Why MES is a key component of Pharma 4.0
In the era of Industry 4.0, companies must adapt their production processes to meet growing market and regulatory requirements.
How to prepare for a GMP audit?
Effective preparation for the audit and its professional execution not only help meet legal requirements but also serve as a valuable tool for early problem detection, process optimization, and improvement of the quality management system.
How outsourcing helped a tobacco manufacturer meet compliance needs
The first project we supported was preparing the client for an FDA audit, as they aimed to enter the U.S. market with Reduced Risk Products.
Webinar: Paperless Validation with Veeva Vault Validation Management
Discover how to reduce lead times by 50% through paperless validation, guided by experts from eConsulting and Veeva Systems. We’re excited to be part of the upcoming webinar discussing the ROI of adopting paperless validation. If you’re interested in learning how Veeva Vault Validation Management has helped customers significantly reduce lead times and want to …
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What is the Annual Product Quality Review (APQR)?
Working in the pharmaceutical industry, we are obliged to perform the Annual Product Quality Review, although it may be called variously: Annual Product Review – APR (FDA) or Product Quality Review – PQR (EU, ICH7), the idea of such a review is one: it is an organized,
Qualification of clean steam installation for a leading Polish biotech company
The client’s goal was to qualify their clean steam installation and verify that it meets the requirements defined in the URS and risk analysis, ensuring it provides clean steam with the desired specifications.
Comprehensive equipment qualification for a Polish diagnostic manufacturer
The client’s objective was to qualify laboratory equipment (biochemical analyzers) used for testing intermediates and final products in accordance with applicable regulatory requirements.
Health Revolution Congress
We’re at the Health Revolution Congress today, organized by Barcelona Health Hub. As the largest summit in Europe focused on Digital Health, it brings together an impressive mix of global startups, top pharmaceutical companies, innovative investors, and key healthcare institutions to explore and address the pressing issues in modern healthcare. This event provides us with …
How was method validation achieved for entering pharmaceutical markets?
Subject – Entering the pharmaceutical market Our client is a prominent vodka producer and a leader in this economical segment, headquartered in Poland. With over 30 years of experience, they specialize in producing ethanol and bioethanol for the chemical, food, and pharmaceutical markets. The client’s objective was to enter the pharmaceutical market, requiring the attainment …
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How to efficiently amend an important SOP to accommodate the interests of all stakeholders, meet requirements, stay sane, and not throw the baby out with the bathwater
Why bother amending SOPs (Standard Operating Procedure) at all when things have been fine so far? We worked so hard two years ago during the last amendment, and we already have so much other work, so why stir things up now? On the one hand, it’s just three things that need changing, maybe five sentences …