Industry Expert Pick
Indian pharmaceutical companies face stringent regulatory requirements — Schedule M, CDSCO compliance, 21 CFR Part 11 for data integrity, and export market requirements. IT systems must be validated, audit trails must be maintained, and data integrity standards are non-negotiable. Here's the essential IT stack.
21 CFR Part 11 is the US FDA regulation governing electronic records and electronic signatures in pharmaceutical manufacturing. Indian pharma companies exporting to the USA must ensure their ERP, LIMS, and QMS systems meet Part 11 requirements: audit trails, access controls, system validation, and electronic signatures. SAP Business One with validated configurations meets Part 11 requirements.
Yes. Pharma companies conducting clinical trials, pharmacovigilance, or post-market surveillance collect patient data that is sensitive personal data under the DPDP Act. Consent management, data security, and breach notification requirements apply. IT systems handling patient data must have appropriate access controls and encryption.
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