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Machine producers has always invested in research and development: the companys has at its disposal a staff of specialized technicians and engineers with long experience and in-depth, up-to-date knowledge in the field of packaging machines who are involved in the creation of highly advanced technological machines.
The entire teams can provide its clients with immediate, up-to-date solutions that are also the result of continuous collaboration with the engineers and management of leading multinational companies.
Both the electronic and the mechanical departments are involved in finding new solutions to ensure machines with the latest technologies. They constantly perform metrological tests to ensure that our equipment complies with international standards that govern the food and other industries, expecialy for farmacology, cosmetic industry..
Instructed for use and maintenance
The instruction manual provides all necessary information on:
A unique, specific manual is created for each machine. It deals with its specific operation, and includes the serial number and customer identification. This makes it a custom-made document that is specific for each produced machine, and which makes its operation and maintenance easier.
The manual consists of a general part with information on use of the machine. It then goes into greater detail concerning technical features, the method for installing, starting and shutting down the machine, operating modes, the adjustment of various functions, replacements and adjustments, and cleaning and maintenance.
Protocol Validation
Along with the documentation needed for use, operation and maintenance that comes with every machine, the client can request a Protocol Validation in accordance with the standards GMP and GAMP 4 or GAMP 5 Summary. This documentation provides the highest guarantee that a specific process generates a product with the pre-defined specifications and its quality attributes.
The IQ OQ validation documents and controls, by means of the Protocol of Validation, the functions, features, and operation of the specific machine.
The Protocol of Validation is prepared based on the provisions of the standards GMP (Good Manufacturing Practice) and GAMP 4 or GAMP 5 Summary(Good Automated Manufacturing Practice) created for and used by the pharmaceutical sector.
A team of skilled technicians deals with all the forms for the testing the system is to undergo and the preparation of documents such as FS, DS, IQ/OQ Test Protocol.
21 CFR PART 211 OF THE FDA (documentation security)
Principals, which also works in the pharmaceutical and food sectors, has always given the utmost attention to issues such as quality, tracking of data and care for instrumentation that is used. This commitment is driven by the innate skill and professionalism that characterize the company, and recently by the need to meet the validation requirements of the FOOD AND DRUG ADMINISTRATION (FDA).
The FDA validates each production process and required documentation evidence that any food or drug product has followed a proper production process, in accordance with the various phases established by international standards and established norms.
The document 21 CFR part 211 specifically analyzes documentation security and requires companies that produce drugs for human use to follow certain guidelines concerning identification, tracking and authentication of documents concerning the development and production of those drugs.
The FDA requires constant filing of documents during the production phase. These documents may be inspected at any time.
The document 21 CFR part 211 therefore establishes the guidelines to be followed so that any system is able to provide the documentation and electronic signatures to ensure the possibility to verify and validate those documents, for the recognition of the operator and the printing of production documents.
Processing of personal data is any process or set of procedures performed on personal data, whether automated or non-automated, such as collecting, recording, organizing, structuring, storing, adapting or modifying, finding, inspecting, using, detecting, transmitting, disseminating or posting otherwise available, harmonizing or combining, restricting, deleting or destroying.
The policy applies to all services of DORA-PAK d.o.o. which include personal data processing activities in which DORA-PAK d.o.o. controller in the sense of the General Data Protection Regulation (Regulation of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data available at: http://data.europa.eu/eli / reg / 2016/679 / oj
