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QA
Quality Department
This package streamlines Quality Control activities. It includes three processes: management of archived reference samples, stability sample management, and laboratory logbooks.
This package streamlines quality control activities. It includes three processes: Management of archived reference samples, Management of stability samples, and Laboratory logbook.
Build your own package by selecting the processes that best fit your needs.
Audits (internal/external)
CAPA
Change Control
Deviations/Nonconformities
Analytical Nonconformity/OOS
Documentation (SOPs, General Documents)
Training (Staff Qualifications)
Complaints
Supplier Evaluation
Management of Archive Counter-Samples
Stability Sample Management
Logbook
Batch Record
Product Sheet
Controlled Label Printing
Safety Data Sheets
Events/Incidents
Work Permits
Access Management/Periodic User Review
Hardware Allocation
Hardware Inventory
Task Planning
Purchase Requests and Budget Approval
Employee Profile
Candidate Profile
Schedule
Audits (internal/external)
Quality Department
The module supports and streamlines the management of internal and external audits, from planning through execution and the handling of findings—including any related processes, follow-ups, closure, and final reporting. It integrates with Change, Nonconformities, and CAPA.
CAPA
Quality Department
The module supports CAPA management throughout all its phases. It assigns tasks directly from the system to the departments involved, monitors the progress of the process and any delays, and organizes and stores the documentation generated and attached to the system.
Change Control
Quality Department
The module supports the management of change requests at every stage, from the initial request through evaluation by all involved departments (including the regulatory department, if applicable), acceptance of the change, implementation planning, CAPA (if necessary), all the way to its complete closure.
Deviations/Nonconformities
Quality Department
The module supports the management of deviations, from opening a case to conducting and supervising the investigation, and assigning tasks. It integrates with CAPA.
Analytical Nonconformity/OOS
Quality Department
The module provides support during the data entry and investigation phases for OOS and OOT, guiding the user through the data entry process using checklists and assisting them throughout the entire process of identifying the cause and confirming or ruling out the OOS.
Documentation (SOPs, general documents)
Quality Department
The module supports the management of any company document (SOPs, forms, data sheets). It automates the process of creating, approving, and formalizing or decommissioning documents, while also managing subsequent revisions. The official versions of documents are always available to all employees. It integrates with the Training/Staff Qualifications module.
Training (Staff Qualifications)
Quality Department
The module supports the management of employee qualifications and training. It allows you to create questionnaires, upload text, video, and audio content, schedule retraining, send notifications as deadlines approach, and generate reports and dossiers, which are useful in the event of inspections. It integrates with the Documentation module to help companies manage procedures that require training.
Complaints
Quality Department
The module provides step-by-step support for QA in handling and supervising complaints—from the market to the supplier—allowing users to manage (market complaints) and monitor (supplier complaints) the investigation and root cause analysis phases. The dossier feature is very useful for sharing information externally once the process is complete. It integrates with the CAPA process, which the user can initiate directly from the Complaints module.
Supplier Evaluation
Quality Department
This module allows you to evaluate suppliers in order to ensure they remain qualified over time, based on subsequent evaluations and assessments that determine whether they are designated as “Approved” or “Qualified.”
Management of Archive Control Samples
Quality Department
This module allows you to manage the storage and sampling of samples that are archived at the end of a batch’s production to support investigations related to complaints. It enables you to collect samples in a controlled manner and, at the end of the process, manage the disposal of any remaining samples.
, and Stability Sample Management
Quality Department
The module allows you to define a plan for stability testing of produced lots, specifying in detail the available samples and the checkpoints at which the tests must be performed, and also enabling you to record the results. Samples can be collected in a controlled and documented manner. Finally, it allows you to close out the stability plan while also managing the disposal of any remaining samples.
Logbook
Quality Department
This module allows you to manage the logbook entirely without using paper, enabling you to electronically record individual logbook entries and ensuring their final review.
Batch Record
Production and Supply Chain Division
The module assists in defining production master batch records and laboratory control charts associated with products. It automates the process of creating, approving, and formalizing or decommissioning these documents, and manages subsequent revisions; it also manages the controlled printing of the document when it is needed for production or analysis and allows for the entry of variable data. It ensures control over the first print and reprints and enables rapid reconciliation during the batch record review phase by QA.
Product Sheet
Production and Supply Chain Division
The module enables the management of a new product's introduction at a production site, allowing the relevant departments (Master Data, Engineering, QC Micro, etc.) to define the production specifications.
Controlled Label Printing
Production and Supply Chain Division
This module allows you to define and approve the layout of the labels to be printed, which contain fixed information; once the layout is finalized, you can print the labels as needed and add variable data.
Safety Data Sheets
EHS Department
The module allows for a preliminary assessment of the hazard characteristics of the materials used in the manufacture of products, following consultation of the supplier’s safety data sheet. It ensures that the latest version is always available. It also provides a layout of the labels to be printed—via other systems with which Pragma can be integrated—for products that contain hazardous materials.
Events/Incidents
EHS Department
It allows you to record any incident that occurs at the company, specifying where, who, when, and any witnesses, and describing any immediate actions taken. It then allows you to conduct an assessment to identify the root cause, classify the incident, and determine any lost-time days for the individuals involved. It can be linked to CAPA to manage corrective and preventive actions.
Work Permits
EHS Department
It allows you to define, in a dedicated configuration area, the risks associated with different types of work and the areas where the work is to be performed, and then to conduct an assessment in the case of hazardous work, specifying the location, date, and individuals involved (from whom the aforementioned risks arise). It also designates an emergency response team, if necessary, to intervene when required. The assessment results in a document that must be provided to the workers performing the tasks, outlining the precautionary measures to be taken before and after the work; this document must be properly completed and signed. Upon completion of the work, a final assessment is conducted to provide a definitive evaluation of the work performed.
Access Management/Periodic User Review
IT Department
It allows you to submit requests for access to the company's software systems, enabling the assignment, modification, and revocation of access grants; it is also possible to conduct periodic reviews to ensure that access is maintained only for users who actually use it.
, Hardware Award
IT Department
The module assists in managing assignment requests by: instantly identifying the necessary resources, determining assignment timelines, and immediately verifying remaining availability.
Hardware Inventory
IT Department
The module assists with managing company inventory to keep track of depreciation periods.
Task Planning
Governance Area
It allows you to create fully customized tasks in terms of their characteristics (time, work steps) and subsequently ensure their coordinated management in terms of scheduling, assignment, and quality control.
Purchase Requests and Budget Approval
Governance Area
It allows you to set spending budgets for different periods and cost centers. It takes into account various expense items and spending limits for sub-periods, as well as the management of purchase requests to be charged to defined budgets. You can also set up recurring requests with due dates and renewals.
Employee Profile
Governance Area
This module provides a comprehensive and up-to-date personnel database and allows you to retrieve all information related to specific skills and experience.
Candidate Profile
Governance Area
This module allows you to manage applications, categorize job openings, and helps you immediately identify the most suitable candidates.
Schedule
Governance Area
This module allows you to identify the entities you want to monitor, set due dates, and receive automatic alerts whenever a due date is reached. It is essential during the inspection phase.
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These processes are available only within the PRAGMA4U® platform and cannot be purchased separately.
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