Remedying the paper trail: Manufacturing a digital route to compliance

As regulatory enforcement surges, life science manufacturers must shift away from paper-based systems to ensure compliance. As regulatory enforcement surges, life science manufacturers must shift away from paper-based systems. Transitioning to an integrated digital framework builds compliance directly into the daily shop floor workflow. Image credit: Shutterstock Regulatory investigators’ remit extends beyond routine standard operating procedure (SOP) reviews; they watch how operators work, how equipment is qualified, and whether batch records tell a complete, accurate story. Consequently, the manufacturing floor presents the highest compliance risk as it is where data integrity is most vulnerable. Operators who manually bridge paper records…

Source: Clinical Trials Arena