Consultant Certified Professional Medical Software (GxP)

WorkinWith supports its customers in the pharmaceutical and food industries by implementing and proposing a set of solutions in terms of IT security and risks related to their activity. Our consultants carry out risk analysis in order to reduce risks, optimize the organization and guarantee security.

WorkinWith’s clients must examine all phases of the life cycle of a medical or life sciences product and, for each activity, consider the risks that could arise from the compromise of confidentiality, availability or integrity of the information or information technology.

Our consultants assist and support them in optimizing these solutions in terms of security and risk management related to their activity.

The expertise of our Certified Professional Medical Software (CPMS) consultants is based on these main areas:

• It is responsible for the validation documentation (IQ, OQ), as well as the continuous updates of the documents, in coordination with the development teams. This documentation must be an accurate reflection of the client’s activity. 
• Our consultants ensure the creation of validation and qualification documents in coordination with the functional departments and quality assurance (QA)
• They are also responsible for the qualification and validation of internal tools. For example: CI Server or version control system
• A precise methodology that allows for traceability in order to reconstruct the history of production in a rigorous manner
• The implementation of an accountability system that allows to determine, in time, each contribution to the development (to optimize the security of their activity)
• Knowledge of and respect for the standards of these sectors

Our Certified Professional Medical Software CPMS consultants establish, implement, document and maintain a quality system. They are in charge of the existing validation strategy in coordination with the WorkinWith customer teams in order to minimize the effort on the customer side during the ERP implementation, and to optimize the efficiency and speed of the system and the internal processes. They leverage the Microsoft component layer to deliver solutions that meet customer needs.

Our WorkinWith clients are supported in their growth with GxP solutions on Azure and Office 365 that can leverage the benefits of the Cloud while protecting the security of the consumers (they provide); product quality and data integrity and secure. In this way, the consultant ensures that their client and their client’s consumers benefit from multiple layers of security and governance technologies, operational practices, and compliance strategies that strengthen data privacy and integrity at specific levels