SMART quality & compliance
How is a system validated?
Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and vocabulary. A Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. Validation: Confirmation, through the provision of objective evidence, that the specified requirements for a specific intended use or application have been fulfilled. Qualification: Process to demonstrate the ability to fulfill specified requirements In general : Validation: For systems or general topics: process, systems, etc. Qualification: For single or individual items within your system, process: Equipment, lab methods, etc Below is a simplified process diagram on how to validate a system…
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SMART quality & compliance
How to conduct a Software Risk Assessment
First, the risk must be identified. It is always the same scheme; a hazard combined with a hazardous situation can lead to harm. All factors must be determined before the hazard occurs. Risks combine the severity of harm (S) and the probability of occurrence(O). A numerical score is assigned to assess the risk. Risk = probability of damage x severity of damage. A simple evaluation scale needs to be used and it must be equivalent for all products. See the table below as an example: Then the score is interpreted by this table: Then risk control measures must be defined…
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SMART quality & compliance
What is a Software Product Framework?
A software product framework is a set of software units assembled in a software item. The collective software items form the software system. The software system, together with the packaging and the instruction for use, shape the software product. The International Electrotechnical Commission (IEC) is an international standards organization that prepares and publishes international standards and technical specifications for all electronic, electrical, and associated technologies – collectively known as “electrotechnology”. See: IEC 62304:2006. This regulation, [1] in section 4.3, defines software safety classes, based on severity (not probability) of risk: – Class A: No injury or damage to health is possible – Class…
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SMART quality & compliance
What is Software of an Unknown Provenance known as SOUP?
International standard IEC 62304 defines life cycle requirements for the development of medical software inside medical devices. This regulation is harmonized by the European Union and the United States and thereby serves as a standard by which to respect the regulations of both markets. A SOUP is a “software item that is already developed and generally available, and that has not been developed for the purpose of being incorporated into the medical device (also known as “off-the-shelf software”) or a software item previously developed for which adequate records of the development process are not available.” (Source: IEC 62304). The FDA defines SOUP as some…
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SMART quality & compliance
Good Documentation Practices in Regulated Environments
“Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you did a poor job no matter what you really did.” —Marco Polisena Introduction Good Documentation Practices (GDP) has evolved to be one of the essential Good Practices in regulated environments such as pharmaceuticals manufacturing for many years now. Having developed from predicate rules for record-keeping in quality system management, as well as 21CFR 11 for electronic records and electronic signatures, GDP has evolved to become a quintessential tool for documents industry. “In any regulated industry, documentation can provide…
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SMART quality & compliance
Digitalization of Pathology – A New Approach
Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and improve the workflow in pathology laboratories. It focused on data management based on information generated from digitized specimen slides by using virtual microscopy. This virtual microscopy uses digital scanners to capture digital slides, store them, analyze them and finally, share it with the scientist. These scanners mimic the conventional microscope with additional software that visualizes and analyzes the captured images. The practice of digital pathology, also called Whole-Slide Imaging (WSI) saves time on tasks, such as inspecting glass slides and analyzing tissue samples directly…
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SMART quality & compliance
Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) – Old Wine in a New Bottle?
“Discovering the unexpected is more important than confirming the known.” —George Box, Stuart Hunter, and William G. Hunter Introduction The World Health Organisation (WHO) specifies that “the purpose of validation is to confirm that the computerized system specifications conform to the user’s needs and intended use by examination and provision of documented and objective evidence that the particular requirements can be fulfilled consistently.” Validation should establish confidence in the accuracy, reliability and consistency in the performance of the system and it should also ensure that all necessary technical and procedural controls are implemented confirming compliance with good documentation practices for…
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SMART quality & compliance
What is the development lifecycle of a Medical Device?
What is the development lifecycle of a Medical Device? First and foremost, the user requirements need to be defined by the organization. Based on the fact that the design and development of the Medical Device can be planned, inputs are implemented and tested, which lead to outputs. The design and development process is then verified, and if needed, some inputs can be added (related to the outputs). The whole process is validated; the CE marking must be accepted before transferring the design and development to production and commercialization. The entire lifecycle is continually controlled. Risk management must be included in…
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SMART quality & compliance
LIMS Implementation: Success Factors from a Project Manager Perspective
“Change before you have to.” —Jack Welch A Laboratory Information Management System (LIMS) is software that allows your laboratory to manage samples and associated data effectively. Its primary purpose is to improve lab efficiency and accuracy by reducing manual operations, automating workflows and also managing sample associated information. Most pharma companies whose laboratories perform medical analysis or other testing services require compliant systems that ensure that sample testing can be performed to an acceptable standard which ensures that all data is reliable and accurately reported. After having chosen the appropriate LIMS vendor to your organization, the most common practice to…
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SMART quality & compliance
Sterilization Processes for Medical Devices
What kind of sterilization methods can be used for a medical device? There are different methods for the sterilization of medical devices, using gas and steam or radiation. Radiation methods: The principle of this form of sterilization treatment is to bombard the sample with high energy electrons or high energy electromagnetic radiation. This activity leads to the formation of unstable free radicals, molecular ions, and secondary electrons. These products react with molecules and fracture their chemical bonds. DNA and RNA are sensitives to this sterilization approach. The advantage of this technique is that products can be sterilized through radiation after packaging due to the penetrating power of the incident gamma-ray. Nevertheless, some drugs like heparin cannot be irradiated because there is a risk of changing…
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