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Contec – Technical documentation

Producing technical documentation calls for time and resources which are not always considered productive, after a product has been successfully launched.
CONTEC plays the role of technical offices at this delicate stage, where precision, order and competence are necessary. With the aid of the latest software tools, the documentation sector drafts wiring lay-outs, lists, installation and cable routing lay-outs to CEI standards, both for projects to be developed, and to document existing systems.
On top of that, to pinpoint products characteristics and to facilitate maintenance jobs, we can rapidly supply detailed easy-to-understand manuals, prepared according to formats and styles defined by the customer.

In pursuit of its policy of innovation and of sharing the user’s requirements, CONTEC has specialised in supplying more specific documents, known as validation documents. These documents officially accompany the execution of acceptance tests when the automatic systems are delivered, and provide objective evidence of the typical stages of their life cycle. By using the sector’s GAMP guidelines as a reference, the persons in charge of technical documentation are thus the end-customer’s true consultants.
Risk analysis is the means for dealing rationally and systematically with the main problems linked to the development and production of a pharmaceutical product.
All the chief guidelines mention it, although, in actual fact, the available literature on the subject describes – but only in a general manner – the possible application techniques.
Risk analysis is normally performed by the customer’s team. The team examines the different stages of the production process with the aim of identifying and defining factors which have a significant effect on the quality of the product and on its safety (code check, printing of variable data, presence of leaflet in the carton, etc…).
The result of this analysis determines the most appropriate precautions to safeguard the quality of the final product and will be kept under consideration for the entire life-cycle involved in producing a pharmaceutical product: starting from the design of the systems, their construction, qualification and validation, through to planning the controls and set-up of the SOP (Standard Operating Procedures).

The document drafted by CONTEC allows the customer’s team to evaluate at even greater depth. This is possible thanks to the participation of technicians with long experience of production logic, able to examine the systems’ plans in order to verify the absence of non-considered critical points.
The bodies verifying pharmaceutical and non pharmaceutical companies are increasingly studying the methods for verifying the adequacy of the control systems implemented by the pharmaceutical companies, in order to guarantee the conformity of their products. Therefore, in-depth risk analysis is a must.