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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FROM THE BLOG
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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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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…
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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…
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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 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…
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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Meet Dimitrij Gvozdev
Meet Dimitrij Gvozdev We would like you to meet Dimitrij Gvozdev, who is passionate about working with KVALITO and the impact he makes in his role as Operations Manager, responsible for talent acquisition and management as well as key account management. What’s your professional background, and how did you become an Operations Manager? I completed my degree in Fitness economics (BA) in a dual study program before I started my journey with KVALITO. Fitness economics is a combination of medicine, fitness and business management. My study program combined academic studies with practical experience, which I liked a lot. After successfully…
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…