Portfolio

Marcin
Marcin
Senior Lead and Team Validation

Validation of Systems in the AWS and SAP Cloud

IT system validation is primarily Critical Thinking and Risk Based Approach. The key is to identify and assess project risks and minimize their impact on the “system intended use”, patient safety and data integrity.

In order to provide the client with a solution that meets his expectations, we must flexibly plan the validation, required products and supporting tools. An experienced Project Manager and Validation Specialist will be indispensable. These are the foundations of effective system support in the operational phase.

The IT system is also its specifications, risk matrix, tests and reports that must be prepared in a smart manner, so that they are undisputed proof of validation for the auditor and, at the same time, material for the work of the project team.

Therefore, in our everyday projects, Computerized System Validation is increasingly evolving towards Computerized System Assurance, and Documentation Management towards Records Management.

Andrzej
Andrzej
Senior Validation-Qualification Manager

GMP Qualification and Validation

I deal with GMP audit, qualification of suppliers of active substances, immediate packaging and validation of computer systems. I have validated equipment and processes in the past. The scope of my experience and interests also includes audits of laboratories and contract manufacturers.

I carried out full GMP audits from the quality side and audits of ISO requirements. My activities mainly concern the pharmaceutical industry, as well as food and cosmetic companies. I was hired to pinpoint optimal solutions prior to inspections. I was getting great feedback then!

I also deal with the rescaling of biotechnological processes.

Mateusz
Mateusz
Senior Validation-Qualification Manager

Validation Processes for Solid Forms of Medicinal Products

I supervised the quality and verified the validation and qualification processes during the production of solid forms of medicinal products. I participated in various activities, starting with planning and initiating validation and qualification processes that are subject to a formal change control process, and ending with participation in tests and approval of a complete set of documentation.

Piotr
Piotr
COO Quality

Digital Upgrade Option Program

With a 30-person management team and subcontractors, we completed the scope of tasks for the Digital Upgrade Option Program. Our goal was to build and implement an effective management process for the distribution and implementation of digital product keys during the scaled motherboard production cycle of global electronics manufacturers. The scope of tasks included, among others:

  • Qualitative three-dimensional feasibility analysis (3Q): efficiency and scalability; compliance with current and future standards; process safety.
  • Building a dedicated system based on Microsoft Dynamics Axapta and group of necessary modules for integrated systems and applications, including dedicated applications and embedded systems.
  • Creation and allocation (hybrid – in Azure) of a dedicated Data Center.
  • Development of documentation and implementation of processes compliant with, inter alia, Uptime Institute: Security/Design/Facility/Operations; ISO; GxP, ITIL GDPR.
  • Establishing a permanent team for the management, development and maintenance of the Digital Upgrade Option Program.

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