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Pharmaceutical and nutraceutical company with more than 700 employees and 3 plants in Italy.
Our Method for Success Stories.
Regulation
GMP legislation requires more efficient management of Change Controls.
Security
Documents related to Change Control have been scattered around the company are a long time
Delay
People are notified and are provided with the document late.
Quality
Paperless change control management generates stronger and more transversal quality across all sites. Adiuto guarantees the digitization of the flow according to current data integrity regulations.
Employee Appreciation
Employees can perform their job more efficiently. Adiuto follows and manages the change process, they have to deal with quality issues and not to chase the information.
Identification of waste areas on which to make processes more efficient.
Time for the resolution of processing errors
Unnecessary production or incorrect planning
Waste of time in the process steps
Inefficient allocation of resources
More work or higher quality not required
Inefficient handling of resources
Inefficient archiving or inventory
Unnecessary handling of products and materials
GMP inefficiency
The paper process makes it difficult to have the necessary signatures in the correct time. Adiuto made it possible to manage the process in a completely digital way.
Late signatures
The company is spread across multiple plants, and sending sheets around to alert people regarding necessary tasks and receive their signature is time-consuming and often causes delays. Adiuto allows instant alerts to the approvers for the necessary evaluations.
Quality Assurance: Qualified Person or the mailman?
To avoid losing documents, the Quality Assurance office, in addition to doing its job, would act as a mailman in the various plants, to capture the necessary signatures and not leave the Change forms unattended. Adiuto made it possible to send the information without having to move the paper, in total security and following Data Integrity compliance.
Poor traceability
The Quality Assurance office had extreme difficulty tracking change controls because the sheets were always moving around the company. Adiuto has made it possible to have a system that contains all the change controls compliant with data integrity regulations.
Solutions are identified, implemented, and customized.
Paperless management of the Change Control process.
Collection of electronic signatures from any location.
Definition and execution the necessary tasks list.
Adiuto manages the request for information and allows workers to collaborate on change control management by filling in the information and selecting and approving the list of necessary activities.
Each site's workers, the approvers, the Quality Assurance Department, and the management are the beneficiaries of Adiuto's solution.
Through the Adiuto workflow, operators can open change requests, Quality Assurance evaluates them, classifies them, draws up the list of necessary activities, tracks their completion, and the management closes the change by affixing the electronic signature when necessary.
A summary of the main advantages of the Adiuto solution presented.
Technological and methodological solutions for each critical process.
The solution for the management of corporate training in a regulated field
Read moreThe solution for digitizing GxP & GMP Compliant processes
Read moreApplication Areas of Process Management solutions.
Standard processes, standard activities, controls and inspections: digital quality according to Adiuto
Read moreIndustry 4.0 as a paradigm enabling the advantages of digital in production processes
Read moreGoverning the company by integrating regulations into processes and simplifying the organization
Read more