Software Quality Assurance Procedures

Having already specified, designed and developed leading- edge medical software to US Food and Drug Administration (FDA) regulated Standard Operating Procedures (SOPs), we are ideally placed to review or develop Software Quality Assurance programs for client companies and assist with the generation of software related procedures. Areas covered include:

·         Methodology and Process
For example, Configuration Management Guidelines, Software Development Policies and other Project Control related policies

·         Project Planning
Development of procedures to cater for planning documents such as a Software Development Plan (SDP) and Software Quality Assurance Plan (SQAP)

·         Software Requirements and Design
Generation of procedures for specification documents such as the Software Requirements Specification (SRS) and Software Architecture Design Specification (SADS)

·         Software Verification and Validation
Various test related procedures such as Software Validation Test Procedures (SVTPR) and the Software Verification and Validation Report (SVVR)

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Software Project Management
We can assist in a number of ways in the management of software projects for clients:

·         Project Estimation and Planning

·         Project Tracking and Management

·         Outsourced Subcontract Management
This would include contract monitoring, contract performance and general subcontract management.

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Software Specification, Design and Implementation
Software Engineering Services can be provided including:

·         Software Requirements Specification
Determination of the detailed requirements of a software application

·         Software Architecture Design
Design traceable to Requirements Specification

·         Construction and Implementation
Software coding to agreed standards and review cycles. Software component and integration testing performed during development

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Software Verification and Validation
Full software life-cycle verification and validation services are provided:

·         Verification and Validation Planning
This would include the provision of a master schedule and the identification of tools, techniques and methodologies to be used

·         Requirements Verification and Validation Tasks
These tasks would include the production of a Requirements Traceability Matrix along with formal and informal reviews of documentation

·         Design Phase
Activities would include verification of the design and production of the Software Validation Test Plan

·         Construction Phase
Source code verification and software component testing verification would be carried out at this stage

·         Validation Phase
Validation of the software would be conducted in accordance with the Software Validation Test Plan. A Software Verification and Validation Report would provide a summary of all verification and validation activities and results