Icologiq Elements in Life Science
Icologiq offers EQMS software which enables companies in the Life Science sector to meet strict rules without being hindered in their innovative capacity and productivity. Icologiq offers standard solutions that meet the FDA requirements such as 21 CFR Part 11, digital signature and the worldwide normalisation of processes.
Icologiq offers solutions in the following areas:
SHE Management supports the entire process of incident (event) and action management. Registration of events, a dispatch function, root-cause analysis, preventive/corrective actions and verification are some of the workflow steps that are supported within the module. An authorised business analyst or key user can define new types of events and workflows based on templates.
Proposals for improvements are led through the organisation based on a workflow in this module. If and how an improvement could be made can be assessed from every viewpoint. Since improvements are translated into implementation (workplace) through Icologiq Elements, complex mutations that affect multiple processes and multiple departments can be rapidly and effectively implemented throughout the organisation.
Risk Management (Fine and Kinney)
Based on a generic deployable risk matrix, all types of reports can be assessed on their potential risks. Risks can be managed top-down thanks to continuous monitoring of the status of all prioritised risks.
Icologiq offers a complete standardised framework of configurable solutions for this:
Icologiq Elements captures all risks, creating insight into their frequency. The status of proposed improvements that must prevent risks is also captured. Thanks to this continuous feedback between the formulated policy and its implementation, you remain informed if improvements are actually being implemented.
Law and Regulations
Icologiq Elements standardizes all processes that relate to the management of risks and safety. Naturally, this standard incorporates all applicable legislation and regulations. By managing risks and safety with this platform, you know exactly whether you are compliant. A dashboard provides insight into fields requiring measures/actions and indicates the priorities.
Digitalisation of processes is a priority in many sectors. Digitalisation also plays a dominant role in the Life Science industry as it allows the entire chain to be closed end-to-end. Icologiq supports organisations with applying FDA 21 CFR Part 11. This is an application of electronic data storage and electronic signatures allowing processes to be more efficient.
Do you want to learn more about a solution for your industry? Please contact our consultant.