Software Process Management

Processes

The organization intended as company, according to the ISO 9000-2000 standards, must identify the important processes for the management of the Quality System and their application: lay down the controlling methods of these processes, assure the availability of the resources, execute measurements, monitor and analyse. The Process module of Quarta EVO allows to create, through the WorkFlow motor, non-preconfigured processes inside the Quality System of Quarta EVO. The Process Configuration menu allows the user to organize and plan each process according to their own requirements.
Each process needs objectives, liabilities, expected results, etc.

A Process in Quarta EVO is created through the following phases:

• process identification;
• definition of the information required for creating the module;
• giving a code and name;
• defining the input fields, retrieval tables and special fields;
• configuration of the “document flow”

General Characteristics of the Process module:

• Complete information configurability;
• Activity scheduling;
• Connection to other processes and/or to other structured documents of Quarta EVO;
• Attachment management in any format (text, images, etc.);
• Possibilities of retrieval using key words;
• Management of compound documents by displaying the father-son relation tree;
• Every manual or procedure has a life cycle and a workflow configurable during the drawing up (Processing, Check, Approval, Issue) and diffusion phases;
• Integration with E-mail: each user can be informed about document reviews by recieving a message in their mailbox, which automatically displays the received document with Quarta EVO and affix one’s own electronic signature;
• Displaying the history of the signatures for viewing and of the comments or feed-back;
• Evaluating the processes in terms of value added;
• Continuous improvement of the processes according to objective measurements.

• more productivity;
• punctual check of process’ phases;
• definition of roles and responsabilities of each operator;
• assimilation with other processes and/or other structured documents from Quarta EVO or other systems;
• trackability of data and informations even through the visualisation of the father-child bond tree;
• Sign history of document visualisations, of comments and of feed-backs in order to keep under control processes’ phases;
• evaluate processes analysis-wise to get a continuos improvement of processes based on 0bjective measurement;

Quarta EVO Project Management

UNI EN ISO 9001

UNI EN ISO 9100

UNI EN ISO 22000

UNI EN ISO 13485

UNI EN ISO TS 16949

IRIS

21 CFR PART 11