Criteria for validating software requirements

In contrast, several risk-averse pharmaceutical companies choose to validate, in-depth, vendor-supplied pre-validated “standard” software.Intended use Intended use is defined as, “…facilitate operations for its intended use and for its cleaning and maintenance…” (1).Computer software, as part of the computer system, dictates the hardware on which to be executed.

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c 14 dating of dead sea scrolls - Criteria for validating software requirements

This term has shown to be a good and pragmatic guideline.

Users of computer systems can use the same term for computer systems.

This rather simple notion proves useful as it simplifies an initial complex and, for some users, volatile concept.

From an internal-external perspective, verification practices (e.g., validation strategy, proper risk assessment, establishment of design, user requirements, and subsequent verification of requirements) must be processed and reported internally to verify the intended use of the software.

Because of this attitude, users may rely too heavily upon vendor-supplied information and validation data to support their system validation.

Relying on vendor-supplied data could compromise the intended use of the software, and therefore, compromise the validation.

FDA issued warning letters in 2012 due to lack of documentation of intended use.

Fortunately, top management, quality executives, and engineers are becoming more aware of potential regulatory pitfalls and breaches as the industry becomes familiar with computer systems and generated data. FDA, 21 CFR 11, Electronic Records; Electronic Signatures 2.

The pharmaceutical company is obliged to identify all raw data associated with GMP decisions (e.g., batch release) and determine which format (paper or electronic) to maintain data in.

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