Computerised System Validation (CSV)
Computerised System Validation
Core competencies in Computerised System Validation
- Risk assessment and approval: Every new computerised system undergoes a thorough risk assessment and documented approval process.
- Software validation: Ensuring your (critical) software meets all regulatory requirements and validating changes efficiently, including spreadsheet validation.
- Continuous monitoring: We continuously monitor software changes made by manufacturers or operating systems and validate them automatically.
- Repository solutions: Our cloud-based CSV platform offers a centralised overview of all software and hardware components and if required also spreadsheets, providing interested parties with full transparency and access at any time.
- Audit readiness: Your IT environment remains audit-ready at all times, freeing up internal resources.
The EUMEDIQ advantage
- Unique CSV portal: Our cloud-based CSV portal ensures seamless collaboration between you, your IT partner, and EUMEDIQ.
- Scalable solutions: From basic documentation to comprehensive validation, we provide flexible and customisable service packages.
- Security and efficiency: We mitigate risks from unplanned system failures due to changes, ensuring that operational continuity is not disrupted by IT changes and that your validation status is always up to date.
- Expertise and relief: No need to hire expensive CSV trained additional staff – we take full responsibility for CSV requirements and maintenance.
Who benefits from our CSV services?
- Small and medium-sized companies in the MedTech sector without in-house CSV or IT expertise
- Manufacturers seeking to ensure audit readiness and seamless validation regarding software and computerised systems
- Companies in regulated industries requiring GxP compliance
Typical challenges we help address
- Maintaining validation status during software updates
- Ensuring audit readiness and compliance
- Conducting risk assessments and revalidations for system changes
Why Computerised System Validation (CSV) is essential
Stress-free CSV solutions tailored for your needs
EUMEDIQ offers comprehensive CSV services tailored specifically for small and medium-sized enterprises and manufacturers in the MedTech industry that lack dedicated IT or quality assurance expertise regarding Computerised System Validation. For instance, we address challenges like ensuring eQMS platforms remain compliant when software updates occur, validating changes in document management systems (DMS), or ensuring non-specialised yet widely-used software like Adobe Acrobat remains secure and aligned with regulatory standards to maintain operational business continuity. We combine deep knowledge of IT management and quality assurance to ensure your business environment always remains audit-ready and secure. On top, we maintain software repository with all required records on a cloud-based solution accessible for defined groups.
In addition, we ensure qualitative service agreements in order to meet state-of-the-art IT requirements from your service providers.
If you or your IT service partner is using Microsoft Intune for device endpoint management, we can tailor our service accordingly.
Why choose EUMEDIQ?
Our experienced team understands the criticality of your products and processes. We provide:
- Comprehensive documentation and validation in collaboration with you or your IT partner
- Proactive monitoring and quick responses to software changes
- A sustainable and secure operation of your IT environment
Act today to stay ahead of regulatory demands.
With EUMEDIQ as your partner, you can confidently navigate the increasing complexities of CSV and audit readiness.