit trail, data cannot be verified (s6736c)

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    All study data are handled and controlled by your Study Coordinator, who enters the data into an electronic data base. There is no audit trail or log of data changes that are made to the information in the database. Data cannot be verified against source records, since such records are not maintained.”

    View the original warning letter.


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  3. Warning Letter: Nonconformance with 21 CFR Part 11 (m4105n)

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    • In addition, we further request details regarding steps your firm is taking to bring your electronic CGMP records into conformance with the requirements of 21 CFR Part 11; Electronic Records; Electronic Signatures.
    • This inspection disclosed deficient controls in the laboratory electronic record keeping system, which is used for maintaining chromatography and audit trails.

    View the original warning letter.


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  4. Warning Letter: Lack of security in database (m3450n)

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    Failure to maintain the integrity and adequacy of the laboratory’s computer systems used by the Quality Control Unit in the analysis and processing of test data. For example a) There was a lack of a secure system to prevent unauthorized entry in restricted data systems. Data edit authorization rights were available to all unauthorized user not only the system administrator.

    View the original warning letter .


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