ACCORDING TO YOUR NEEDS, BEYOND YOUR EXPECTATION
Do all your company’s processes and systems comply with current industry best practices, your company standards and regulations?
Are you planning to conduct important projects and therefore are in need of experienced people
to ensure rapid development and quality outcome?
SMART QUALITY & COMPLIANCE
SMART is the KVALITO way of managing Quality and Compliance in the Industry. Using SMART, we build global and local regulatory requirements and industry standards into business processes to build trust with regulators. Organizations benefit from this approach by having low impact during operations and achieving a high output and value. We apply a risk-based approach to ensure our clients’ needs are fully met. Using lean implementation methods, industry best-practice and standard templates we achieve the highest quality outcome.
TRANSFORMATION AND CHANGE MANAGEMENT
Due to changes in corporate strategy, new technologies, mergers, acquisitions and divesture, businesses change more frequently and in more fundamental ways. We help our clients to master their change and transformation with focus on efficiency, quality and compliance. We enable effective and secure transition of the organization, its’ processes, data, and applications.
We ensure minimal disruption to the business, compliance with external regulation (GxP, Data Privacy, Security, Integrity, SOX) and internal processes. We guarantee effective and efficient management of risks and documentation and provide effective and efficient communication with relevant stakeholders.
By understanding your business and its‘ underlying risk exposures, we show you how to practically translate regulatory requirements (GxP, Data Privacy, Security, Integrity, SOX) into management actions whilst ensuring minimal disruption to business operations and internal processes. We guarantee effective and efficient management of risks and documentation and provide effective and efficient communication with relevant stakeholders.
AUDIT AND ASSESSMENT
Audit & Assessment is the entry point into Quality & Compliance. KVALITO experts provide business & maturity assessments and give you an open view and a clear understanding of where your business stands today. An assessment is your first choice if you plan to transform, standardize or simply bring your business one step forward.
Assessments provide a view on the maturity of an organization. Our experts conducting assessments have extensive experience in audits and the abilityto perform various level of assessments.
Our clients value the level of detail we deliver in
our reports, but also recognize the benefit of reviews delivered based on economical aspects.
The action and remediation plans are risk-based
and pragmatic.
STRATEGY AND ADVICE
A strategic definition works better when viewed from an outside perspective. We want to know your business goals and company specifics first, so that we can put the IT Strategy into the right context. With the focus on our smart quality & compliance approach, we aim to create strategies that simply work for you.
Market innovations and changes to regulations require a thorough view on quality and compliance standards within an organization. To keep up with changes and market requirements the Business Strategy will drive the IT Strategy and the IT Strategy will enable the Business Strategy to succeed.
A Digital Strategy is the enabler for many business opportunities and growth. The challenge is to determine the right technology mix and ecosystem, to achieve cost-effective implementation and operation. Our strategy consultants know how to master this challenge and combine solutions with smart quality and compliance.
BUSINESS EXCELLENCE AND CONTINUOUS IMPROVEMENT
The KVALITO definition of Business Excellence is simple. How does a business run effectively and efficiently to become world class without neglecting quality and compliance? KVALITO’s holistic service approach identifies business needs, determines solutions to your business problems and implements governance frameworks.
We design and implement Quality Management Systems including the definition of required operational processes. We build frameworks based on best practices and applicable regulatory requirements.
We turn your digital and mobile landscape into a structured and standardized ecosystem. Choosing the right ecosystem can be confusing considering the various suppliers and numerous technologies on the market. KVALITO helps you to master this challenge and supports you to choose the right platform, select the right technology and design the right digital strategy to achieve mobile excellence.
A vital part of mobile excellence are digital management and processes, both executed according to best practice and standards. A seamless integration into existing company structures is achieved by leveraging existing support and infrastructure services and by adding best-in-class mobile management capabilities.
SPECIAL EXPERTISE
The KVALITO portfolio includes the provision of talented Interim Management and Leadership Professionals for regulated industries. We are a Strategic Partner for Temporary Provision of Business and IT Executives. We are working together with talented general executives as well as subject matter experts who are qualified, trained and prepared for our client needs and requirements.
Our professionals are equipped with skills according to business needs and beyond expectations. We ensure backup leadership and management services whenever our client needs us. Furthermore, our professionals help to add value, reduce costs, and increase efficiency.
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As a member of the board of directors she is responsible for the financial activities and the strategic long and short term direction of the company. She holds a diploma in business economics. Prior to founding KVALITO, she has managed strategic, multi-national projects in the pharmaceutical industry, spanning for more than 100 countries, with an investment in excess of millions of dollars. Within these projects, she had responsibility for Quality, Risk, and Compliance across the regulated environment, including 21CFR Part 11 and Annex 11 compliance, and audit readiness. In addition to her professional experience as lecturer and coach, she has in-depth knowledge of, inter alia, validation principles, software development best practices, and quality management systems used in an FDA/EMA regulated environment.Magdalena Kurpierz
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Lara Bartlett holds a degree in Law and Anthropology from the University of Keele, in the U.K. and has gained strong experience in private practice in London's magic circle firms, U.S. firms in London and Geneva, as well as in the pharmaceutical and agricultural industries in Basel. Lara has worked in commercial contracts, trademark protection, software copyright/anti-piracy, corporate and regulatory fields to support the legal function. Lara supports KVALITO employees with employment contracts Social security, migration and related issues, and reviews/drafts SOPS and company manuals.Lara Bartlett
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Anna-Lena has over 4 years’ experience as a Life Science professional and as a research associate (PhD student) in management of data integrity, research projects, analysing data, teaching students, giving scientific talks, writing scientific publications, working independently as well as part of a team. She has practical experience in Regulatory Affairs of in vitro diagnostics (IVD) and Quality Management, EN ISO 9001, EN ISO 13485, IVDR (98/79/EC), technical documentation, SOPs, registration of IVD products. Anna-Lena has received professional training in Quality Management, Audit, GMP, CAPA Management, Process Management, Project Management. She has working experience in the pharma industry on Data Integrity including Data Mapping, Gap Assessment, Risk Analysis, interviewing production personnel, suggesting of respective CAPAs by applying ALCOA principle, based on FDA Data Integrity Guidelines, cGMP. Anna-Lena has an open-minded personality with excellent communication skills and intercultural competence. She provides management, coordination and execution of Gap Assessments and Data Maps (data flow diagrams) to identify Data Integrity risks for all Drug Substance production processes in close alignment with Quality Department and definition / suggestion of respective CAPAs by applying ALCOA principle. She can contribute to the development of efficient and FDA-compliant Data Integrity solution to meet project / regulatory requirements within aggressive deadline. Anna-Lena can also provide harmonization of documents and alignment with project work streams (equipment, computer systems, lab processes) to ensure global implementation approachAnna-Lena Hurter
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Leo has spent the past 35 years gaining in depth experience working internationally. He has worked as a Project Quality Manager with ICE Silver certification in Pharma IGM GxP Projects (including GAAP , GAMP, V model and SDLC ). He is a Business Excellence Leader (Lean Six Sigma) in Automotive, Finance, IT, Production, Telecommunications, Pharmaceuticals and FMCG. Leo has contributed to the transformation of companies processes according to customers’ requirements, managing various global projects with direct impact on P&L. Leo has provided leadership of Business Project Management Office with over 100 project leaders. He has introduced Crisis Management and Business Continuity Plan to several companies. Leo has executed Turnkey Telecom Projects including Mobile Network Backbone Microwave and solar power systems; Testing and Validating Computer Systems (CSV) and integrating into live network. He has also setup and provided management of local regional offices in several countries on different projects Leos Personal values & skills are: Integrity • Always focused on the customer • Excellent business acumen combining strong operating process skills with entrepreneurial mind-set • Strong people leadership able to energize and inspire teams around a clear, simple and exciting vision • Smart strategic and analytical problem solving skills • Global player who enjoys leading change. Leo is fluent in Dutch, English, German, Basic Czech and improving!Leo Bally
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Elizabeth Brown is a graduate from Shannon College of Hotel Management and has a wealth of experience in sales in the hospitality, and other industries both in Europe and internationally. She has lectured in Sales, marketing and business practices and has successfully run outbound and field sales teams. Elizabeth joined KVALITO Ireland Ltd in 2017 and is working to grow the business both in Ireland and globally. She works with clients to understand their specific requirements to ensure KVALITO provides the best resources to allow the client to achieve their goals.Elizabeth Brown
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Jessica HauswirthJessica Hauswirth
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Chewbacca the Apprentice is our Chief Office Dog and our Number 1 employee. He is currently on a strict training programme with regular behaviour reviews. Achievements are rewarded from the treat bag. (He’s never once mentioned a pay rise!) Our furry friend’s main responsibility is to help reduce our stress levels in the office and keep us all calm. He gives us paws for thought which helps us stay fresh with our creative thinking. He’s great to bounce ideas off and always seems to agree with us! Chewbacca is in charge of fun & playtime in the office making us take a break from using our brains so much. He keeps us fit by making us switch our laptops for leads and sees that we get our daily walks in – whatever the weather! Who can say no to those puppy eyes? He is the only one that gets away with having a nap in the office and not having to dress for the occasion. Chewbacca ensures we have a Quality worklife at KVALITO.
Chewbacca