Karolinska
The Galderna
Permobil
Xbrane
Elekta
The Swedish eHealth Agency
AstraZeneca
Validation and qualification
During the training, you will gain insight into the basic tools and knowledge for effective validation and qualification through a risk-based approach for both process equipment and computerized systems in Life Science. Through a combination of theory and practical exercises, we explore how you can apply a risk-based approach to both prevent and manage potential nonconformities [...]
Quality assurance & QMS
Våra tjänster inom Kvalitetssäkring Kvalitetslednings- system Att skapa ett kvalitetssystem som uppfyller regelverk och standarder är relativt lätt. Att däremot lyckas ta fram ett kvalitetssystem som både är compliant och anpassat utifrån er verksamhet, som blir ett stöd istället för ett hinder, det är allt annat än trivialt. Med rätt kompetens och stöd blir både […]
Validation
Our services in Validation Validation of computerized systems Validating that systems are reliable and comply with regulations and guidelines (such as GAMP) is crucial to meet both regulatory requirements and business needs. We have deep and long-standing expertise in computerized systems validation (CSV), and have been offering training in the field for many years. Validation [...]
Requirements management
Våra tjänster inom Kravhantering Krav- specifikation Rätt krav i kravspecifikationen är grunden för ett framgångsrikt projekt. Vi hjälper dig att samla in, formulera och strukturera krav så att de går att testa, spåra och leva upp till. Samtidigt som vi har koll på underliggande regelverk. Leverantörs-bedömningar Det är viktigt att välja rätt leverantör utifrån krav […]
GMP
During the training, you will gain insight into the basics of what GMP is and why it exists. Which authorities, requirements and regulations you must comply with. What a quality system is and its components. The importance of good documentation, deviation and change management. Risk and deviation management to understand how you can avoid deviations from GMP regulations. CONTENTS Basic principles [...]
QA IT
In the pharmaceutical industry, where accuracy and reliability are essential, computerized systems play a crucial role throughout the chain from research and development to clinical trials and production. These systems control critical processes in, for example, manufacturing, laboratory analysis and distribution, making their proper functioning essential for the safety and efficiency of the entire production and distribution chain. Quality assurance of computerized [...].
System management
Effective systems management is crucial in regulated industries such as pharmaceuticals, where careful control and oversight of computerized systems is required. These systems, which are critical for everything from research and development to manufacturing and distribution of Pharma, must be managed to ensure consistent performance and compliance with strict regulatory standards. A robust system management helps to [...].
GMP
All pharmaceutical manufacturers intending to market or manufacture their products in the EU must comply with good manufacturing practice (GMP), regardless of where in the world they are based. GMP defines the minimum standards that a pharmaceutical manufacturer must meet in its production processes. By following GMP, manufacturers can systematically prevent contamination, errors and inconsistencies, which is crucial for patient safety. Compliance [...]
Combination products
Combination products are becoming increasingly common in both the pharmaceutical and medical device sectors, reflecting a trend towards more integrated treatment solutions. These innovative products, which combine Pharma with medical device components, must navigate a particularly complex regulatory environment. The standard for pharmaceutical manufacturing, Good Manufacturing Practice (GMP), offers a foundation, but it does not fully cover the unique requirements of
Validation & qualification
Validation and qualification are a fundamental part of the pharmaceutical industry and other sectors of the life sciences industry. These processes ensure that equipment, method, process, premises and systems meet specified requirements and perform reliably for their intended use, meaning that they consistently deliver the expected product and function. Accuracy in these processes is essential [...].
data integrity
In regulated activities such as the pharmaceutical industry, data integrity is fundamental to ensuring that all computerized systems handle data correctly and reliably. This means maintaining and protecting data throughout its lifecycle - from collection to archiving - to guarantee that the information is complete, accurate and accessible to authorized parties. Complying with GxP regulations does not require [...]
GAMP 5
Computerized systems are an important part of the Life Science industry and play a critical role from research and development to clinical trials, manufacturing and distribution. Systems used in GxP-regulated environments must be reliable and carefully customized to meet the specific needs and requirements. Good Automated Manufacturing Practice (GAMP) is a well-established