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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.
How was method validation achieved for entering pharmaceutical markets?
Subject – Entering the pharmaceutical market Our client is a prominent vodka producer and a
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
How eCValidation delivered efficient Computerized System Validation (CSV) results
The client sought to validate two modules within a new system, P4Labs, developed to meet specific company requirements (GAMP 5 category). The modules included:
How we assisted our client in re-validating their clinical testing management system
The client’s objective was to re-validate their clinical testing management system, comprising multiple modules. Following an audit deviation and the outcome of the periodic review, the client aimed to attain a verified state of the system, aligning with legal requirements and best practices.
How we assisted our global customer with thermal mapping in a factory in Switzerland
Our primary task was to assist the client in meeting deadlines for qualifying approximately 40 devices. The objective was SIP* Cycle Development (CD). The plan was to provide documented evidence that the SIP process could fulfill the defined acceptance criteria,
How GMP implementation made our client stand out in the market
The client aimed to achieve the best GMP standard for spirits production in Europe. Their goal was to differentiate themselves from competitors based on quality assurance, ensuring that customers would choose their products even in the face of slight price differences.
How did we drive compliance improvement for our global Norwegian client?
Operating within the European market, our client must adhere to EU regulations while also preparing for inspections from international bodies such as the United States Food and Drug Administration (FDA). Their validation processes lacked comprehensive documentation.
Implementation of GMP requirements in industries outside the pharmaceutical sector
The implementation and maintenance of the GMP system is a highly challenging, time-consuming, often tedious,
Factory and Site Acceptance Tests
The primary objective of this article is to provide an overview of the comprehensive topic of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). It begins by defining the core differences between the tests, moves on to the stages of test planning, defines the participants in FAT tests, etc.
Validation of Computerized Systems in a Pharmaceutical Wholesaler
Pharmaceutical wholesalers rely more and more on advanced IT systems for the storage, management and distribution of medicinal products. The introduction of information technology in the pharmaceutical industry has brought many benefits, but at the same time imposes responsibility for ensuring the security, effectiveness and compliance with regulations of these systems.
Process Validation in a Pharmaceutical Wholesaler
Pharmaceutical supply chains are inextricably linked to Good Distribution Practices, Good Manufacturing Practices, and the Code of Federal Regulation; these regulations and guidelines ensure that pharmaceutical products are distributed according to appropriate standards and with safety. One of the key elements of ensuring safety and quality in pharmaceutical wholesalers is process validation.
Revised Annex 1, EudraLex Volume 4
Annex 1, “Manufacture of sterile medicinal products,” is part of EudraLex Volume 4, which provides guidance on the minimum control measures required to protect sterile medicinal products during manufacture. All manufacturers supplying medicinal products to the European market must comply with these requirements to minimize the risk of microbiological, particulate and pyrogenic contamination of the final product.
The legal approach to the use of medicinal marijuana in the pharmaceutical industry in Poland.
Medicinal marijuana is a controversial topic. People without awareness often perceive medicinal marijuana as a dangerous, addictive drug used illegally.
How to do business under MDR? A 12-step guide to preparing your company for the new regulations
The requirements brought in by the Medical Device Regulation have posed a serious challenge for many companies operating in the medical device industry. Adapting to the new legal reality requires a significant amount of time and effort. We have prepared a short guide for the transition process based on the EU recommendations to give you a clearer view of the situation.
Data integrity – order and security
Modern IT solutions and industry automation are changing the world, and in many areas are contributing to the dynamic development of various sectors, including the pharmaceutical industry.
How to mitigate risk in validating a cloud solution?
Companies are eager to implement cloud solutions, so they can cut costs and streamline their business efficiency.
Quality outsourcing – is it possible?
The use of quality assurance outsourcing solutions seems to be revolutionary to some, but is there really anything to be afraid of?
IT Project Management: A Validation Challenge
Computer system validation is a procedure performed in every pharmaceutical or medical device company that uses IT systems at the stage of production, logistics or distribution of its products.
The first stage of implementing a new manufacturing area — good and bad practices
This article presents observations on the performance of work related to the commissioning of a new area at the initial stage of investment.
Are you ready for the MDR? This is how new EU regulations may impact medical device producers
Medtech companies are facing major compliance challenges.
Who, when and how should prepare for the amendment of Annex 1?
The pharmaceutical industry is characterised by numerous requirements governing its functioning.
Computer System Validation – SaaS solutions
One of the increasingly popular forms of cloud computing are so-called SaaS services, or Software as a Service.
From CSV to CSA – what should you know about the new validation paradigm?
Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA).
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Computer System Validation – SaaS solutions
One of the increasingly popular forms of cloud computing are so-called SaaS services, or Software as a Service.
From CSV to CSA – what should you know about the new validation paradigm?
Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA).
