#29 Medical device software - key insights to meet regulatory requirements
Overcome data integration challenges with ALCOA+
data integrity - the basics ALCOA and ALCOA+ contain common principles for managing data integrity and good documentation practices for the pharmaceutical and medical device industry. ALCOA, a term and framework originally introduced by the FDA in the 1990s. The EMA later developed this into ALCOA+ mainly with regard to clinical trial data. The plus sign in ALCOA+ adds additional principles for data integrity
Case: World-class QC lab after major upgrade
Validation and quality assurance for compliance In 2017, a major pharmaceutical company faced the daunting challenge of upgrading its QC laboratory. With over 100 different instruments and equipment to replace, and new data integrity and compliance requirements, careful planning and expertise were required. Many of the existing equipment/instruments had reached the end of their life cycle and met the [...]
Effective validation management
The right skills are crucial to the outcome The role of a validation manager is to ensure that a piece of equipment, system or process complies with the relevant standards, rules and specifications and is fit for purpose. The validation manager leads the validation and qualification work by planning for and designing strategies that underpin the [...]
Next steps towards the future of medicine
In the biotech sector, interest in advanced therapies is growing and a growing biotech company is taking the lead in developing Pharma for Advanced Therapy Medicinal Products (ATMP). Their focus is on unique and personalized cell therapies targeting cancer, a pioneering approach in medical research. Like other medical products, quality requirements are high and to ensure product stability, reproducibility and above all
Artificial Intelligence in Life Science
A historical overview and a look ahead The use of AI in life sciences is nothing new. Machine learning and deep learning algorithms have long been used in research and development as well as in industrial applications. But with the rapid growth of generative AI, the AI landscape has changed dramatically, which also means that the regulatory framework must be adapted. […]
Supplier evaluation in Life Sciences
Evaluation or assessment of suppliers is a crucial process, but requirements vary across industries. What is standard in ISO or GLP may not be what you need for GMP/GDP or GCP. How do you navigate through this complex landscape of requirements and expectations? And how do you ensure that your organization's corporate mission does not rest on
Maximize the potential of your business
Is your company ready to step into the future of quality management? Electronic quality management systems (eQMS) offer a revolutionary way to structure, integrate and automate quality processes, such as document management, training, deviation and change management. But how do you best navigate the transition to an eQMS and what do the different steps look like? In this article, we explore the way [...]
Optimize safety & efficiency
New medical devices are delivered and installed daily in hospitals and healthcare providers across Sweden. When it comes to larger and building-affecting equipment, such as magnetic resonance imaging (MRI), computerized tomography (CT), operating room equipment and integration systems, an independent inspection of the delivery may be relevant, or even part of the requirements for the installation, to ensure a correct and [...]...
Meeting data integration challenges with ALCOA+
Data integrity is essential for any pharmaceutical company launching a product. Regulations dictate what must be done to assure integrity, but achieving it is often complex. In part two of our series, we look a little closer at some key challenges and how they can be overcome using ALCOA and ALCOA+. Data integrity - the [...].
The central role of medical software in life sciences
Medical device software has become a catalyst for progress in the life sciences, transforming how data is collected, analyzed and used to shape decisions and strategies. By integrating advanced algorithms, machine learning and artificial intelligence (AI), software has taken research to new heights and provided tools that bridge the gap between theory and practice. It [...]
#13 GAMP 5 to support quality assurance of computerized systems in Life Science
Challenges with data integrity - ALCOA
data integrity is crucial for any pharmaceutical company launching a product. Regulations dictate what must be done to ensure integrity, but achieving it is often complex. In the first part of our series, we take a closer look at some key challenges and how they can be overcome. In the second part, we will review the ALCOA+ [...].
Successful conversion of premises into a high-tech NMR lab
A fast-growing pharmaceutical company was faced with the challenge of transforming its existing sub-standard premises into a state-of-the-art NRM analysis lab. The project was to be carried out in the midst of a burning Covid-19, with all the additional obstacles the pandemic brought. The complexity of building a high-tech lab of this kind required a comprehensive understanding of the industry, the regulations and, not [...]...
Meeting data integration challenges in new product development - ALCOA
Data integrity is essential for any pharmaceutical company launching a product. Regulations dictate what must be done to assure integrity, but achieving it is often complex. In part one of our series, we look a little closer at some key challenges and how they can be overcome through the ALCOA lens. In part two we [...]
Webinar part 2: Cybersecurity - How are life science companies affected by NIS2 & what applies?
Webinar: Cybersecurity and new requirements for life science companies - NIS2 in focus
The new NIS2 Directive: strengthened cybersecurity & increased obligations
NIS2-direktivet: Europas nyaste sköld mot digitala hot För företag inom Life Science-sektorn kan uppdateringen av direktivet ha betydande konsekvenser och påverkan. Ökade cybersäkerhetskrav, skydd av forskningsdata och krav på incidentrapportering för att nämna några områden. Detta för att säkra vår digitala framtid och stärka vårt cyberförsvar. NIS2-direktivet har förstärkt kraven på medlemsländerna att etablera nationella […]
GAMP 5 Second Edition - future-oriented interactive e-learning for life sciences
Att dela med sig av kunskap och att utbilda andra är något som vi på Plantvision brinner för. För oss handlar det om att inspirera, utveckla och diskutera för att nå nya insikter, samtidigt som vi vill lyfta högaktuella ämnen. Ett sådant ämne är otvivelaktigt GAMP 5 och, inte minst, den nya versionen GAMP 5 […]
Increased cybersecurity requirements in the EU - companies need to act now
Cybersecurity is a hot topic right now. Several new directives and regulations will come into force in the coming years, but many companies are completely unaware of the upcoming tightening of EU legislation. This is despite the fact that it will improve data protection, prevent fraud and protect communication networks. In the European Union (EU), companies will soon be [...]...