Software Life Cycle

1. Though there is no particular software development life cycle prescribed by The FDA, but the manufacturers needs to classify and follow what they feel appropriate.

2. According to the type of business and organization, the manufacturers needs to make a choice of a software life cycle model and development procedure.

a. The Medical Devices, May 1998 features the Guidance for the Content of Premarket Submissions for Software.

3. Following are the aspects that a Software Life Cycle should be equipped with:

a. One of the key roles of Software Life Cycle is Risk management
b. Software Life Cycle must be capable of making necessary evaluation and specification
c. Software Life Cycle should be equipped with outstanding and detailed design
d. Implementation (coding) is crucial part of the Software Life Cycle
e. Integration is also the part of Software Life Cycle
f. Validation must present there in the Cycle
g. Software Life Cycle should have outstanding Maintenance
h. Success of Software Life Cycle depends on some of its qualities. It should be logical, comprehensively documented, auditable, crystal-clear and results oriented as well.
i. The Medical Devices, May 1998 features the Guidance for the Content of Premarket Submissions for Software.

How traceability can be attained?

1. Maintaining a traceability analysis is very important because, it is liaison among the requirements, design formats, obstacles, and validation. Maintaining traceability between these actions and documents is of utmost importance as with the help of this you can easily track the necessary information.

i. The Medical Devices, May 1998 features the Guidance for the Content of Premarket Submissions for Software.

Traceability Ensure the application of the Life Cycle

1. The relationship between design inputs and design outputs is displayed by traceability.
2. Traceability helps in determining that whether that design is based on any previous plan and requirements.
3. Traceability assures that design specifications are properly confirmed.
4. Traceability should be flexible enough so that whenever required, necessary changes can be implemented.

Traceability across the Life Cycle

1. Analyzing the associated risk of the project
a. It helps to trace the possible obstacles and their specific causes
b. With the help of Life Cycle you can easily locate identified improvement to the possible obstacles
c. Find out the reason behind the software-related problems and their position in the system

2. Requirements Analysis and Specification
a. Find out ideal software solution according to the system requirements.
b. Sketch Software Requirements to hardware, user, operator and software interface requirements
c. Locate Software Requirements to Risk Analysis mitigations.

3. Design Analysis and Specification
a. You can sort out from High-Level Design Specifications to Software Requirements according to the project
b. The process locate Design Interfaces to hardware, user, operator and software interface requirements
c. Software Life Cycle assess the design for introduction of any problems

4. Analysis and Specification are needs to be designed
a. Traceability of Detailed Design condition is essential for an Advanced Design
b. Capability of displaying traceability of safety important software functions and safety vital software controls to the detailed design of the project

5. Source Code Analysis (Implementation)
a. The process locates Source Code for Detailed Design Specifications
b. It assess unit tests to Source Code and to Design Specifications
1. Confirm perfect rapport between the Source Code and Design Specifications

6. Integration
a. Outline integration tests to Advanced Design Specifications
b. Advanced Design Specifications can be utilized to set up a balanced approach to integration, to conclude regression testing at the time of change.

7. Validation
a. Outline the system tests to Software Requirement Specifications for the project
b. Use enormous types of tests for the success of the software solution
i. Design test cases like heftiness, stress, security, recovery, usability, etc to address concerns.
c. Check with the help of traceability to assure that the necessary level of coverage can be obtained.

Several plans are there for Traceability

1. Options
a. Manual methods

i. Word processors
ii. Spreadsheets

2. "Home-built" Automated Systems
a. Relational Databases

3. Commercial Automated Systems
a. DOORS
b. Requisite Pro