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SOFTWARE VALIDATIONS

PROQUIFA CONNECT® generates records in the electronic logbook about the consumption of reference standards, that will be utilized by users to provide documented evidence of norms compliance. For this reason it is required to validate the computerized system.

What is the validation of the computerized system under NOM-059-SSA1-2015?

3.123 Validation, to the documentary evidence generated through the scientific collection and evaluation of the data obtained in the qualification and of the specific tests, throughout the whole life cycle of a product, whose purpose is to demonstrate the functionality, consistency and robustness of a given process in terms of its capacity to deliver a quality product. (NOM-059-SSA1-2015).

Documented process to ensure that a computerized system does exactly what it was designed to demonstrate functionality, consistency and robustness. Guaranteeing data integrity and security, product quality and compliance with applicable regulations.

3.116 Computer / computational system, for any equipment, process or operation that has one or more computers attached and associated software or a group of hardware components designed and assembled to perform a specific group of functions. (NOM-059-SSA1-2015)

Why is Proquifa Connectï¿½ validated under the 059 standard?

9.13.1 Computer systems that impact data integrity must be validated. (NOM-059-SSA1-2015)

9.13.3.3. When a computerized system generates electronic records and / or uses electronic signatures, they must be considered in the validation. (NOM-059-SSA1-2015)

9.13.3.3.1 Documents and records that are created, modified, maintained, archived, retrieved and / or transmitted through electronic systems are considered electronic records (NOM-059-SSA1-2015)

9.13.3.7 Based on a risk analysis determine the need for the system to include a data audit system, programmed to independently record the date and time of user log in, as well as actions to create, modify or delete electronic records . (NOM-059-SSA1-2015)

PROQUIFA CONNECT® features Audit Trail that records changes in the system. Both the electronic records and Audit trail can be subjected to audit by the corresponding sanitary authority. For these reasons it is required to carry out the validation of the computerized system.

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SOFTWARE VALIDATIONS

What is the validation of the computerized system under CFR 21 Part 11?

Sec 11.10 a) Systems validation is for ensuring accuracy, reliability, consistent performance and the capacity to discern invalid or altered records. (CFR 21 PART 11).

Documented process to ensure the accuracy, reliabi- lity, consistent performance and the capacity to dis- cern invalid or altered records.

Why is Proquifa Connectï¿½ validated under CFR 21 Part 11?