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Client: an important chemical-pharmaceutical multinational engaged in the development of new drugs, the introduction of cutting-edge technologies and innovative health management practices.
Sector: chemical-pharmaceutical
Objective: to develop and validate an HPLC analytical method for the determination of residual solvents in gaseous emissions in non-confined environments.
The client company is a leading international chemical-pharmaceutical producer, engaged for decades in the development of new drugs, the introduction of cutting-edge technologies and innovative health management practices.
The Client needed to develop and validate an HPLC analytical method for the determination of residual solvents in gaseous emissions in non-confined environments. For this activity, the Client relied the skills of the S4BT Lab Consultants, who took care of both the analytical part of the project (development of the method and execution of all analytical tests), and of the documentary part, including the writing of the protocols and the related report.
The Client relied the skills of the S4BT Lab Consultants, who took care of both the analytical part of the project (development of the method and execution of all analytical tests), and of the documentary part, including the writing of the protocols and the related report.
The following requirements were verified for the development:
The analytical method developed and validated fully met all the parameters established by the client and those required by the reference standards, and is still used successfully by the pharmaceutical company.
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