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, Uncategorized
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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SMART quality & compliance
CDRH Validation vs. CSV
“A goal without a method is nonsense.” — W. Edwards Deming What is CDRH Validation? In the USA, the FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States. THE CDRH also defines a validation approach for process and software for medical devices and radio-emitting products. There are 3 classifications of medical devices: Class I General Controls (with or without exceptions) Class II General Controls and Special Controls (with or without exceptions) Class III General Controls and Premarket Approval This classification implies a risk…
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SMART quality & compliance
How to Overcome Validation Costs
“It is thrifty to prepare today for the wants of tomorrow.”–Aesop, Greek author (620 BC – 560 BC) Validation costs are normally high and would be subject to more time and resources than a project without such requirements. However, there have always been ways to reduce the impact of these costs. Below are at least three typical causes for having overly raised costs for validation of a system, together with hints on what to do to bring the costs down. Also listed, is a more future-oriented approach to selecting pre-configured standard systems that have all interfacing systems ready-made, all cloud-based, and fail-safe. But let’s start with the classical fails and costly overdoing: 1. Starting…
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SMART quality & compliance
Medical Devices; US and Chinese legislation
US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA Legislation. Adapted from FDA Legislation. Copyright 2020, Kvalito Consulting Group. How to classify a device under US regulation? How to classify a device under US regulation? In the USA, there are 1700 generic groups of devices classified within 16 medical specialties (21 CFR 862-892). The classification is based on a risk approach. Medical devices classified as Class I are considered as having the lower risk, Class II is considered a moderate risk and class III is the higher risk. How are the…
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SMART quality & compliance
Risk Management for Medical Devices: ISO 14971:2019
What types of risks are covered by Risk management? It covers the harms related to patients, users or/and environment. What is the difference between Design controls and Risk management? Design Controls prove that the Medical Device is safe, effective and meets the indications for use, and help reduce product risks. In parallel, Risk Management intends to identify, evaluate, analyze, assess and mitigate potential product issues. Indeed, there is a correlation between these two notions, however, the perspectives are different. What are the steps of the Risk Management process? A risk Management file must include: Risk management Plan Risk Analysis…
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