We have been on the market for over 25 years, offering consulting services in the areas of quality, project management, validations, and qualifications in the Life Science sector.
We provide bespoke services in Time and Material, Project Consulting, Service.
We are UNI EN ISO 9001: 2015 certified, and we operate a rigorous quality system aimed at respecting the high standards of the sector in which we operate.
We invest in individual expertise. Our consultants followa structured course of continuous training. Since 2017 we have dedicated over 7000 hours to training.
We have an internal network of transversal skills to offer complete, high quality services.
Our consultants are guided by experienced and certified PMs who design the best strategy to achieve the client's objectives.
We operate with flexibility, adapting to schedules and locations to meet the needs of our clients. We have the technology to work both remotely and from client offices with ease.
Acquisition of specific expertise, management of demand peaks, temporary increase in production capacity, use of internal resources on value-added activities.
We analyse needs and together identify the service and individuals most suited to meeting our client’s requirements.
With a structured and reactive process which places the client at the centre, we are able to quickly provide the best resources to achieve business goals together.
With Time and Material Consulting, the choice is yours. With a structure that is strongly focused on service delivery, you decide on the professional profile and for how long you will need it. We know how to integrate perfectly with your team based on what is shared with the business representatives.
Project consulting involves the assignment of specific projects defined over time, during which we accompany you to the outcome through careful analysis, planning, and control in all project phases.
Customised outsourcing service for Process, Packaging & Cleaning Validation, Equipment and Facilities Qualification, Computer System Validation, and Quality activities able to fully cover the needs of companies in the Life Science sector.
Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.
The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.
PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.
During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes
It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.
The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.
PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.
Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes