Client: a company that has always been involved in the research, development and marketing of innovative drugs.
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.
In view of continual improvement and compliance with sector regulations and internal procedures, the Client saw the need to develop and validate an HPLC analytical method for the determination of residual solvents in gaseous emissions in non-confined environments.
The S4BT Consultants took care of both the analytical part, (including the development of the method and the execution of all the analytical tests), and the documentary part, including the writing of the protocols and the related report.
The following requirementswere verified for the development:
The analytical method developed and validated has fully satisfied all the parameters established by the client and those required by the reference standards. The method 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