Quality and Certifications

This is the philosophy of SPAIQ S.r.l. (hereinafter also referred to as SPAIQ): to provide useful tools for the verification, dissemination, maintenance and archiving of information that is produced during the design and testing of automation systems.

SPAIQ has been active for over 20 years in:

• the packaging industry;
• the industry that manufactures the drugs and ancillary utilities;
• the pharmaceutical industry
• technical documentation

Its mission is to protect the health of the end user. An in-depth understanding of processes, risks and thorough testing ensures real protection of human and animal health.

Therefore, authorization for the production and packaging of drugs is only granted to pharmaceutical companies when they demonstrate that their processes comply with GMP (Good Manufacturing Practices) procedures.

This can only be achieved through accurate and precise validation, rigorously documented at all stages.

SPAIQ accompanies pharmaceutical and packaging companies in the validation of machines, carefully assessing risks and preparing the necessary documentation.

Validation is a very delicate process, concerning anything that may pose a danger to the person or animal that will use the drug once it is placed on the market or in the healthcare system. Validation of machines follows their life cycle.

In the contractual phase, the user (the pharmaceutical company) prepares the URS (User Requirement Specification) document in which it lists its requirements in terms of quality, production, safety and maintenance. Whereas the machine manufacturer must specify how he intends to meet the user’s requirements.

All parts of the system that affect quality and product safety must be explained in detail in the Validation. Careful assessment must be made of the risks that are expected to remain in spite of established actions or deliberately accepted for any possible pharmaceutical defect.

In this respect, SPAIQ also supports the customer in the selection and construction of the most suitable validation strategy. It therefore provides high-level consultancy using a compendium of experience acquired over more than 20 years of established methodologies in the field of risk analysis.

SPAIQ also carries out the testing and qualification of machines by qualified and continuously trained personnel.

To implement such sensitive services, SPAIQ relies on certain guiding values that define the identity of its corporate culture:

• pursuit of excellence: industry regulations and, at the same time, the technological development of machines are constantly evolving. SPAIQ aims to constantly offer a high-quality service that strives for excellence, aware that the values of the patient’s health and well-being are and always will be a priority;
• customer satisfaction: SPAIQ aims at customer satisfaction and the company’s presence in the market for more than twenty years testifies that this is a top priority;
• innovation: SPAIQ believes in technology and has created validation software that enables more accurate risk analysis, minimizing the possibility of errors;
• employees and experience at the heart of the project: many of SPAIQ’s employees have been with the company since the year it was founded, thus providing the new, young and dynamic staff with their experience, which is essential in what is certainly a complex sector;
• training to broaden cognitive horizons: all SPAIQ personnel are continuously trained not only on quality but also on specific industry regulations that are constantly evolving;
• for pharmaceutical companies and the packaging industry attention to detail in documentation and care during testing: this is the only way to guarantee a high-quality service;
• health is a non-negotiable value: we know that SPAIQ’s work affects the health of humans and animals. Health is a non-negotiable value, so the company is proud of what it does, but feels strongly the weight of responsibility;
• responsibility: SPAIQ believes that quality is only achieved if every resource is empowered in the processes they perform. Try to do this every day with utmost dedication;
• individuals count, but above all the project: all SPAIQ staff are aware that they are part of a higher-value project, helping companies in such delicate processes as consulting, validation and testing. It is, therefore, uncompromisingly committed;
• pursues continual improvement because it knows that this is the only way to govern complexity. Every day it improves its performance or tries to do so, a little or a lot, to govern complexity in areas, those of validation and testing, which are delicate and risky.

The company knows that improving processes (and the quality management system) is what enables it to create value for customers, end users and people.

SPAIQ is based in Villanova di Castenaso, in the centre of Italy’s Packaging Valley.