ADIpharma

ADIpharma 2018-07-31T10:00:48+00:00

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ADIPHARMA BROCHURE

ADIPHARMA: PROCEDURES AND GxP PROCESSES MANAGEMENT IN A REGULATED ENVIRONMENT 

ADIpharma is a system that integrates the possibility of managing documental flows and Quality processes in a regulated environment. This solution has an Audit Trail and an Electronic Signature function in conformity with the FDA’s 21 CFR Part 11 and EU-GMP – Annex 11 requirements and has been develop according to GAMP 5 and all the staff are trained following the related guidelines.


BENEFITS

ADIpharma is a solution structured according to a parametric standard (Category 4 of GAMP 5) and it is suitable to be modelled on the already existing corporate processes. Thanks to its very intuitive and user-friendly interface, not only it has been rapidly accepted by the users and has registered an indisputable and proven increase in decisional and productive processes, but also it has encouraged a enhanced internal organization, a better relationship with suppliers and with national and international monitoring bodies. The Audit Trail module allows the extraction and visualization of all data in the system, resulting a strong optimization of quality processes and a higher degree of compliance. ADIpharma projects stand out for their short actualization time, reduced change management and competitive costs.


FUNCTIONALITY

Traceability and management of GMP documents

(SOP and Operative Instructions, MODULES, Monografies, Validation/qualification Protocols, Manuals, Master Batch Records, Methods, etc..)

  • management of the different versions of the document

  • management of redaction, verification, approval and release of the documents

  • management of digital and paper distribution of documents

  • traceability, controlled printing of documents and printing reconciliation tools

Traceability and management of GMP documents

(CHAPA, CHANGE CONTROL, DEVIATION/NON CONFORMTITY, COMPLAINTS, CLIENT INSPECTIONS, etc..)
A very flexible tool, able to support every activity related to the vital cycles of quality management processes, is provided through modules and dynamic forms. The system has a very powerful and versatile function: the formulation of lists of tasks to be performed according to the processes.


TRAINING

The launch of new procedures within the company generates a training activity for operators. ADIpharma provides a series of functions the allow to

  • keep track of who attended the training sessions and when

  • automatically generate training according to qualifications and position in the company

  • manage customized training plans

  • manage job descriptions


MAIN TECHNICAL CHARACTERISTICS

In order to be able to store hard copies of invoices, space has to be significantly increased. Electronic archiving and central management of documents reduce cost by more than 90%. Easy usage and rapid and constant access to information give the opportunity to save a lot of time and money. The immediate acceptance of the system by employees of different departments like sales, HR and accounting proves the validity of the decision of implementing an Electronic Documental Management system. For a large-sized, large-scale retail operating company management of passive cycle is crucial. In fact, thousands of invoices, issued by suppliers are sent to the centralized administrative office. Those invoices usually refer to products and services provided either centrally for distribution, through logistic storages, or locally, at retail outlets, in the case of perishable items. Invoices, each one or several pages, usually pair in the cycle with orders and contracts, mail and shipping notes.

CONTACT US,

FILL IN THE FORM OR CALL +39 0523/770077.

References