With greater usage of computerized systems across all fields of regulated companies, technological advances, as well as greater importance given to inspection of regulatory organisms and clients about the system, it is necessary for a greater effort to authenticate and maintain the status of the systems in accordance with current standards and regulations.
Qualipharma is your ideal partner to support you every step of the way in the life of these systems, and their authentication in accordance with the regulations, guides, and norms. Integrating services from timely support to the complete development of your IT quality system.
Qualipharma CSV has a dedicated team of professionals, experienced in system authentications in line with GxP found in companies:
- Enterprise Resource Planning (ERP)
- Document or Content Management System (EDMS/EDMS)
- Laboratory Information Management System (LIMS)
- Laboratory Data Treatment System
- Manufacturing Execution Systems (MES)
- Electronic Batch Recording (EBR)
- Control, monitoring and registration systems (SCADA, HMI, DCS, etc.)
- Maintenance management systems
- Pharmacovigilance systems
Developing projects in accordance with the requirements of different regulatory agencies (EMEA, FDA, MHRA, ANVISA, CADTH, etc.), guides, and standards (ISPE GAMP 5, ASTM 2500, etc.) based on risk management tools, necessary to identify potential risks and rationalize the effort of authentication. Qualipharma has the ability and the know-how needed to support your projects through managing them: defining development strategies, implementation, putting into practice, authentication, etc., or through the development of ad hoc support activities. The Qualipharma CSV team also has the solutions and the experience to support developers and implementers with solutions or systems for regulated environments, helping regulatory compliance and bring strategies and ideas for the development of the life cycle (SDLC), the improvement or implementation of required quality systems, of verification processes during the development and authentication of the system: resulting in greater client confidence and less authentication stress.
- Highly experienced team and established in the sector with many successful cases under their belts in all fields of the company
- Ability to integrate into your work team, policies, procedures and methodology
- Ability to rationalize the effort and cost of authentication projects
- Integration from the start of the project bringing a regulatory vision from the planning and definition of the system
- Knowledge of the latest trends and technologies