In the pharmaceutical and medical device industries, the use of cloud-based systems (SaaS) is becoming increasingly common due to their advantages in terms of flexibility and scalability. However, these systems are constantly updated according to the schedules set by the providers, which can lead to the validation status becoming obsolete and pose challenges in terms of regulatory compliance.
Introducing ManVa: continuous validation maintenance
To address these challenges, Ambit Iberia offers ManVa, a service dedicated to maintaining the validation status of your cloud-based systems. We handle the continuous assessment and validation of updates to SaaS platforms such as Tracelink, eCTD, pharmacovigilance and training, amongst others, ensuring that your systems comply with current regulations at all times.
Key benefits of ManVa
- Continuous assessment of updates: we analyse every new version or system update to determine its impact on regulatory compliance and your organisation’s processes.
- Automated validation: we implement standardised procedures for the efficient validation of each update, minimising downtime and ensuring compliance.
- Comprehensive documentation: we provide all the necessary documentary evidence to support the validation status, facilitating audits and regulatory reviews.
- Resource optimisation: by outsourcing validation maintenance to ManVa, your team can focus on strategic activities, whilst we manage technical and regulatory compliance.
Tailored services for your business
We understand that every organisation has specific needs. That is why we tailor our services to align with your objectives and specific requirements, ensuring bespoke solutions that optimise the management of your cloud systems.
Commitment to excellence and regulatory compliance
At Ambit Iberia, we keep up to date with the latest regulations and industry standards. We are committed to providing you with tools and strategies that ensure your SaaS systems comply with all applicable regulations, minimising risks and ensuring continuous, compliant operation.
Trust ManVa to maintain the validation of your cloud systems and ensure regulatory compliance efficiently and effectively.
