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Milestones Reached: DSHEA and InstantGMP Anniversaries in 2024

The Dietary Supplements Health and Education Act (DSHEA) was enacted on October 25, 1994. Thirty…

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Electronic Batch Record Strategies for Gene Therapy Products

Electronic Batch Record Strategies for Gene Therapy Products Two things drive progress in this new, vital,…

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Blogs

Why Gene Therapy Companies need a Quality & Electronic Batch Record System

Gene therapy is on the move. The industry is currently valued at $5.61 Billion, with…

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Blogs

MHRA GMP, EU GMP, and how InstantGMP Software Ensures Compliance to Both

When Brexit happened in the UK on 31 January 2020, the regulatory picture changed with…

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Blogs

How InstantGMP Software Manufacturing System solves both EU Annex 11 and FDA 21 CFR Part 11

How InstantGMP Software Manufacturing System solves both EU Annex 11 and FDA 21 CFR Part 11 Regulated…

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Expediting the EU Qualified Person

How InstantGMP PRO Workflows Expedite Qualified Person Activities for the European Union Regulations One key…

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Why Controlling Documents in Electronic Batch Records Matters

Why Controlling Documents in Electronic Batch Records Matters The quality of production operations in regulated…

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Productive Manufacturing Insights using GXQuery

A typical Electronic Batch Record can contain valuable information. One consistently shared truth in business…

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Top 10 FDA Citations

Top 10 FDA Citations…and How to Avoid Them

It’s useful to understand the trends of FDA citations. Satisfying the CFRs remains a challenge;…

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