KVALITO holistic consulting service approach includes Audit and Assessment Services. Maturity, Risk and Security Assessments, Mock Inspections, and Routine Audits for Global Clients Worldwide.
Audit and assessment are exceedingly complex practices, which ensure a vigorous financial stability and the trustworthiness of the company. Kvalito with its extensive auditing services provide comfort and security to management and support the business in achieving its strategic objectives.
Kvalito offers: Business Operational Audits, Regular Health Check Audits, IT Maturity, Risk and Security Assessments, Mock Inspections, IT audit processes, History of IT and Information Security Auditing, Quality, Cost and Technical Audits, Management audits as well as Routine Audits for Global Clients Worldwide.
Challenges
- Global companies have to comply both with Global and local regulations. This requires effort and in being audit ready. Questions asked are:
- How much readiness is required and to what level?
- Where should the focus be, documentation, legacy items, operations,…?
- Validation /Qualification efforts are too much or too little and not risk based. Documentation is not available especially when it equipment is concerned and their maintenance information.
Opportunities and Solutions
- Biologics, sterile, cell therapy-based manufacturing sites
- Development centers
- Quality systems
- Contract manufacturers and suppliers
- Manufacturing sites
- Non-manufacturing sites
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SMART quality & compliance
Usability and Labelling
What is usability ? The new Regulation, MDR, strengthens the rules regarding labelling and usability. Usability is the characteristic of the user interface that facilitates use and establishes effectiveness, efficiency and user satisfaction in the intended use environment. In parallel, usability engineering is defined as Human Factors Engineering. It is applying knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability. Usability have an impact on safety and performance of MD. Indeed with the right usability, some medical errors, injuries can be avoid. MDR : “Reduce, as far as possible, the risks related to the…
SMART quality & compliance
Precision Medicine
Precision Medicine Precision medicine, also known as personalized medicine, is an approach to developing safer novel therapeutics that integrate genomics and big data (genetic, clinical, molecular, diagnostic and environmental data) to detect pathogenic events at the genome level. Biologics, vaccines and highly selective NCEs are matched with disease targets validated by human genetics, to tailor medicines to patients. A human has 99.9% genetic similarity to the next human, 96% genetic similarity to a chimpanzee, 90% genetic similarity to a cat, and 60% genetic similarity to a chicken, and a banana. Fruit fly protein sequences have mammalian homologs while almost 75%…
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…
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…
SMART news
Quality as a Driver in Organizations
KVALITO is a diverse company. Being a woman-owned business, we acknowledge equality and diversity in all our working practices. We support our entire team to achieve success within their projects and their career development. After all, without excellent consultants, KVALITO would not exist! We are continually looking towards the future to ensure that we support our clients in the most effective, innovative ways. We believe in staying on top of the latest developments and practices in the Life Science industry. KVALITO has embedded quality principles in its strategy since its founding. We believe that quality, being part of the whole…
SMART Career
Effective Communication
“Less is more”—Robert Browning “Andrea del Sarto” (1855) Communication truly is the engine of fruitful relationships. We often don’t think about the process of communicating while we are doing it, but paying closer attention to how you send and receive information can help you prevent misunderstandings, bolster your relationships and save time. We communicate to explain, inspire, ask, understand, and motivate. But do businesses sometimes fall short of effective communication? When teaching my toddler how to communicate, my primary goal is to break it down and to slow it down. Observing my child shows me how important tone, pace, eye…
SMART Career
How can we deal with conflict at work?
“Don’t fear conflict; embrace it – it’s part of your job.” —Clara Sayrol When a group of people comes together, conflict can arise and may become integrated into any part of a social and organizational setting. This is no different at work. The most common instigators of business conflicts have two root causes: poor communication and the inability to control one’s emotions. Conflict can start with a simple disagreement and often escalate into an argument that impedes the productivity of a team and decreases employee morale. Therefore, it is important to be able to recognize conflicts early on and address…
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…
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…
SMART quality & compliance
What are the principal differences between the conformity assessment process of a medical device in the USA and in the European Union?
Figure 1: Comparison of European and US Conformity Assessment process of Medical Devices. Adapted from European law and United States law. Copyright 2020, Kvalito Consulting Group. The difference in the conformity assessment process between the European Union and the USA, is the need of a notified body in the European Union. The notified body is an organization designed by a member state to assess the conformity of products against the current European regulations and directives. The legal manufacturer of the medical device must contact a Notified Body (not necessarily from his own country) in order to obtain the CE mark…
SMART Corporate Citizenship and Social Responsibility
KVALITO Consulting Group supports National Cancer Society Malaysia (NCSM)
This year KVALITO made donations to two carefully selected charities/organizations, to offer help where it is most needed. Selvi Nadajaran, Director KVALITO APAC, met Chong Wei, Marketing Director of the National Cancer Society Malaysia to present KVALITO’s donation signalling KVALITO’s firm commitment to improving the health and lives of patients. Established in 1966, NCSM is the oldest NGO in Malaysia and is accredited by the Ministry of Health. By providing far-reaching education and awareness programmes, screening and care, research, psychological counselling and advocacy, the NCSM directly supported 400,000 Malaysians in 2019. Free housing is provided to cancer patients (and their families) receiving…
SMART Corporate Citizenship and Social Responsibility
KVALITO Consulting Group helps ZI to make an impact with music therapy
KVALITO is happy that we could offer help with a donation, so children and youths can get involved in music therapy. Thank you Zentralinstitut für Seelische Gesundheit for your inspiring work. Read the whole story here
SMART quality & compliance
Electrical safety and EMC 60601
IEC 60601: Safety and effectiveness of medical electrical equipment. This standard specifies general requirements for basic safety and essential performance. Collateral standards apply the 60601-1-3 standard states for radiation protection in diagnostic X-ray equipment. The other standards are related to the specific characteristic of all medical electrical equipment not fully addressed in the standard 60601-1, as standard 60601-1-2 states for EMC and 60601-1-8 for Alarms. An electrical medical device needs to comply with the IEC 60601-1. Every point of the standard needs to be verified and referenced in a Compliance or Conformity Matrix. Tests must be conducted on the device…
SMART news
KVALITO Malaysia Sdn Bhd is founded
KUALA LUMPUR, Malaysia October 29th 2020. KVALITO Consulting Group today, announced the opening of a new office in Malaysia which will help the company to accelerate growth in the APAC region. KVALITO Consulting Group is a strategic service partner and global life science network for regulated industries. ”For several years now, KVALITO has been ramping up its international service offering. With an increasing number of opportunities presented to us in Asia, especially in Malaysia, China, Japan, Korea, and Southeast Asia, we are enthusiastic about establishing this new office and growing new partnerships in the region.” Selvi Nadarajan, Director, KVALITO APAC. This expansion consolidates the group’s international reach and signals KVALITO’s firm commitment to partnering with its clients in accordance…
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…
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…