Digital Validation offers a holistic management of the entire validation process. Digitizing this is more than just eradicating paper. A true digital transformation process will leverage the power of data, enforce best practices and standards, and enable data integrity governance in the corporate validation process.
Digital Validation is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements and is delivered as a Software as a Service solution. This means that is multi-browser compatible with an online editor; enables a collaborative review of documents (through the online editor); provides portability (supports mobile devices such as the iPad and Surface across authoring, execution and review stages); and has enhanced system assessment features that integrate GxP assessment, validation standards and risk assessments.
The solution incorporates a range of characteristics and functions designed to significantly improve the traditional validation approach:
If you want more information about Digital Validation don't hesitate to contact us. Our team will be delighted to answer all your questions.
The Life Sciences industry has the same drivers as other industries to continually assess the effectiveness of processes and to lower associated costs, however, historically in the compliance and quality field, Life Science companies have been reticent in adopting a managed services model. It is always a question of how to justify this model to the regulatory agencies when they come calling.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business or the manual approach to validation.
Over time the traditional validation activities have become centered on documentation, which has increased and led to additional quality issues. For the most part, validation still requires a high degree of manual effort, for tracking and reporting, and the execution of most validation protocols takes place on paper.
We have developed a cost-effective and scalable method for the validation of computerized systems.
It covers the entire system lifecycle – from initial implementation, through the operational phase, to decommissioning and data archiving.
The SaaS solution, Digital Validation, is designed to securely manage regulated validations, data and documents in the cloud. Digital Validation users can obtain the benefits of a comprehensive validation lifecycle management system in our own regulated private cloud, which offers high availability, scalability, agility, security and compliance with the requirements of IT operation and data integrity required by the authorities.
Nuestra nube validada cumple estrictamente los requisitos de la 21CFR Parte 11, el Anexo 11 del volumen 4 de la Eudralex, y los principios de la GAMP 5. Esta también se construyó de acuerdo con la IEC/ISO 9001 para la gestión del sistema de calidad, la IEC/ISO 27001 para la gestión de la seguridad de la información, y la IEC/ISO 27018 para la protección de la información de identificación personal.
The high consumption of paper, especially in the US, Japan and Europe, puts the planet's supplies on alert.
In fact, if the entire population consumed at the same rate as those 3 territories, there would not be enough trees in the world to supply this demand. To the obvious problem of deforestation, we have to add the high consumption of water that is necessary to produce the material.
Coexisting with nature is just our choice, so let's live sustainably. By adopting the Digital Validation solution, we will be helping to save the planet, which is the future we have left.
SAVE PAPER, SAVE ENVIRONMENT