Des nouvelles défaillances de "Data Integrity"...
Pour cette société allemande :
4. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data.
Our investigator found that your (b)(4) system used for (b)(4) and (b)(4) testing lacked access controls and audit trail capabilities. For example, all employees had administrator privileges and shared one user name, so actions could not be attributed or traced to specific individuals. This exposed your electronic data to manipulation and/or deletion without traceability.
Our investigator also noted that your firm copied raw data to a CD (b)(4), and then deleted the data from the (b)(4) system to free space on the hard drive. Files copied to the CD were selected manually; the selection process was not supervised. Without audit trail capabilities or supervised file selection, there was no assurance that all raw data files were copied to the CD before they were permanently deleted from the system.
Pour cette société chinoise :
2. Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.
During the inspection, an FDA investigator discovered a lack of basic laboratory controls to prevent changes to your firm’s electronically stored data and paper records. Your firm relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed with established specifications and standards.
Our investigator found that your firm routinely re-tested samples without justification, and deleted analytical data. We observed systemic data manipulation across your facility, including actions taken by multiple analysts and on multiple pieces of testing equipment.
Specifically, your Quality Control (QC) analysts used administrator privileges and passwords to manipulate your high performance liquid chromatography (HPLC) computer clock to alter the recorded chronology of laboratory testing events.
3. Failure to record activities at the time they are performed, and destruction of raw data.
Your employees did not complete batch production and control records immediately after activities were performed. Your operators used “mock” sheets (copies of the uncontrolled copy of the master production records) to capture critical manufacturing data. Your employees then completed and backdated batch production records days after operations ended.
Our investigator noted discrepancies between the “mock” sheets and the complete batch production record that your firm represented as the official record for that lot. Because of your uncontrolled documentation practices, you could not produce evidence that your batch production records were accurate.
Batch production records must be generated contemporaneously and include complete and accurate information on the production and control of each batch. The practice of using unbound, uncontrolled loose paper, in conjunction with backdating records, raises additional concerns about the integrity, authenticity, and reliability of all your data, and the quality of your API.
Plus d'information ici et là.
