Many pharma firms use software to make or store GMP data. For example, LIMS, QMS, eBMR, or ERP. Once software supports GMP, you must prove it fits its purpose. You must also control risks. You must keep it under control for its whole life. This work is called Computer System Validation, or CSV. T…

Your Compliance Extends Beyond Your Walls A pharmaceutical manufacturer’s regulatory responsibility does not end at the boundary of its own facility. Under Good Manufacturing Practice regulations across all major jurisdictions, the organisation that holds the manufacturing authorisation …

The Technology Gap in GMP Audit Programmes Pharmaceutical quality assurance has always been a documentation-intensive discipline, but the tools with which that documentation is managed have evolved unevenly across the industry. In manufacturing and laboratory operations, technology adoption ha…

What Audit Findings Tell You About Your Organisation Audit findings are more than a compliance report card. They are a diagnostic signal, revealing where an organisation’s quality management system is under stress, where process discipline is inconsistent, and where regulatory risk is ac…

The Compliance Challenge Is Not Proportional to Size Regulatory expectations for Good Manufacturing Practice do not scale with the size of a pharmaceutical company. A small manufacturer or contract development organisation operating under MHRA, FDA, or EMA oversight faces essentially the same …