Software specifications
The foundation for successful software development
Clear requirements
Establish a mutual understanding of software
Project alignment
Ensure all stakeholders are on the same page
Risk management
Identify, analyze, mitigate, and monitor risks
Thorough software specification services for effective development
Software Specifications service encompasses detailed documentation and descriptions of how the software system will meet user requirements and achieve its intended use.
Our project managers, software engineering experts and application specialists prepare these documents in tight collaboration with our clients to establish a mutual understanding of all the details related to the desired behavior and design of the software system and build a solid foundation for risk management.
User Requirements Specification (URS)
URS outlines what the users need and expect from the software.
It focuses on:
User Needs and Expectations
Clear articulation of user requirements and expectations.
High-Level Functionality
Description of the high-level functionality that the software must provide, ensuring it makes sense for different operating systems.
Performance Criteria
Specification of performance criteria from the user’s perspective.
Stakeholder Involvement
Continuous involvement of all relevant stakeholders to ensure requirements are met and make sense throughout the product development process.
Software Requirements Specification (SRS)
SRS contains detailed information and descriptions of how the software system will meet user requirements. It includes:
Functional Requirements
Detailed requirements related to features from a user’s point of view.
Non-Functional Requirements
Covering technical qualities such as performance, durability, security, reliability, and uptime.
Collaborative Workshops and Meetings
Engagements to gather and refine requirements with clients.
Mockups and Prototypes
Visual aids to better understand and verify requirements.
Comprehensive Documentation
A detailed SRS document is a basis for system design, development project costs, and the project timeline.
Software Design Specification (SDS)
SDS contains detailed information on how the software will achieve its intended use by specifying the design of the software system. It includes:
Functional Specifications
Details on individual screens, features, functions, and user flows within the software.
Non-Functional Specifications
Specifications for user interface elements, technical architecture of the software system, management systems, and similar, considering different use cases.
Epics
Documents written in the form of Epics, used as a blueprint of how the software will be built.
Additional Documents
Preparation of additional documents such as Risk Assessment, Risk Mitigation, and Technical Decisions Document, supporting quality assurance.
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Frequently asked questions (FAQs)
What are software specifications for regulated software?
Software specifications describe what a software system should do and how it will be designed and developed. They provide the foundation for software development, testing, validation, and maintenance.
For medical device and IVD software, specifications also support software lifecycle processes under IEC 62304, including traceability between requirements, risks, implementation, and testing.
What is the difference between a URS, SRS, and SDS?
Software specifications are typically organized into three key documents:
- URS (User Requirements Specification) defines what users need from the system.
- SRS (Software Requirements Specification) defines what the software must do to meet those needs.
- SDS (Software Design Specification) describes how the software will be designed and implemented.
Together, these documents create a clear path from user needs to implementation, testing, and validation.
What is a User Requirements Specification (URS) in pharma software?
A User Requirements Specification (URS) defines what users need from a software system, including its intended use, key workflows, functionality, performance expectations, and relevant regulatory or operational requirements.
In pharmaceutical, laboratory, and life sciences environments, a URS typically includes:
- laboratory workflows and user expectations
- high-level functional requirements,
- data integrity and audit trail expectations,
- performance requirements,
- and regulatory requirements such as FDA 21 CFR Part 11 or EU Annes 11.
The URS serves as the foundation for software development, validation, testing, and compliance activities. A well-defined URS helps ensure that the final system supports both user needs and regulatory expectations.
What does a Software Requirements Specification (SRS) document include?
A Software Requirements Specification (SRS) document describes what a medical or laboratory software system must do and how it should perform.
An SRS typically describes functional and non-functional requirements, user roles, workflows, integrations, performance expectations, cybersecurity requirements, and other technical requirements.
The SRS acts as a blueprint for software development, testing, risk management, and validation. Clear and structured requirements help reduce development risk and support regulatory compliance throughout the software lifecycle.
Do we really need software specifications before development starts?
Usually, yes. Although creating software specifications requires time upfront, it usually reduces project risk, prevents costly rework, and helps teams align expectations before development begins.
Skipping software specifications may seem faster at the beginning of a project, but in regulated software development, it often leads to delays, costly redesigns, compliance gaps, and validation issues later.
For regulated software, specifications are important because they establish traceability between user needs, risks, implementation, and testing, supporting validation, audits, and regulatory compliance. For medical device software, documented software requirements are also part of the lifecycle processes addressed by IEC 62304.
Can you review our software specifications or architecture instead of developing the entire solution?
Yes. BioSistemika can review your software specifications, architecture, and supporting documentation, whether the project is developed in-house or by another vendor.
Our review helps identify gaps, inconsistencies, technical risks, and compliance issues before development, testing, validation, or regulatory activities begin.
We develop software in-house with the help of AI. Can you review our code?
Absolutely. In fact, we use AI ourselves. But generating code is only one part of developing high-quality software.
What matters most is ensuring that the software is reliable, maintainable, secure, and fit for its intended use. For medical device, diagnostic, and laboratory software, it must also meet regulatory expectations and be supported by appropriate documentation and traceability.
AI can generate code, but it cannot fully understand your product, its intended use, or the risks associated with it. Nor can it take responsibility for the final software. That requires experienced engineers with expertise in software development, the application domain, and the relevant regulatory framework.
Ultimately, responsibility for the software always remains with the development organization and, for regulated products, the manufacturer. An independent expert review provides additional confidence that your software is robust, compliant, and ready for the next stages of development, validation, or regulatory review.
What are IEC 62304 software safety classes A, B, and C?
IEC 62304 classifies medical device software according to the potential harm that could result from a software failure:
- Class A: no injury or damage to health is possible.
- Class B: non-serious injury is possible.
- Class C: death or serious injury is possible.
The software safety class affects the rigor of the software lifecycle activities required by IEC 62304, including development, documentation, risk management, verification, and maintenance.
For software that is part of a medical device or is itself a medical device, determining the appropriate safety classification early helps define the development and documentation effort required.
Comprehensive software development services
We support your software development project at every stage, from software documentation to UX design and cybersecurity, along with many other services, helping you bring your product to market faster.
