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Validated software the night-shift chemist can rely on
Indian API manufacturers are digitising batch records by putting their paper forms on tablets. That removes the paper but keeps every weakness of the paper record, and it spends validation effort on the part of the record that mattered least.
Every few weeks I meet a technology leader from another Indian API company who has just finished converting batch records to electronic form. The project usually has the same shape. The paper batch manufacturing record, page by page, is reproduced on a tablet. Operators tap where they used to sign, and fields that took handwriting now take typing. Quality reviewers read the record on a screen instead of at a desk stacked with folders. The plant announces that it is paperless, and customer auditors, for a while, are pleased.
