SMART quality & compliance
New Medical Device Regulations (MDR) demand Quality Management Systems (QMS) for Software as a Medical Device (SaMD)
“Innovation is the calling card of the future.” Anna Eshoo It is remarkable, alone in the iOS App Stores, there are tens of thousands of apps which are registered as Software as a Medical Device (SaMD). With the new Medical Device Regulations (MDR) becoming effective in 2020, the companies that have developed these apps will need to perform considerable upfront review and update activities because of changes to classification, and as a consequence of this, most will need to set up a Quality Management System (QMS) to support the lifecycle of their products. The major challenge for these innovative, often…
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SMART quality & compliance
GDPR- Changes in Data Privacy Protection Affects Multinational Businesses
This week, effective May 25th, 2018 the General Data Protection Regulation (GDPR) will be valid in the European Union (EU). This regulation harmonizes data privacy laws across Europe and replaces the current data protection directive 95/46 EC. The GDPR is a complex piece of legislation comprising 11 chapters, 99 articles and 173 recitals. The aim of the GDPR is the protection of the data privacy of each individual (data subject). In short, the protection against abusive data processing, the protection of the right to informational self-determination, the protection of personal rights in data processing, as well as privacy protection must be ensured to be compliant with GDPR. The following article…
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SMART quality & compliance
Data Integrity- where GxP, IT-Security and Data Privacy come together
Data Integrity (DI), a vital part in the Compliance Framework of Life Science Companies, is mostly associated with GxP, but, it also applies to Information/IT-Security and Data Privacy. Take patient data of clinical studies, for example. Data Integrity in general Data Integrity is the maintenance and assurance of the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data Integrity in the GxP-Environment Data Integrity presents a major challenge to biotechnology and pharmaceutical companies as information needs to…
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SMART quality & compliance
Data Integrity: Risks and Solutions
To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity. Data Integrity means the overall documentation of every GxP-relevant activity performed during the whole product life cycle. The FDA recommends that this documentation should be based on the ALCOA principles. To guarantee Attributable, Legible, Contemporaneous, Original and Accurate documentation, life-science companies increasingly seek experts for advice. Focusing on data integrity by kicking off respective projects and hiring consulting experts within this field…
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SMART quality & compliance
Brexit and its impact on Pharma Compliance
The definite impact of Brexit on the Pharma Industry is, for the moment, vague. What is clear though, is that Brexit will have a big impact on the pharma supply chain and pharma compliance bodies. Due to Brexit the EMA must move to a new location, which is Amsterdam. All pharma compliance bodies which need to sit in an EU-country need to also move e.g.: QP, QPPV, Regulatory Affairs, etc. One advantage is, that after Brexit, the MHRA is only allowed to do inspections for medicines sold on the UK market like the FDA. It will be a long process…
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SMART quality & compliance
How to validate an autonomous self-patching system?
In 2016, the Defense Advanced Research Projects Agency (DARPA) of the United States Department of Defense organized the Cyber Grand Challenge. At this event, fully, autonomous systems with no human interaction attacked each other, but also developed patches for their own vulnerabilities. This event was carried out under lab conditions (simple operating system with few system calls, no file storage, exploiting and patching only via an interface to a central adjudicator system). It gave an outlook into the future of Information Technology as a whole, mostly in IT-Security and Validation. In future, we will see cyber-attacks run completely by Artificial…
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SMART quality & compliance
Patient Information Leaflets – how to overcome CSV challenges for mobile and web apps?
Taken from: http://rollingplanet.net/wp-content/uploads/2015/03/beipackzettel.jpg Many pharmaceutical companies provide electronic versions of their patient information leaflets (PIL) to their patients by presenting them in the form of a PDF on their own websites, adding them to a mobile application or providing them to pharmacies or agencies, which in turn would host the PIL on their websites. This service is of great benefit to patients who loose the paper version provided in the drug packaging and for those who prefer to access the information online at the time they most need it. As the majority of people now own smart phones, it only seems…
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SMART quality & compliance
Block Chain Technology and the Pharmaceutical Industry – A good fit?
“Undoubtedly, it’s best applications are yet to come.” Alex & Don Tapscott on the Blockchain technology in “Blockchain Revolution” Picture Source: https://media.licdn.com/mpr/mpr/AAEAAQAAAAAAAAyNAAAAJGYyOTRjN2Q4LTA3ZjctNGU2Ny04NWYyLWRjNDA2YzljNjdlNw.jpg, 21.06.2017, 15:42 Uhr Blockchain – what it is and why it is the technology of the future? Blockchain is the technology of the future: With its decentralized database structure, providing the user with yet unprecedented data security and integrity standards by maintaining data records which are tampering-resistant, the blockchain methodology has already conquered the finance sector with the invention of bitcoin. But this technology is much more than its first implementation as part of the cryptocurrency bitcoin would suggest: it is…
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SMART quality & compliance
Same but different – implementation of a track-and-trace serialization of pharmaceuticals in the US
End-to-end vs. Track-and-trace verification The ever-growing threats of illegal (falsified or substandard) pharmaceuticals entering the legal supply chain require specifications of systems effectuating measures to improve patient safety. These are defined by national and / or supranational legislative institutions. The falsified medicines directive by the EU (2011/62/EU, including the Commission Delegated Regulation (EU) 2016/161) requires the implementation of an end-to-end serialization of pharmaceuticals to prevent falsified medicines from entering the legal supply chain (click here to read more on the EU directive). In the US, the Drug Quality and Security Act (DQSA) was signed into law in November 2013. As part of this…
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SMART quality & compliance
Better Prepared with a Health Check ?
CC BY-SA 3.0 NY “By failing to prepare, you are preparing to fail”. – Benjamin Franklin FDA published an announcement in August 2016 to focus on part 11 inspections in near future. The future is now. Project tollgates, health checks, periodic reviews, assessments, audits, real time monitoring. What is the best way to always be prepared and ready for Health Authority inspections? Computerized systems and projects vary in size and complexity ranging from few users by supporting a simple business process to thousands of users supporting multiple business processes. Furthermore, projects can range from single location to a global rollout…
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