Quality

ARONE is constantly seeking to fully satisfy its customers by providing top-quality solutions that best meet their needs in the shortest possible timelines. In line with this, ARONE has acquired specific tools to enhance its agility and measure customer satisfaction.

A robust quality system

ARONE has developed and implemented a quality system based on written procedures. Each task is described and all standard tasks are documented.

Knowledge base

Each member of staff has access to the company's knowledge base and can therefore draw on the experience of all, and further add to this experience (optimizing timelines and guaranteeing success). The knowledge base is available on the ARONE intranet and searches are made by key word.

Controlling the development cycle

Each an every project entrusted to ARONE receives the same quality assurance care and attention. User requirements are listed systematically and added to those provided by the customer. Each requirement is listed.

Several validations guarantee that the system developed complies with the requirements. For instance, when developing an eCRF, an initial validation is conducted immediately after setting Designer parameters, a second is conducted once the Designer has generated the pages, and the final validation takes place once data entry controls and specific coding rules have been set up.

All project-related documents (from User Requirement Specifications to Installation Qualification) may be sent to the customer or stored by ARONE. Project documents may be audited during or at the end of the project.

Audit

ARONE is regularly audited by its customers and capitalizes on each one to further improve its system. These regular audits and the company's organization in project teams mean that all members of staff are fully aware of the importance of quality and documented procedures in the pharmaceutical industry.

Personal and personalized organization

ARONE allocates a Project Leader to each of its projects, working in close collaboration with the customer. This Project Leader manages all project-related work from initiation to production. This collaboration between the Project Leader and the customer eases the development process and enhances quality.

Compliance with 21CFR Part 11

ARONE systems are compliant with the requirements of 21CFR Part 11.

In particular, they include electronic signature and a full audit trail. All systems are fully validated.

Regulatory compliance

ARONE complies with the recommendations of GAMP guidelines for each step in the development cycle.