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How important is Software Operational Qualification?

Software operational project?qualification (OQ) is considered an obligatory item in validation project of computerized system for any regulated laboratory. Questions like: Is OQ really crucial to a validation project for software like a chromatography data system (CDS)? And how much value addition happens software OQ for commercially available software actually provide to a validation

Validationof computerized systems requires that a duly regulated organization functioningunder good manufacturing practice (GMP) or good laboratory practice (GLP) requirements develop or implement a system that generates documented evidence of the work performed and follows a predefined life cycle. The extent of work carried out on each system is dependent on the nature of the software used to automate the process. Using the approach illustrated in the ISPE's Good Automated Manufacturing Practice (GAMP) Guidelines, version 5 ("GAMP 5"), application software can be classified into one of following three software categories:

·                              commercially available nonconfigured product (category 3)

·                               commercially available configured product (category 4)

A reasonable and documented risk assessment is crucial for ensuring that the validation work can be defended in an audit or inspection. Therefore, the work that a laboratory needs to carry out will amplify with the escalating complexity of the software (5). This dialogue focuses on commercially available software i.e. GAMP software categories 3 and 4 (5, 6). The arguments offered here are not intended to be applied for custom software applications or modules such as macros or custom code addons to commercial software, which need a different approach.      

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Verification Stages of a Life Cycle

Terminology is vital to steer clear of misunderstandings. At the verification stage of a life cycle, the bought system and its components are installed and examined by the supplier (installation qualification or IQ and operational qualification orOQ and then user acceptance testing is performed against the specifications inthe URS (user requirement specification) to exhibit that the system is fit for proposed use (performance qualification or PQ).

• Installation and integration (IQ) — Following questions need to be answered at this stage: Do you have all of the items that you requisitioned? Have they been properly installed? Have the components been linked together properly?
• Supplier commissioning (OQ) — Does the system work as per the expectations of the supplier? This question is answered at this stage. Typically, this is carried out on a clean installation of the software instead of configuring specifically for the OQ.
•  User acceptance testing (PQ) — Does the system work as the user expects against the requirements in the URS? At this stage this question is answered. PQ will be performed on the configured application if you are using a category 4 application.

Subsequent to the successful completion of the user acceptance tests and writing of the validation summary report, the system is released for operational use. The above descriptions of IQ, OQ and PQ apply only to software and are not the same as outlined in the United States Pharmacopeia (USP) Chapter <1058> on analytical instrument qualification (AIQ) (7).

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