Meeting your full periodic and aggregate reporting obligations

Periodic reports—PSURs, ASRS, and Risk Management Plans (RMPs) not only help to ensure regulatory requirements are met in a timely manner, they also provide the opportunity to document a product's safety profile as it changes over time.

As with all Aris Global products, agComposer is available as a hosted solution on the agOnDemand platform. For more than four years, agOnDemand has been providing best-in-class, cloud-based services to life science companies to help them meet their regulatory requirements without the pressure of maintaining sophisticated IT infrastructures.

Maximizing safety & minimizing risk

agComposer automatically sets deadlines and reminders to ensure that an organization’s reporting obligations are met on time. As a periodic or aggregate report comes due, it can only be generated in cooperation with other departments. When a user completes a section, the report owner is instantly notified. A simple workflow capability allows the report owner to determine which users are responsible for authoring, reviewing, or approving the content. When all respective sections are approved, the owner can publish the final submission ready report.

agComposer offers users a variety of pre-defined templates. Templates can be created comprising chapters and sub-chapters then reused based on the type of periodic report needed. Other key features include:

Delivers business value

agComposer fully integrates the required departments and processes to ensure deadlines are met and that reports meet the requirements of the respective regulatory agencies. The following are just a few of the key benefits that agComposer delivers: