Projects and documentation created by S.I.A. comply with the GAMP guidelines and international standards for the pharmaceutical industry. This has been confirmed many times by positive results obtained during the inspection of independent audit institutions.
Our quality policy is based on four fundamental pillars:
The right to choose contractors that offer the highest quality of services
Limiting the scope of services to the pharmaceutical industry has allowed us to acquire expert knowledge in this field and constantly increase our knowledge and know-how. Term “pharmaceutical” is very often synonymous with the most complex and restrictive standards. Of course, it is not a problem for us to adapt systems for areas with lower requirements.
A high level of competence of technical staff covering a wide range of issues
Our employees go through a very thorough training, not only focusing on expanding knowledge of programming methods, but also in areas related to standards and regulations, production processes, machines and technologies typical for the pharmaceutical and food industry. Each completed training is completed with a competence test and recorded in the employee’s training records.
Areas of competence:
- The general mechanism of action of drugs depending on the route of administration.
- Microbiology, chemical-physical processes and hygiene as fundamental factors affecting the conception, functioning, procreation and elimination of microorganisms.
- The most common methods of sterilization: filtration (gas and liquid), by heat (wet or dry), by radiation (g and UV), by chemical agents (ethylene oxide), disinfection, sanitary hygiene, pasteurization.Production processes of solutions for injections, solids (powders, lyophilizations, tablets and capsules), creams (ointments, pomades, lotions), oral fluids and sprays.
- Water purification and air treatment for pharmaceutical use.
- Machines for sterilization (autoclaves, tunnels, stoves).
- Basic GMP principles based on a set of standards used in the pharmaceutical and food industry, e.g. production processes and storage environments, pharmaceutical solutions, computerized control systems.
- Standards and regulations used in the pharmaceutical industry (GxP, GAMP).
- Interpretation and application of audit trail of data records and electronic signatures according to FDA regulations of 21 CFR part 11.
A full set of procedures in accordance to the pharmaceutical standards
Despite the small size S.I.A. has a full set of procedures defining the life cycle of a system from the project start-up meting to post-implementation support. The procedures are based on GAMP principles, GxP requirements for the pharmaceutical industry while keeping in mind common sense and practical use of the application.
Our staff is well-trained in these procedures and follow them with conviction and we are well aware that this is one of the points that distinguishes us from other companies in the sector. This approach allows for well-documented and standardized system implementation that are understandable even after a longer period of time (of course any necessary modifications can be made) by the user with the appropriate technical knowledge, or an employee of S.I.A. If necessary, our specialists are ready to provide technical support to new and regular clients during production, validation, change or improvement of systems.
Excessive system tests before delivering them to the customer.
All created systems are thoroughly verified by S.I.A. before installation even when it is not required by the customer. The only difference in this case is that the verification is not documented.
If the requirements presented by the customer are unambiguous and complete, and also during the process of system development the scope of work is not modified, this method allows to shorten the time of implementation of the system at the customer site to the installation and commissioning.