Some QA definitions

definitions

Some QA definitions

Qualification – applies to hardware, devices; not the process in which the hardware is used. Thus, verifies the hardware is suitable to do a task.

Verification – applies to the evaluation at intermediate steps when the software is developed to check for the correct approach to the final product.

Validation – applies to the actual process and it ensures proper operation of entire processes; verifies that software and qualified hardware are suitable to do a process that would be included in many tasks.

Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” QSR 21 CFR Part 820.3 Definitions; 1997

Computer System Validation (CSV) – process validation of a system which includes qualified hardware, operating system, software applications, configuration settings, security settings, interfaces, additional software components (utilities), SOPs, training, and details of the process flow.

Installation Qualification (IQ) addresses installation instructions and verification that installation is correct with respect to requirements and specifications; if it isn’t installed correctly it cannot operate correctly; often performed by the vendor.

Operational Qualification (OQ) addresses verification that functionality meets manufacturer specifications; often performed by the vendor.

Performance Qualification (PQ) addresses verification that functionality meets user’s needs, specifically real life conditions on real products; performed by the users NOT the vendor.

Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

IaaS – Infrastructure as a Service – most basic form of cloud service where providers supple resources on demand from their large pools installed on the servers/data centers

PaaS – Platform as a Service – on a cloud model, the providers provide a computing platform including operating system; programming execution environment; database,; web server… the resources are automatically managed.

SaaS – Software as a Service – again on a cloud model, the providers install and operate application software and it is accessed to cloud users.

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