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ENNOV

Medical Device and Drug Development Compliance Specialists

More info about ENNOV

Certification

ENNOV

Does your company aim to achieve quality certification or is it already ISO certified? Computerizing you quality system will help you achieve this goal by helping your organization be more cost-effective and shortening processes making them more accurate. Ennov5 is the solution you need.

A quality certification provides unquestionable advantages when competition is fierce. Because customer and regulatory requirements is complex, it is essential you choose a solution that is cost effective and comprehensive to your business needs. In many sectors the decision for companies and consumers to do business with you depends on whether or not you can prove your quality. With Ennov Solutions you not only enhance your company’s position in the market, you insure you take steps to protect yourself from governing agencies claiming your damaging the environment. Companies acting in the pharmaceutical, healthcare, food, environment or even manufacturing sectors have to obtain quality certificates to prove their activity is geared by sustainable development concerns.

Certification, what is at stake?

To be certified a company has to:

  • Manage its activities according to an authorized quality programme described in in-house documents, such as quality manual, procedures, work instructions, records and documented quality processes
  • Develop internal means to make sure all employees are informed of the appropriate way to perform their tasks
  • Make sure internal processes are described, conform to quality standards and are executed properly
  • Regularly control its conformity to quality requirements through audits, management of deviations from documented process, establishing corrective actions and execution of action plans – quality indicators should be set up, analyzed and reported on to show conformance

How can Ennov5 help you?

Thanks to its wide range of features Ennov5 provides complete computerization of all needs described above. Ennov5Doc manages all quality documents. Version changes are managed and validation cycles automated. It secures well targeted distribution of documents to employees and partners. Information is made available, accurate and up-to-date. Every employee has access to the right documents and his/her awareness can be tracked.

Ennov5 Process enforces righteous applications of internal processes. Thanks to electronic forms, key information is recorded and processed. Ennov customers most commonly computerize the following processes:

  • Tracking of non conformances
  • Management of customer complaints and corrective action / preventive actions (CAPAs)
  • Audits
  • Additional support processes such as training requests, records, validation of expense sheets, etc.

Ennov Datamart is a key module to integrate the Ennov suite into your business intelligence global solution to provide your managers with real time indicators about the organization quality level. Users will select processes to be analyzed and ask for comparisons between target performance and achieved results. Different analysis lines might be defined and simulation added in order to deliver the best information possible. Automated dashboards can be made available to all employees authorized through intranet publication.

To keep one’s certification once granted, regular internal audits are necessary. Ennov5 helps you prepare, schedule and supervise all audit phases including effective closure of deviations detected and associated actions.

To summarize

Ennov5 is a world-class solution to streamline your certification program. As a matter of fact, quality is a field of expertise for Ennov. No matter what industry nor standard your company is related to, no matter what processes you are mostly concerned with – customer claims, deviations, adverse events, financial audits or 21CFR compliancy – Ennov5 is meant for you. As an acknowledgment of this expertise Ennov5 was integrated in 2007 into the EMC Partners portfolio as the only “out-of-the-box quality package” certified for EMC Documentum.

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