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Ennov5 Solutions for Life Science Industry
Ennov provides a single solution to create and approve regulated content and ensure secure, accurate maintenance of operations documentation and records.
Over the years regulatory scrutiny has been increased. Each country develops its own specific requirements, but US and Europe based regulations apply to all life science companies willing to propose their products in these markets. In addition to a rigorous regulatory environment, life science industries have to deal with long term research and development cycles, harsh competition, and expiring patents. Accelerating a products time to market is key to their success. One of the overwhelming obstacles to speed to market is the preparation and review of documentation associated with regulatory validation. With Ennov it is easier and faster to create, validate, track, manage and report your documentation. You can demonstrate you have the systems to exceed standards for documentation control and management.
Assisting Regulatory Affairs - Dossier Submission
Regulatory affairs are in charge of managing the submission process that will end in local agencies authorizing a new product in their market. Authorization is subject to examination of a submission dossier. Ennov proposes a complete solution to computerize and secure dossier generation and submission process. Ennov5 enables companies to design their dossier backbone, drag and drop documents to the backbone, supervise single or grouped validation cycles, eventually assemble and publish automatically the final dossier (e-CTD management). Such a solution applies to all submission or batch dossiers, and more generally to all manufacturing dossiers.
Mastering Corporate Know-how - Publishing Reference Documents; Reporting and Tracking Issues
To stay compliant with internal standards, external standards and regulations, life science companies strive to control the way SOPs, working instructions and test records are being published and distributed. Ennov5's EDMS offers a quick, efficient and simple answer that ensures users can access the latest version of a document required, while automatically archiving former versions. Validated documentation is categorized and displayed according to the users' profile making it easy for them to retrieve.
In addition, the Ennov solution enables life sciences companies to monitor issues, reporting and tracking. All issues from manufacturing deviation to customer complaints can be managed by the system. It is easy to originate, review, respond and resolve issues. The system even allows for ad hoc e-forms. Pre-designed workflows streamline the issue handling process and maintain records of all analysis performed and actions taken. The system makes sure action plan are completed before issues can be closed. Complete audit trails feed back performance indicators for business analysis and efficient set-up of preventive action plans. Internal and external audits can be managed the same way.
Mastering All Key Business Processes: The Example of Product Launch
Competitive factors put life sciences companies under pressure to accelerate time to market while maintaining product quality. Thanks to its extreme flexibility, the Ennov solution can match any business process. With Ennov no IT skill is required to design a product launch process combining many mandatory and optional steps. Ennov can also support the marketing process for new products by delivering the right piece of information to the right person. This may include partners for pharmaceutical firms, doctors, medical representatives, scientific reviews, etc. The cosmetics firm PUIG uses Ennov to automate and manage its product launch process.
Regulatory Compliance: 21 CFR Part 11
Title 21 of the Code of Federal Regulation applies to all companies that wish to market a new drug in the United States. It describes conditions under which the FDA accepts computerized records and concerns all companies that use IT systems in relation with cGMP (Current Good Manufacturing Practices). Main concerns are audit trail for all data and authenticated validation. To ensure 21CFR compliance, Ennov proposes an add-on module to manage secure connection, double signature validation and audit. This solution is deployed and used by Sanofi-Aventis and Linde Gas.
In addition, Ennov can help companies achieve their regulatory compliance to the new European REACH program.
An example of installation worldwide: Linde Gas