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I received two warning letters recently. Company A and Company Bwas accused of “failing to implement appropriate controls over computers or related systems to ensure that only authorized personnel can make changes to master production and control records or other records.” Although the records were maintained in electronic form, they could be altered or deleted without appropriate controls.
It is standard practice for laboratories to allow only appropriate users to access and change records and to maintain a complete audit trail of these changes. Ensuring the integrity of electronic test data is a key point in FDA audits, and to maintain compliance, laboratories should ensure:
- Data is collected electronically LIMS for Laboratory Instrumentswithout human intervention,
- All relevant raw data and metadata are recorded, in addition to any data derived from it.
- Each LIMS user has his or her own username and password, and there are no shared accounts.
- Users can access only the data they need to perform their duties.
- Key checkpoints such as data verification and approval enforce the use of passwords and, where appropriate, electronic signatures.
- If data records are overwritten, a record of who made the change and why must be maintained for audit purposes.
These rules apply not only to the laboratory’s LIMS, but also to other laboratory information systems, such as a chromatography data system (CDS) that may be integrated with the LIMS. The goal is to establish a defensible audit trail that demonstrates clear control over the data chain throughout its lifecycle (from data acquisition to reporting), ensuring the integrity of the data.
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