Validation according to GMP Systems

In relation to certain industries, such as the Pharmaceutical, Blulink has experience for the validation of systems, especially with regard to the contexts related to the regulatory agencies such as the FDA (Food and Drug Administration), the EMA (European Medicines Agency), the PIC/S (Pharmaceutical Inspection Convention). The rules, which cover the entire lifecycle of the drug development from GLP (Good Laboratory Practice), the Clinical Research GCP (Good Clinical Practice), the Registration Regulatory Submission at Production (Good Manufacturing Practice), the GDP distribution (Good Distribution Practice), are very stringent in expressing a basic concept: In these cases, it is assummed that everything that was not documented was not done!

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Overview

Among the critical success factors for the use of a software system , which is relevant from the point of view of GxP and therefore should best meet the current regulatory requirements, is the availability of a well-structured documentation for its validation. Blulink has developed a complete set of documents with the aim of describing their systems and to provide its customers with the tools needed to accomplish the verification of their correct operation. This documentation is structured to be ready for use.The critical functionality and acceptance testing of the system are fully covered by the system . The presence of traceability trees allows to easily identify which sets of tests should be performed to verify certain functions. The realization of the validation documentation is an integral part of the production process of our software and its structure is made to comply with the current regulatory requirements , with particular reference to the GAMP . Particular attention is devoted to the description of the changes in different versions of the program, in order to make quick and optimized validation of updates. Blulink through some qualified partners and experts in the field, is also able to provide a complete service for the validation of their installation, to optimize time and costs for the maintenance of the validation status of your systems.

Benefits

The documentation structure provided by Blulink is made according to the requirement of GAMP (Good Automated Manufacturing Practice Guide for Validation of Automated Systems v. 4.0). This documentation is intended to demonstrate the compliance of Blulink to their specifications and regulations (eg . 21 CFR Part 11 Electronic Records, Electronic Signatures, U.S. FDA Final Rule - Annex 11 of the EUGMP guideline). Some examples are available (and therefore with considerable savings in terms of time & cost saving): System Installation Specification: indicates , through the Installation Specifications uniquely identified by a code, the requirements that must be completed during the application installation (supports the Installation Qualification phase of the system). Architectural Design Description: describes the system architecture, hardware and basic software that uses the system, the modules that make up the user interface and other systems , the logical organization of the data base, etc. . Entity Relationship Diagram: lists and describes using a graphical notation entities that constitute the system and the relationships between them. Functional Specification: describes, through specifications uniquely identified by a code, the functionality of each module (supports the phases of Operational and Performance Qualification System). Functional Test Specification: describes, through Specification Test (consisting of purpose, manner of performance and acceptance criteria) uniquely identified by a code , how to test the functionality of each module (supports the phases of Operational and Performance Qualification System). Traceability Trees: these operational documents allow you to connect to each document to its Test Specification and vice versa. Allow easy access to the documentation and in particular allow you to easily identify what tests to run to verify that the software functions. Release Notes: for each version of the system, this document describes the changes from the previous version. For each change, uniquely identified by number attributed by the management system changes, as well as its description, is shown the activity in the system for its implementation. Factory Acceptance Test (FAT) Report: For each version of the system is the document "Report test run " with the results obtained from the execution of the Factory Acceptance Test planned and executed before each release . Change Management: the management of change and their validation is particularly simple and focused. The documentation provided by Blulink allows us to clearly identify the changes from one version to another system. Also you can find easily the tests that have the task of checking the parts of the system subject to change. The end result is a system adapted to the requirements of the customer, which allows the rapid return on investment, ensure a significant competitive advantage and peace of operators and managers.