Task, View and Values

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2 Task, View and Values TASK VIEW VALUES We help to analyze, improve and validate the key business processes of our clients, through our own methodology, so we can guarantee the quality, the efficiency and the integrity of the information. We aim to be a national reference for the validation of key business processes in industrial environments, with the aim of extracting the maximum potential and profitability in a technological environment. We listen, we have enthusiasm and initiative, we work as a team, we innovate constantly and we fulfill our commitments from a position of transparency and honesty.

3 About us We are experts in computerizing critical business processes and validating computerized systems in regulated environments. We work with companies with a vocation of leadership and a desire to improve, making a real impact on company profit. As a result of more than 10 years of professional experience in the Pharmaceutical, Cosmetic and Food industries, we have developed a unique and proven methodology that we make available to leading industrial companies to help and support them in achieving tangible results. In this way companies can improve and validate their critical business processes. Our service approach is based on our commitment to our customers to achieve real cost effectiveness in the investment that they make in projects of industrialization, computerization and technological innovation. We help your business processes to be more robust, reliable and efficient. Our team has the qualification, experience and motivation to get excellent results forming teams that work closely with our clients. We work together to share the unique vision to make a real impact on your business.

4 Services BUSINESS PROCESSES COMPUTERIZATION OF PROCESSES COMPUTER SYSTEMS VALIDATION VALIDATED ENVIRONMENT MAINTENANCE Purchasing Manufacturing Internal Logistics R&D External logistic Sales Quality ERP SGA LIMS MES SCADA KPI s Strategy Training Validation Controlled withdrawal (in the case that it has to be Validated Environment Maintenance COMPUTERIZATION OF PROCESSES COMPUTER SYSTEMS VALIDATION (GXP) Needs analysis Process of selection of technological suppliers and computerized systems Accompaniment in the implementation and maintenance of technological solutions Validation of ERP, SGA, LIMS,MES, SCADA Training Internal audits Audits of technology suppliers

5 Service Bases From the knowledge of the initial situation and the causes that bring about change, we design the strategy to achieve the objectives. We have the points of view of all areas of the company in order to control all the risk factors. We fulfill the premise that the computerization of a process should not be to the detriment of the quality of the product, control of the process or quality assurance. We promote solutions that act as a guide in the process, provide controls, security and valuable information to organizations for better decision-making. We ensure the proper operation of the system, training of users, the correct communication with the equipment and technological suppliers involved in the process according to the established objectives. We define protocols for the maintenance of the solutions implemented during their life cycle.

6 Computerization of processes in regulated environments (IFS, GxP, FDA) The optimization of processes through the implementation of computerized systems is a fact (industry 4.0). A computerized system ensures the fulfillment of the process designed by the organization and it can act as a guiding tool in the execution of tasks, adding the controls and indications that are necessary at each moment. These systems therefore ensure the process, as well as being a source of data on the situation of the company and the factors that can affect the safety and quality of its processes and products. In this way, it is possible to implement a control system composed of indicators and objectives that allow, from the knowledge of the situation, quality assurance, optimization processes and reduction of waste. OQOTECH supports its clients in the process of selection, implementation and maintenance of computerized solutions that are appropriate for their requirements and processes. DESIGN MANUFACTURING LOGISTICS PROCESS CONTROL DATA EXTRACTION INFORMATION GENERATION DECISION MAKING PREDICTIVE MODEL

7 Process computerization in regulated environments (IFS, GxP, FDA) User requirements Market. Search for existing s olutions Service supplier Implantation of the solution in the company Maintenance Analysis of user requi- Search for computeri- Assurance of service, IImplantation of the Maintenance of compu- rements in business zed systems in the agreements with the computerized system terized systems in the processes to be compu- market which satisfy supplier. From different in the company, chec- company, defining terized. This means the requirements and types: licensing, service, king configuration to follow-up protocols and elaborating a list of needs your service supplier. We support and maintenan- adapt it as much as management of improve- which can be of technolo- carry out a process of ce. possible to the processes ments. gical, computer, functio- selection after looking at of the company, docu- nal or regulatory type. the options that exist in mentation of the configu- the market with the aim ration, operation and of being as standard as safety, training for users possible. and recording data generated: traceability.

8 Computer Systems Validation in regulated environments (GxP, FDA) In environments that are regulated or whose degree of computerization is high or critical it is vital to establish a working methodology to ensure the correct operation and management of the computerized system over time. In OQOTECH we accompany you in the validation process of the computerized systems that are critical to your organization, establishing an optimized work methodology, based on the identification of risks of the computerized process. Information Integrity Service Suppliers Computerized Systems Assurance of the COMPUTERIZED PROCESS End Users Computing Infrastructure

9 Computer Systems Validation in regulated environments (GxP) Strategy Qualification Computer Infrastructure Computer Systems Validation Maintenance Withdrawal Development of valida- Another determining The foundation principle In order to keep the The withdrawal of a tion plans and qualification of the infrastructure that determines the strategy to follow in the validation. Determine which computer systems and processes are affected, the tasks to be developed in the project, the staff factor that needs to be ensured is the computer infrastructure, by which the software can work properly, so that it has all the resources that it needs for its proper working and can access and record the to ensure in any computerized process is the applications that manage the critical processes of the company. This applies throughout the system life cycle. It appears with the need to computerize a environment validated permanently, it is necessary to determine the procedures that will be implemented in the organization. These procedures should reflect the activities to be carried out, computerized system must be carried out in a planned way, the following critical points must be managed: storage of critical data, the required archive time, data migration management and involved and their responsibilities, objectives, acceptance criteria and planning time. information obtained from the processes, in a reliable and optimal environment. process, through its definition, development, testing, documentation, user training, implementation time of execution and periodicity, scheduled reviews, as well as determining the responsible management with the service supplier and release for use. people.

10 Organizations and Regulations Organizations: European Medicines Agency (EMA) Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Food and Drug Administration (FDA) International Conference on Harmonisation (ICH) International Society for Pharmaceutical Engineering (ISPE) Pharmaceutical Inspection Co-operation Scheme (PIC/S) International featured standards (IFS) Regulations and Guidelines: EU GMP, EU GDP, GLP 21 CFR Part 11 GAMP 5 ITIL

11 Development Center Calle Capellà Belloch, Alcoy Alicante Valencia Office Plaza Conde de Carlet, Valencia Madrid Office Calle Príncipe de Vergara, Madrid info@oqotech.com