All processes already optimised

Discover the work processes we have digitised and optimised over the years. Explore our customers’ favourite packages. Create your own package.

Discover the packages of processes

Be inspired by the already digitised packages or create your own package.

Create your own package

Build your package by selecting the processes of your interest.

Audit (internal/external)

CAPA

Change control

Deviations/Non-compliance

Analytical Non-Compliance/OOS

Documentation (SOP, generic documents)

Training (staff qualifications)

Complaints

Supplier evaluation

Management of archive counter samples

Management of stability samples

Logbook

Quality Risk Management

Batch Record

Product Details

Controlled label printing

Safety Data Sheets

Events/Incidents

Work permits

Access Management/Periodic user review

Hardware Assignment

Hardware Inventory

Tasks planning

Purchase requests and budget approval

Employee card

Candidate Card

Schedule

Audit (internal/external)

Quality Area

The module supports and simplifies the management of internal and external audits, from planning, through execution, management of observations, with any related processes, follow-up, closure and final report. Integrates with Change, non-conformity, CAPA.


CAPA

Quality Area

The module supports CAPA management in all its phases. It assigns tasks directly from the system to the departments involved, monitors the progress of the process and any delays, organises and stores the documentation produced and attached to the system.


Change control

Quality Area

The module supports the management of change requests in all phases, from the request, through the evaluation of all departments involved (including the regulator if necessary), acceptance of the change, planning of the implementation, the CAPA (if necessary), until its complete closure.


Deviations/Non-compliance

Quality Area

The module supports the management of deviations, from the opening, to the execution and supervision of the investigation, to the assignment of tasks. It integrates with CAPA.


Analytical Non-Compliance/OOS

Quality Area

The module supports the input and investigation phase of OOS and OOT, guiding the user through the checklists and helping them throughout the process of identifying the cause and confirming or not the OOS.


Documentation (SOP, generic documents)

Quality Area

The module supports the management of any company document (SOP, forms, cards). It automates the process of creating, approving and formalising/obsolescing documents, also managing their subsequent revisions. The documents are always available in their official version to the corporate population. It integrates with the Training module/ Staff Qualifications.


Training (staff qualifications)

Quality Area

The module supports the management of qualifications and staff training. It allows you to create questionnaires, upload text, video and audio content, schedule retraining and send notifications around deadlines, and extract reports and dossiers, useful in case of inspections. It integrates with Documentation to support companies in the management of procedures requiring training.


Complaints

Quality Area

The module supports the QA step by step in the execution and supervision of Complaints from the market and to the supplier, allowing the user to manage (Complaint from the market) and keep under control (Complaint to the supplier) the investigation and cause finding phase. The dossier function to share information externally at the end of the process is very useful. It integrates with the CAPA process, which the user can open directly from Claims.


Supplier evaluation

Quality Area

The module enables suppliers to be assessed in order to keep them qualified over time, based on subsequent evaluations and assessments that allow them to be assigned Approved or Qualified status.


Management of archive counter samples

Quality Area

The module allows to manage the storage and collection of samples that are archived at the end of the production of a batch to support investigations related to complaints. It allows sampling to be carried out in a controlled manner and the disposal of any leftover samples to be managed at the end.


Management
of stability samples

Quality Area

The module allows you to define a plan for the stability analysis of the produced batches, detailing the samples available, the checkpoints at which the analysis should be carried out and also allowing you to record the results Withdrawals can be made in a controlled and registered manner. Finally, it allows the stability plan to be closed while also managing the disposal of any leftover samples.


Logbook

Quality Area

The module makes it possible to manage the logbook by completely eliminating the use of paper, allowing individual logbook records to be recorded electronically and ensuring that the logbook is finally reviewed.


Quality Risk Management

Quality Area

The module allows the management of QRM in all its phases, from risk identification to risk reduction, through an accurate assessment using the main tools such as FMEA, HACCP, HAZOP, etc.


Batch Record

Production and Supply Chain Area

The module supports the definition of master batch documents, production records and laboratory control charts associated with products. It automates the creation, approval and formalisation/obsolescence process and manages subsequent revisions; it also manages controlled printing of the document when it is to be used for production or analysis and allows variable data entry. Guarantees the control of first print and reprints and fast reconciliation in the batch record review phase by QA.


Product Details

Production and Supply Chain Area

the module enables the management of the introduction of a new product into a production site, allowing the definition of the production characteristics by the relevant departments (Master Data, Engineering, QC Micro, etc.)


Controlled label printing

Production and Supply Chain Area

The module allows you to define and approve the layout of the labels to be printed, containing the fixed information; once the layout is official, the controlled printing of the label (as many as needed) and the addition of variable data is possible.


Safety Data Sheets

EHS area

The module enables preliminary assessment of the hazardous characteristics of the materials used in the production of the products, after consulting the supplier's safety data sheet. It always guarantees the availability of the latest version. It also allows a layout of the labels that are printed, through other systems Pragma can interface with, for products that use hazardous materials.


Events/Incidents

EHS area

It allows the recording of any event that occurs in the company, specifying where, who, when and any witnesses, describing (any) immediate actions that are taken. It then allows an assessment to be carried out to identify the root cause, classify the event and understand any days of injury for those involved. It can be linked to CAPA to manage corrective and preventive actions.


Work permits

EHS area

It allows the risks linked to the types of work and the areas in which it is to be carried out to be defined in a special configuration area, and then to carry out an assessment in the event of dangerous work, establishing the place, date and persons involved (from which the above risks derive). It also defines a possible emergency team to intervene if required. The assessment results in a document to be provided to the contractors with the precautionary activities to be carried out before and after the work, which must be properly completed and signed. At the end of the work, a final assessment is conducted to give a final judgement on the work done.


Access Management/Periodic user review

IT area

Allows requests for access to company software systems to be made, allowing grants to be allocated, modified and revoked; it is also possible to carry out periodic reviews to ensure that access is only maintained for users who actually use it.


Assignment
Hardware

IT area

The module supports the management of allocation requests with: instant identification of required resources, allocation times and immediate verification of remaining availability.


Hardware Inventory

IT area

The module supports company inventory management to keep depreciation periods under control.


Tasks planning

Governance area

It makes it possible to create fully customised tasks in terms of their characteristics (time - work steps) and subsequently ensure their concurrent management in terms of planning, allocation, and work quality management.


Purchase requests and budget approval

Governance area

It allows the definition of expenditure budgets for different periods and cost centres. It considers the different expenditure items and ceilings for sub-periods and the management of purchase requests to be credited to defined budgets. Possibility to also define periodic requests with deadlines and renewals.


Employee card

Governance area

The module allows to have a complete and accurate personnel database and to extract all information related to specific skills and experience.


Candidate Card

Governance area

The module allows you to manage applications, classify job offers and helps you immediately identify the most suitable candidates.


Timetable

Governance area

The module allows us to identify the entities we want to monitor, define deadlines and receive automatic alerts on each deadline. Essential during inspection phases.


Drag and drop processes here

View added processes here

The processes only work with the PRAGMA 4U platform and cannot be purchased separately.

Are you interested in our processes or would you like to create your own?

Fill in the form or call us, one of our expertswill get back to you as soon as possible!

    I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)

    Are you interested in our processes or would you like to create your own?

    Fill in the form or call us, one of our expertswill get back to you as soon as possible!

    Address
    V.le PL Nervi,
    Latinafiori Tower 4,
    04100, Latina

    Telephone
    + 39 0773 694245

    Fax
    +39 0773 417509