Laboratory instruments can connect to LIMS, but connectivity alone does not prove control.
During a project, Zamann Pharma Support supported a German pharmaceutical company in strengthening CSV compliance with EMA and FDA expectations.
We found that LIMS instrument interfaces were implemented but not validated. Balances and chromatographs transferred data, but completeness and accuracy were never verified.
In addition, some raw data bypassed LabWare entirely.
These weaknesses reduced control over electronic laboratory data and increased the risk of data manipulation. The source also identified this issue as a major FDA 483 risk, especially in QC laboratories.
Our team assessed the interfaces, identified the main compliance gaps, and defined a focused action plan.
Regulatory References: FDA 21 CFR 211.68 and EU GMP Annex 11 require appropriate controls to protect computerized systems and data integrity. ISPE GAMP 5 supports risk-based validation, while USP <1058> reinforces analytical instrument qualification
Our team supports the planning, execution, and maintenance of qualification and validation activities, including IQ, OQ, and PQ, to keep GMP-regulated systems compliant and under control.
Each instrument interface should be validated, and transfer integrity should be verified. The validation should confirm that transferred data remains complete and accurate. In this case, balances and chromatographs transferred data, but completeness and accuracy had never been verified.
Manual corrections create a compliance risk when users can change transferred data without adequate traceability. In this case, manual corrections lacked sufficient control. Therefore, the assessment identified them as a significant electronic data integrity concern.
The laboratory should map all interfaces and data flows, including alternative workflows. It should also validate transfer integrity and document fallback procedures. In this case, some raw data bypassed LabWare entirely, which reduced control over electronic laboratory data.
