A controlled document distribution process - in which getting the right information to the intended recipients within a desired, or required, time frame and being able to track delivery status and confirm receipt - is a challenge for regulated industries. Life sciences companies, regardless of whether they do business globally or regionally, continuously face many reporting obligations, a very prominent example being reporting on adverse drug reactions or adverse events.
Whether the data originates from marketed drugs or from clinical studies, the documents must be delivered to a variety of recipients within a predefined time frame, using predefined methods of delivery and required formats. All this must take into account the relevant global, regional or local regulations, as well as recipients' internal business requirements.
A reliable, fully automated system allowing efficient management of reporting obligations that is not only accepted by all recipients but is also compliant with all applicable regulations is the preferred way of supporting such a process. To get the most out of a distribution solution, flexibility needs to be built into the system in numerous ways:
- The system must be able to receive data in different formats and through different routes.
- Distributions should be logged and process steps must be monitored and visualised. This is critical where regulations on electronic records, such as 21CFR Part 11, apply.
- To handle error conditions, it should be possible to define escalations, such as using alternative routes of distribution and producing related warnings.
- Flexible delivery methods must be available based on the needs and circumstances of the recipient - for example, email, fax or courier.
- Successful deliveries must be tracked with minimal effort.
- A dashboard that provides quick and relevant information on system, distribution and acknowledgment status is desirable.
- Implementation needs to be easy; ideally no training and maintenance will be required.
- The central process must be accepted by all recipients.
pharmasol's psiXchange establishes the relations between data from multiple sources, making your data actionable.