The package optimises Quality Control activities. It includes 3 processes: Management of archive counter samples, Management of stability samples, Laboratory logbook.
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.
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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!
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!
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