Computerized System Validation: Be ready for audit! by Steve McBraun

Author:Steve McBraun [McBraun, Steve]
Language: eng
Format: mobi, epub
Published: 2020-11-17T16:00:00+00:00

10. How is the traceability of a CSV project carried out?

What?

Traceability establishes a link between two or more products of the System development/validation process.

Traceability ensures that:

➢ the requirements are fulfilled and can be traced in the corresponding configuration or in the designed elements;

➢ requirements have been verified and can be traced back to verification/verification that shows that the requirements have been met.

To ensure traceability of the computerized systems project, it is necessary to create and maintain ways to link the relevant specifications to testing and from testing back to the relevant specifications.

For what?

Project traceability helps to ensure that the computerized system is suitable for its intended use, as well as to avoid increasing the overall cost of projects by early detection of defects and solving problems.

Accurate traceability can also provide an advantage in:

➢ ensuring more effective risk management and project assessment/review processes;

➢ judging the potential impact of the proposed changes;

➢ facilitate/facilitate risk assessment for proposed changes;

➢ defining the scope/area of regression testing for changes;

➢ the ability to respond quickly and accurately during the audit.

Traceability provides a method to ensure that all valid elements of a specification, including requirements, have been verified. It also makes it easier to identify the documentation during regular inspection. Accurate traceability depends on the completeness and accuracy of specifications. The level of detail of traceability and volume of documentation should be based on the risks, complexity and novelty of the System.

How?

Traceability can be achieved in several ways:

➢ traceability matrix (TrM);

➢ automated software tools;

➢ spreadsheets;

➢ nested links directly into documents.

For 1st category. Traceability can be achieved through common and consistent numbering of requirements and cross-references can be included in documents.

For 3rd category. You only need to trace the path between requirements and relevant testing.

For 4th category. Traceability can be either a matrix or a reference to configuration items, providing traceability between user requirements, configuration and verification.

For 5th category. Traceability should be provided based on the requirements for each level of specification for appropriate verification.

The traceability matrix can be extended by adding additional information such as:

➢ a short written description of each requirement, (to confirm that the matrix contents are correctly referenced);

➢ change control numbers, (to track the history of the system and the consequences of changes);

➢ links to other documents and processes;

➢ data on the criticality of requirements to facilitate test levels applies to any given requirement (for high criticality requirements more detailed testing can be applied and thus refer to multiple tests, while low criticality requirements can refer to a single test);

➢ data on the fulfillment of the requirement by a specific procedure together with a reference to the procedure number and version;

➢ testing stage;

➢ test date;

➢ location/environment for testing.

In large projects, other tools can be used, such as document management systems that have the ability to maintain links between documents (both in the document management system and links to documents are generated and stored outside/outside).

Where?

Traceability strategy should be established during planning. The process used to achieve traceability should be an integral part of the System life cycle, documented and approved during the planning phase.

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