Developing a computerized system based on an appropriate quality system and also on the sector regulations and standards, will help to booting up potential client’s confidence and will reduce the effort while implementing it.
Nowadays, most of the companies demand to implement a system developed on these basics, following the system life cycle as a way to reduce to a minimum the risk of errors. Therefore, every system developer who want to offer his services to the pharmaceutical, healthcare, food or biotechnology sectors, among others, must be familiar with terms such as EU GMP Annex 11, 21 CFR Part 11, GAMP 5, AST2500, etc.
The quality systems implementation and the computerized system development, should not be considered as a requirement but as a unique commercial opportunity for strengthening the business and to reach the largest audience possible. Qualipharma is your ideal ally to give you comprehensive support on the computerized system development and implementation.
Computerized systems designed for been used in regulated sectors and industries, most be developed and implemented according to the policies and procedures of quality systems. Some of the most important stages are:
- Development of functional specifications that describe properly the system functionality and meet client’s requirements.
- Development of design specification at every stage, including Hardware, Software, Unit Modules, etc. to facilitate technical solutions for the development of the system functionality.
- Code verification.
- System verification at every stage: units, modules, modules integrity, etc.
- Relationship with suppliers.
- Control of systems version.
- Control of changes during the computerized system development and implementation.
- Development of support and consulting materials such as manuals, set up guides, technical requirements, etc.
- Factory Acceptance Tests (FAT).
- System Acceptance Tests (SAT).
- System user´s training.
Qualipharma CSV has a team of professionals with a great technical background and experience on computerized system. We can support you on every phase of your system development and implementation, to make sure it accomplishes the standards and applicable regulations.
- Team of professionals with a great technical background and experience on computerized system and with uncountable successful cases on the sector
- Team eager to embrace change and continuous improvement, able to join your work team and to work following your company policies, procedures and methodologies
- Deep knowledge about the latest trends and technologies available
- Rationalization of the effort and system´s implementation costs
- Team integrated and fully committed since the very first stage of the project