Sharp Life Science (EU) Ltd.

Document Title: SOP Template

Document Number: TEM-0002 Revision: 02

Standard Operating Procedure

Software Development Life Cycle (SDLC)

Table of Contents
1. Purpose ........................................................................................................................................... 1
2. Scope ............................................................................................................................................... 1
3. Responsibilities ............................................................................................................................... 1
4. Required documents ....................................................................................................................... 2
5. Related documents ......................................................................................................................... 3
6. Definitions ....................................................................................................................................... 3
7. Process map(s) / flow chart(s) ........................................................................................................ 4
8. Procedure ........................................................................................................................................ 6
9. Records............................................................................................................................................ 9

1. Purpose

This procedure specifies the processes by which Sharp Life Science EU Ltd creates, updates and
maintains software products. The described process ensures that SLS Software products are
developed to meet the required standards. As such this document depends upon a number of work
instructions covering individual areas and activities that make up the Software Development Life
Cycle.

2. Scope

This procedure applies to all software being developed within Sharp Life Science where the
functionality to be delivered is either

 a software product
 an increment to an existing software product
 a software component of a product
o e.g. aQdrop routines
 a medical device
 a utility/test facility used for the production of a medical device

This procedure does not apply to

 software developed to support business processes

 software tools or utilities used to facilitate the development of software that is in scope (as
defined above)

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 aQdrop scripts

2.1. Quality and Safety

The required quality of the software dictates which processes within the SDLC are mandatory and to
what level they need to be formally documented.

At SLS there we have defined three levels based on the combination of Safety and Quality. The safety
and quality classifications for Software Products are:

 Medical Device Software

 Commercial Software
 Research Software

3. Responsibilities

The SLS Software Department is responsible for the Software Development Life Cycle which includes
the generation and maintenance of the Software Development Lifecycle SOP.

4. Required documents

4.1. External Compliance Documents

4.2. IEC 62304 Edition 1.1 2015-06: Medical device software – Software life cycle processes

4.3. ISO 14971-2007: Medical Devices – Application of risk management to medical devices

13485

Work Instructions that make up this SOP

4.1. Software Architectural Design WI

4.2. Software Requirements Capture/Backlog Refinement WI
4.3. Software Issue Management WI
4.4. Software Development Plan WI
4.5. Software Test Report WI
4.6. Software Safety and Quality Classification WI
4.7. Software Security WI
4.8. Software Licensing WI
4.9. Software Configuration Management WI
4.10. Software Version Control WI
4.11. Software Coding Standards C# WI
4.12. Software Coding Standards Python WI
4.13. Software Coding Standards Firmware WI
4.14. Software Operations and Maintenance WI
4.15. Software Verification and Validation WI
4.16. WI-0010: Software Test Protocol Completion WI
4.17. WI-011: Software Release WI
4.18. TEM-011: Software Release Template WI

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4.19. Software Traceability and Auditing WI

4.20. SOP-0010: Safety Risk Management

5. Related documents

5.1. Glossary of Terms – SLS Software

5.2. High Assurance Agile Development (TBD)

6. Definitions

SDLC – Software Development Life Cycle

The Software Development Life Cycle (SDLC) is a method used to design, develop and test to the
software.

The methodology may include the pre-definition of specific deliverables and artefacts that are
created and completed by a project team to develop or maintain an application.

SOP – Standard Operating Procedure

Controlled documents that define the specific quality management system processes and the
deliverables/controls necessary to ensure that policies are met.

Abbreviations and names should be in bold with longer descriptions underneath in plain text.
There is a page break in place after this sentence.>

Software Product – Any software artefact (from document to executable binary or collection
thereof) that adds business value by satisfying a defined set of requirements

Software Component – A software component is a unit of composition with contractually

specified interfaces and explicit context dependencies only. A software component can be
deployed independently and is subject to composition by third parties

Software System

Software Unit

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7. Process map(s) / flow chart(s)

The SLS Software Development Lifecycle, at the top level has been broken down into the following
activities. While these activities are strongly linked, they can be operated as independent activities.

 Software Requirements Analysis

 Software Incremental Development
 Software Deployment/Release
 Software Operations and Maintenance

7.1. Software Requirements Analysis

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7.2. Software Incremental Development

TBD Description

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7.3. Software Deployment/Release

Below is an overview of the reference WI-011: Software Release WI

7.4. Software Operations and Maintenance

This covers all the activities/processes required to ensure that Software Product continues to
perform to its intended purpose. Include retirement.

8. Procedure

8.1. Software Requirements Analysis

8.1.1. Capturing Request

Step Action Responsibility

1 Generate Request to “Product Owner” This can be any
This can take the form of either a Requirement, an initial User Story, or SLS Stakeholder.
an Issue, Risk or Bug. but typically, a
software product
user.
2 Create Backlog Item: Capture initial details Software
Product Owner

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Step Action Responsibility

3 Is Request Acceptable: Does request capture; a minimum level of Software
detail, a request that could be undertaken by the software Product Owner
department? If so status=”Accepted” elseif Request is not of sufficient
detail then; status=”Blocked” else; status=”Cancelled”
4 Generate Feedback: The request either cannot be progress or is not an Software
appropriate request for the Software Department. Product Owner
The Software Product Owner represents the Software Department
(and will usually consult with them) but has the final word on whether
a request is suitable. Note this is expected to be a rare occurrence and
that lack of detail is not a reason to cancel a request.
5 Conduct a Backlog Refinement activity as defined in Software
Ref 4.2. Software Requirements Capture/Backlog Refinement WI Product Owner

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8.1.2. Software Requirements Analysis

Step Action Responsibility

1 Establish intended use and therefore the Safety and Quality Software
classification. Product Owner
All requirements must explicitly state the Safety and Quality
classification.
In the case that the requirement is associated with a medical device
the requirement must additionally state the medical Device Software
classification as defined in IEC 62304 section 4.3
Note: TBD Misuse
2 Requirement Discovery: Discuss ideally directly with the requester or Software
with a representative. Outcome will be one of: Product Owner
1) Developed User Story(s)
2) Reviewed set Requirements
3) A raised Issue, risk or bug
3 Requirement Prioritisation: The Product Owner gathers an assessment Software
of the priority (as compared to existing requirements). This is likely to Product Owner
include referring to Programme Owners directives. This task should
also consider
1) Any associated safety concerns
2) Any dependencies on in-progress projects
3) The expected business value of the request
4) If the requirement un-blocks
5) Key risks associated with the requirement
6) Any key dates associated with the requirement
4 Requirement Estimation: The Product Owner introduces the details of Software Team
the requirement to the team quorum. The outcome shall be an (quorum)
estimate shall be captured as an ordinate value abstraction e.g.
1) Epic – likely to take multiple sprints (blocks of 2 weeks) to
implement
2) Normal Backlog Item – likely to take up to a sprint to
implement
3) Task – could be fitted into a sprint and use less than say 10%
of its capacity
Other example would be S,M,L,XL,XXL
Note: Estimated by the people doing the work.
5 Conduct Backlog Refinement as described in reference Software Software
Requirements Capture/Backlog Refinement WI Product Owner

8.1. Software Deployment/Release

Below is an overview of the reference WI-011: Software Release WI

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Step Action Responsibility

1 Create Package/Test release Candidate as defined Release
Technician/
Test Technician
2 Quality Gate ensures that the software release meets the Quality Owner
appropriate standards in terms of quality and
any appropriate regulations
3 Perform Release; Create Release Packages and Make Ship Decision Release Owner/
Test Technician
4 Rework: The product owner can request incremental changes to be Product Owner
made for example fixing of issues raised during testing
5 Abandon Release: The release owner can abandon the release Release Owner

9. Records

Electronic records are stored in MasterControl.

The electronic records to be stored are captured at the Work Instruction level. There are no
electronic records required to be stored at this level of document.

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