EffiChem Meets Your Data Integrity Needs

“Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.” MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 (UK).

“The use of Excel requires many management controls to prevent data alteration, and Excel does not have an audit trail to identify data changes.”
FDA Letter to PM Resources Inc. Dec 18 2015

“The investigator noticed that the use of the Excel® spreadsheets in analytical calculations are neither controlled nor protected from modifications or deletion.”
FDA WL: 320-13-22

Data integrity ensures that the accuracy, completeness, content, and meaning of data is retained throughout its entire lifecycle. Current guidance from the MHRA (UK) and from the FDA (US) demands that regulated labs implement digital data integrity frameworks. The use of Excel-like spreadsheets – which do not have data integrity features, is a frequent target of regulators and source of warning letters.

EffiChem takes data integrity seriously, and we have chosen to hard-code this functionality into the system. When you enter, capture, process, report or store raw data, the full audit trail is always produced. The same is true for every change you make, because EffiChem preserves all changes to the data while retaining original material. This audit trail information includes not only the data, and changes themselves, but also all required metadata. EffiChem has no delete function, and the user cannot amend or switch off the audit trail function, which means that data integrity is ensured. It’s just one more way in which EffiChem gives you confidence in quality.

Switching to EffiChem saves time, money, and stress.

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