Deviation Management with advantum
Deviation management can be a time-consuming process. In advantum you can automate many manual tasks that are involved in the process. Using advantum will allow the organisation to control many different types of deviations, both internal and external, such as production related, supplier control, health & safety or reclamations.
The configurability of advantum allows for complete freedom to put your organisations way of working into the system to 100%
The following examples of standard functions in advantum are most commonly used to make the deviation management process more effective:
- Automatic registration of existing data
- Pre-select lists of choices to be made to assist the user to fill in correct data
- Pre-defined workflows will decide a clear path of how the case is routed in the organisation
- Notifications are sent automatically to relevant personnel, through e-mail or messages directly at login
- Alarms will escalate the case if no progress has happened within the given timeframes
- Status and access control ensures that the correct person will get access to correct information at the right time
- Version controlled relations can be made between deviation and other objects such as customer, process, product, project, production line, facility or other documents such as deviation report, planned deviation, e-mail
- Reports can be automatically generated, event or time driven
- A graphical interface will enable responsible personnel to follow the case through the different process steps.
- An un-tamperable audit trail is standard to trace all events. This audit trail fulfils the highest level of compliance today within the nuclear, financial and pharmaceutical industry.
- The system can include processes such as Corrective and Preventative Action (CAPA)
- Electronic Signatures and Records enable users to approve deviations directly in the system according to EU-GMP and US cGxP regulations and FDA 21 CFR part 11
- A full API enables the system to directly communicate information to or from or both ways, with other machines or business systems to reuse existing data effectively and eradicate multiple input of data. This function can also be used for electronic batch records process
