More Than Standard: Comply with All Standards of the CSV
We offer know-how and support for comprehensive Computer System Validation (CSV) and Quality Assurance (QA). For this purpose, we develop company-specific CSV strategies for you or train your employees in all questions of successful validation. In this way we make your company fit for the future and for the various regulatory requirements. Whether 21 CFR Part 11, Annex11 or GAMP5, whether GxP or Data Governance, with our experienced team of experts we take over all tasks that are necessary for a rule-compliant and good implementation of your IT projects and systems.
With our extensive experience in all IT processes in life science, we always succeed in developing the best validation strategy for your IT projects. With many years of validation experience in the regulatory environment and with various companies in the research and pharmaceutical industry, our CSV experts can provide you with comprehensive and competent advice.
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With a highly qualified team of experts and best customer references, we know the challenges and demands that are placed on the development and validation of computer systems and IT in the regulated environment - for both SMEs and large international corporations.
We Offer You These Validation Services:
Project Quality Management
"Valid validation projects thanks to expertise and experience"
»Termingerecht und entsprechend den Anforderungen sowie Qualitätsstandards«
Project Quality Management
In an increasingly complex IT landscape, CSV is a challenge for many companies. Whether you lack in-house resources to implement the validation strategy with your QA (Quality Assurance) in your IT project or whether the costs for validation are too high - with us, CSV and quality management become a cost-efficient routine through the right validation strategy and the customized implementation plan.
We provide you with long-term support for the entire validation process or short-term support for an upcoming rollout date. You benefit from our know-how from many successful validation projects and our best practices. You can rely on the timely completion of projects with the highest quality standards and on our working methods, which always comply with regulatory requirements (21 CFR Part 11, Annex 11) and standards (GAMP5).
These Are the Services We Offer:
- Preparation, execution and finalization of all validation documents (validation plan, URS, FS, etc.)
- Preparation, moderation and finalization of the functional risk analysis
- Creation of test plan and test cases for IQ, OQ, PQ
- Test and validation report
- SOPs for system management and users
CSV Governance
»Valid reports in accordance with official requirements«
»Highly trained team of experts with experience in the regulatory environment«
Computer System Validation Strategy
Whether you want to develop a CSV strategy tailored to your company or optimize your existing processes, we use our experience and expertise to develop validation strategies according to your needs and requirements. We examine whether you are well prepared for internal and external (e.g. EMA, MHRA, FDA) inspections and audits and support you in anchoring operational CSV templates and strategies in your company.
We tailor your validation to the type and size of your organization. The validation plan and validation report are adapted to the relevant regulatory requirements. In addition, we conduct all necessary reviews of your SOPs and make suggestions for adjustments and updates. In this way we make your company ready for the next inspection.
We Offer You Complete CSV Governance:
- Gap analysis in relation to 21 CFR Part 11 / Annex11
- Adaptation or new creation of a CSV SOP, which describes and specifies the strategy for the validation of computer-based systems
- Adaptation or creation of all required CSV templates (URS, FS, FRA, Validation Plan, Validation Report, Test Plan, Test Report, IQ, OQ, PQ)
IT Supplier Audits
»After 25 years, we know the best and most reliable suppliers.«
IT Supplier Audits for more Security in Supplier Selection
Use our expertise and our network to select your IT suppliers. We will work out an individual IT supplier audit for you. This gives you more security in supplier selection and supplier qualification and, with our network, also the best partners.
As an international IT service provider, we are optimally networked. We know most of the software manufacturers as well as integration partners for the configuration of customer-specific adaptation. Thus we offer contacts and know-how for comprehensive and reliable IT supplier audits - also for software manufacturers or project partners for the life science industry.
We Offer CSV and IT Personnel with Know-how:
- Preparation, improvement and documentation of internal and external audits
- Implementation of audits for your IT systems under GxP
- Planning, implementation and reporting for IT suppliers, audits of software manufacturers, cloud service providers, etc.
CSV and Data Integrity Training
"Training with added value and experience"
CSV and Data Integrity Trainings
We make your employees fit for your CSV and data integrity issues. Whether you want a good overview of all activities in CSV or a refresher course with the latest developments in IT validation, data integrity, we offer training with content tailored to the needs of your organization.
Our trainings are conducted by experienced trainers and CSV professionals and cover all important topics such as data integrity, business continuity, disaster recovery and audit trail review. This way we make your employees fit for the various requirements in the CSV environment in a short time. You get to know the current developments and topics and can put what you have learned directly into practice.
We Offer CSV and IT Validation Courses:
- "CSV Basic" and "CSV Advanced" at your premises or in Basel. Learn more
- Data Integrity Training
- customized trainings according to your wishes
- experienced CSV trainers with pharmaceutical / IT background
Audit Trail Review
"Maximizing efficiency while ensuring GxP compliance"
The holistic approach of modular services
The current data integrity guidelines (FDA, MHRA, EMA) as well as the corresponding inspector practices have put the emphasis on perfect data integrity.
Therefore, it is necessary to have a complete understanding of the audit trails and accordingly define the optimal and most efficient process for the audit trail reviews in your systems.
We offer the following services:
- Analysis of the previous audit trail strategy
- Data evaluation & optimization of your processes
- Configuration of your Audit Trail Review automation
Support for audits and inspections
"This makes inspection routine"
Identifying deviations and weaknesses before an official inspection is better and easier from both a financial and reputational perspective. Improvement measures can be defined and then implemented through targeted mock inspections, often also through inexpensive and simple evaluations.
The situation of an inspection is very stressful. It is therefore important to train employees on how to behave in this kind of a situation. In addition, professional preparation gives you a safe feeling during the inspection.
We Offer the Following Services:
Company specific awareness trainings to coach
employees at all levels
- Compliance assessments of computerized systems
and processes - Pre-inspection audits to assess the compliance state
and readiness level - Formal CSV/GxP audits, supplier audits, which
primarily focus on the identification of weak points - Mock inspections, in which the situation of an
official inspection is simulated - Support in the planning of corrective measures following inspections and in the preparation of audit responses
Agility in regulated / GxP environments
«wega supports your team in managing the challenging transition to a successful agile validation methodology«
Our world is becoming increasingly complex, volatile and less predictable. Dramatic changes cross the boundaries of pure software development and affect entire companies. Even in traditional, non-agile environments, such as validated projects, they must deal with rapidly changing requirements, planning challenges and volatile business demands. New ways of working, collaboration and value creation are required.
Especially in regulated or GxP subject environments the situation is complicated and demanding and interdisciplinary teams have to work together efficiently.
We Offer the Following Services:
- Modular and individual on-site workshops for your specific needs: Agile Basics, Agile Validation, Agile Mindset, Scrum (introductory and advanced courses)
- Agile process development, starting with the actual processes and the validation strategy, followed by a target definition based on the agile basic principles
- Consulting services and staffing consisting of Certified Scrum Masters, Agile Coaches as well as Scrum Certified Validation Experts, Business Analysts and Software Engineers
Validation of Laboratory Data Systems
»We know the regulatory requirements in the clinical and pharmaceutical fields.«
Highly Qualified Lab IT and CSV Specialists Who Fit into Your Team
Data integrity is increasingly becoming the focus of surveillance authorities in Europe. Whether GxP or 21 CFR Part 11, Annex 11, validation - high demands are placed on computer-aided systems and data governance within the framework of a pharmaceutical quality system. Lab data systems are becoming more complex and yet there are often too many manual activities that involve potential sources of error.
We know exactly what data integrity requirements are and identify existing gaps in your current laboratory processes. Together with our Lab & Research IT specialists, we develop efficient and modern IT solutions - compliant and future-oriented. From Audit Trail Review and Segregation of Duties to Disaster Recovery and Change Management, we support you in the validation of your IT systems with a focus on the next regulatory inspection.
We Take Over the Following Tasks for You:
- Validation of laboratory IT systems for quality control (QC), laboratory IT systems for development laboratories (GLP, GMP)
- Validation for systems such as Laboratory Information Management Systems (LIMS), Lab Execution Systems (LES), CDS, Titration System etc.
Medical Device Compliance
"Efficient work processes thanks to the introduction of a paperless quality management system in accordance with ISO 13485."
"Benefit from our expertise in IT and regulatory processes when developing medical software."
Validation of Medical Software
Technology and digitalization in the healthcare industry are advancing rapidly. Combined with current IT trends such as AI, mobile apps and smart devices, cloud systems, etc., there are huge opportunities for medical software developers (medical device software and stand-alone software). At the same time, regulatory requirements and standards are constantly evolving (MDR, IVDR, ISO 14971, ISO 13485, IEC 60601, IEC 62304, IEC 62366). Developing software that is compliant with medical device regulations is an increasing challenge.
We support you through the software lifecycle with our expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. You benefit from our extensive knowledge in IT and regulatory processes in life science on the way to the release of your certified medical device software.