Pre-validated software and environment
All software used in the Life Science industry must be ‘validated’, which means that:
- It must be proven to meet its predetermined specification
- The software is used within a managed, documented environment by qualified staff
Ennov’s eCTD247 Essential and Premium offers are cloud based. Ennov takes responsibility for the functionality and quality of the software and its operational environment, so that you can concentrate on your regulatory affairs tasks.
The eCTD247 solution and the technical environment are ‘pre-validated’. Define your own working procedures and you are good to go.
We provide certification that it has been tested and installed according to predefined Standard Operating Procedures and that its use is secure.
Guaranteed quality and compliance
eCTD247 is developed, installed and managed under an accredited ISO 9001:2008 Quality Management System. It is designed to be operated in compliance with 21 CFR Part 11.
Validating a software application implies guaranteeing that the systems complies to GMPs and FDA‘s 21CFR part 11. Ennov proposes to its customers who wish to validate their solution a service by expert consultants.
Spare months validating your system
Many of Ennov’s 150 Life Science customers work with our consultants to be assisted in their validation process. Regulatory inspections are handled in the best possible way and time spent writing test procedures is limited to a minimum.
A dedicated validation service
We adapt our validation assistance service according to your project’s specific needs. We provide two service levels, which content can be adapted:
- Validation definition: Ennov writes the validation plan and advises the customer on the planning, definition of responsibilities and validation deliverables
- Ongoing assistance: Ennov participates to the whole validation processs with the customer (validation plan, risk analysis, design qualification, installation qualification, operational qualification, performance qualification, validation report, traceability matrix). Test execution and final decision of validation status remains the customer’s responsibility.