Paper logbooks are still everywhere on GMP manufacturing floors. They do the job, but they cost more than most sites realise.
In the medical device industry, internal audits are often viewed primarily as a regulatory requirement. ISO 13485:2016 requires organisations to assess the effectiveness of their Quality Management System (QMS). However, organisations that treat internal auditing purely as a compliance exercise risk missing a significant opportunity.
Why the Path to AI Runs Through Connected Manufacturing
The future of quality management is no longer about forcing processes into rigid systems; it is about empowering organisations to design quality around their unique needs. That’s exactly where MasterControl’s Advanced Quality Event Management (AQEM) comes in.
Paper manufacturing records usually fail in the same predictable ways: missed fields, illegible handwriting, manual calculations, messy corrections, missing signatures, and not enough context when something goes wrong. The results are also predictable: more deviations, slower batch release, and uncomfortable audit discussions because the evidence...
The Great Convergence of Quality, Manufacturing, and Intelligence
For medical device quality leaders, 2026 is the year the baseline for excellence is redrawn. The long-discussed digital transformation of quality is no longer a future concept but the new operational reality, codified in regulation. The go-live of the U.S. Food and Drug Administration’s (FDA) QMSR is the primary catalyst, yet it arrives alongside...
INFOGRAPHIC: A snapshot of how SeerPharma supported its customers with Quality and GMP Best-Practices in 2025 by providing QA & GMP Consulting, Auditing & Training services as well as MasterControl solutions "Qx" electronic Quality Management Systems (eQMS) & "Mx" Manufacturing Execution Systems (MES) with electronic Batch Records (eBR).
Electronic signatures - once an unfamiliar or unused feature - have now become an essential capability within computerised systems supporting GxP operations across the regulated life-science industry. Today, solutions like Adobe Sign and DocuSign are widely used to route documents and records for review and approvals both within organisations and...
