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.
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.
Cyber reports to Indian boards still lead with blocked attacks and patch percentages. For a manufacturer the measure that matters is how long it would take to make and ship medicine again from a clean start, and most companies have never timed it.
Validation of plant and laboratory software in Indian pharmaceutical companies is still judged by the thickness of its documents. A risk-based approach spends less effort on paper and more on testing whatever could harm a patient or corrupt a record.