When Brexit happened in the UK on 31 January 2020, the regulatory picture changed with it. The MHRA (Medicines and Healthcare Regulatory Agency) was previously created to regulate UK medicines, medical devices, and blood products. However, amended EU regulations remain in…
How InstantGMP Software Manufacturing System solves both EU Annex 11 and FDA 21 CFR Part 11 Regulated products are a (intra) world business. The revenue for the entire Pharma Domain alone is almost US $1.5trillion. Given this potential market scope, related services, and…
How InstantGMP PRO Workflows Expedite Qualified Person Activities for the European Union Regulations One key requirement of the European Union regulatory guidelines is that Electronic Batch Records be certified by a Qualified Person. The Qualified Person also has other responsibilities…
Why Controlling Documents in Electronic Batch Records Matters The quality of production operations in regulated industries can vary directly with the quality of the information in the Electronic Batch Record. Both the work completion and “review and release” activities demand…
A typical Electronic Batch Record can contain valuable information. One consistently shared truth in business is that there might be key relationships that are currently unknown, yet to be found and appreciated. One needs to use an effective discovery tool…
It’s useful to understand the trends of FDA citations. Satisfying the CFR’s remain a challenge; the awareness, experience and tools used for compliance are (and should be) evolving. Reviewing the deficiencies as a checklist can prove a first step toward…
We at InstantGMP have valued customer support since our inception in 2004. Three premises have remained true: The Code of Federal Regulations (“CFR”) is enforced The quality of customer user experience varies directly with the quality of support One purchases…
Are you looking for a comprehensive and effective solution for managing your electronic batch records, quality, document, and inventory management systems? Look no further than InstantGMP™ PRO. After conducting extensive market research and evaluating several options, we have found that…
Master Production Records A requirement common to FDA-regulated industries is a master production record (MPR). They are also known as master batch records or master manufacturing records. Master production record is the critical design details for the derived batch records…
Just what is this 21 CFR Part 11? 21 CFR (Code of Federal Regulations) Part 11 established electronic records and signatures for FDA regulated industries. While standardizing guidelines, the code importantly improves documentation and operational efficiency in use. 21 CFR…