In Earlier post we understood what is project validation plan (PVP) & What Content should include in PVP?
Now in this article we are going to understand What is Configuration Specification, Its Roles & Elements in Computer system Validation.
What is Configuration Specification (CS)?
The Configuration Specification details the configuration parameters & how these settings address the requirements in the URS. This may be a standalone document or detailed in the FS.
Configuration specification is specific & describes in detail how the function will be configured, and what you must do to test the function.
The configuration specification includes the configuration items for the application hardware and software, operating system, interface (if any) and data for the implementation of system.
The Configuration Specification document is defined in order to describe the list of HW/SW components included in the Computerized System.
Here you define the configuration of the application required for your business purposes based on your requirements (for example, Audit Trail Settings, Electronic Signature, User Administration, Authorization Concept).
Functional and configuration specifications are not required when using commercial off-the-shelf software (Category 3). As a result, the extent of the testing performed would also be reduced.
System Configuration Specifications includes
- Hardware Configuration
- Operating System Configuration
- Software Configuration
- Interface Configuration
- Data Configuration
The Configuration Specification identifies the System Configuration Baseline addressing the SW components and interfaces and the System Parameters, focusing on the configuration items which may affect the GMP functionalities.
A Security Matrix is created (included in the document or in a separated document) in order to identify the user profiles defined in the system and the related functions included.
The assignment of the users to each profile shall be executed according to the security-related procedures. The document shall also describe the IT landscape on which the software resides and how it is to be connected to any existing system or equipment.
Therefore the document shall include also (or make reference to other document) a description of the system landscape and a specification of all elements shown on the Landscape (e.g. Operating systems, Middle ware, Ancillary Software e.g. PDF viewer, System environments, Interfaces, Relevant IT Infrastructure components e.g. Servers).
The CS describes how the system will be configured to match its functions to the business process. The actual configuration process usually occurs on-site after system installation, and may be performed by the system vendor.
The elements of the CS should now be recorded in the trace matrix beside the corresponding requirements and functions each configuration item is meant to satisfy.
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