SAGA by Verheim
Turn project input into GxP deliverables with defined workflows and templates adapted to your procedures. Your specialists direct the work, review the content and make the decisions.
Illustrative requirement-preparation example. The workflow and template are adapted to the task.
Already using AI?
Your people may already use AI to think through a question, compare information or prepare a draft. The next question is how that work fits your procedures, draws on relevant experience and produces what your team actually needs.
SAGA brings the professional method into the workflow: selected roles, relevant questions, project context and clear expectations for the deliverable. The instructions behind that method are prepared in advance and adapted to your organization.
Your team can build on a shared approach instead of having each person define the method again. Your specialists still direct the work, assess the content and make the decisions.
What could your team do with a shared method for work it repeats?
Explore the method →Relevant professional methods, your organization’s context and a defined deliverable shape the workflow. Each has a practical role.
Selected professional roles bring relevant methods and questions into the work. Your specialists use that support to examine the input, consider different perspectives and decide how to proceed.
Your procedures, project scope and relevant working material shape the workflow. Selected experience from earlier cases can inform the work where it is relevant. Customer-adapted instructions bring your way of working into the task.
Customer-adapted templates define the expected content and structure, including how related deliverables fit together. Your team has a clear target to work toward and review against.
Defined roles. Connected work.
Different parts of a project need different professional methods. In this CSV example, named agents support project coordination, requirements, risk, design and validation. Your specialist chooses the role and task, works through the questions and reviews the contribution.
A CSV workflow, based on the SAGA Agent Guide
Project Coordinator
Establish the project context, plans, procedures and templates the other agents work from. Return to Petra to record meetings and decisions, maintain the document register and work through review comments.
Requirements Analyst
Turn business discussions and discovery input into user requirements. Alicja helps prepare the URS, giving the later risk, design and validation work a shared starting point.
Risk Specialist
Examine the requirements using the project’s risk procedure and scale. Rasmus helps prepare the system risk assessment, informing the controls and test depth your specialists consider.
Design Engineer
Bring requirements and risks into the configuration specification. David supports the design work and checks consistency with related project material before the specification goes forward.
Validation Specialist
Prepare the validation plan, configuration verification and UAT/PQ scripts from the relevant project material. Vera also supports the project’s traceability matrix. Your team executes the tests and approves the records.
Start by establishing the shared project context with Petra. Choose the agent for the next task, select the relevant workflow and work through it together. Requirements then inform risk, configuration and verification work. Capture decisions and handovers at the end of the session, confirming what is recorded so the next session can build on it.
This is one CSV workflow. Roles, tasks and templates are selected for the agreed module and project; your designated people remain responsible for performing, reviewing and approving the work.
One task, made concrete
Illustrative workflow
Before a requirement is drafted, define its purpose, the relevant project input and what the deliverable needs to contain.
In a supported validation workflow, your specialist works with SAGA to prepare the requirement using relevant questions, project context and the expected document structure. The specialist assesses the content and confirms the requirement before it is saved. The confirmation is recorded.
The draft is then assessed against its purpose and expected content. Formal review and approval follow your procedures.
Illustrative workflow
A generic requirement-preparation example, not a customer document or a product screenshot. The named roles above illustrate how contributions to one CSV task fit together; your specialist directs the work.
SAGA Hub
A decision in one part of a project can matter to someone working on another. SAGA Hub carries published messages between project participants, so findings, decisions and handovers can reach the people whose work they affect.
Participants work with their agents to read the messages and consider the implications in their own project context. A technical finding can be explained in terms another specialist understands, with proposed follow-up for that person to assess.
A project update
Share the decision and its context.
What does this mean for the specification?
What follow-up should we consider?
Illustrative coordination example. Each recipient assesses the update with their agent and decides how to follow up.
Organize the project participants and their access, and connect their working areas to the project.
Publish a relevant decision, finding or handover through the Hub. Recipients can read and acknowledge the message from their own working context.
Use the recipient’s agent to examine what the update means for their work and consider the next steps. Your people assess and decide how to follow up.
Hub carries the messages. Your people make the decisions. Formal approval stays in your controlled systems.
Let’s talk about coordination →Four modules. A shared approach.
CSV, Equipment Validation, Deviations and CAPA are available at launch. Each starts with the task, your procedures and the deliverable your team needs. We define the relevant workflow and templates for your scope, with your specialists directing and reviewing the work.
Available at launch
Bring requirements, risk, configuration and verification into a structured way of working. SAGA’s roles help prepare the agreed deliverables using your project context, procedures and templates.
User requirements, system risk assessment, configuration specification, validation plan and test scripts. The CSV example above shows how these contributions fit together.
Available at launch
Bring the equipment’s intended use, relevant project material and validation requirements into the work. SAGA supports preparation through defined methods and templates, with your specialists assessing the content.
A requirement prepared for specialist review, as illustrated above. Additional deliverables are defined for the agreed equipment-validation workflow.
Available at launch
Find how similar deviations were handled before starting again. SAGA helps describe the event, find relevant earlier cases and work through a risk-proportionate investigation using your procedures and templates. Prepare the deviation report and the rationale for a disposition, with your specialists assessing the findings and Quality making the decision.
A deviation report for specialist review, supported by the disposition rationale and a CAPA handover where needed.
Available at launch
Carry the case from initiation through to effectiveness assessment. SAGA helps investigate the problem, prepare an action plan with owners and deadlines, and define effectiveness criteria before implementation. Capture the work and evidence in one evolving CAPA record, preparing the material your Quality team needs at each review and approval stage.
A CAPA record with packages for initiation, plan approval, closure and effectiveness assessment. Your designated people approve the plan, and Quality authorizes closure in your QMS.
SAGA supports the work and prepares the deliverables. Your specialists assess the professional content and decide whether it meets the purpose. In Deviations and CAPA, the user confirms each draft before it is saved. SAGA prepares the working material; your people assess the professional content and make the decisions.
Each review finding remains open until a named person resolves it or accepts it in writing with a reason, tied to the exact version reviewed. Export is blocked while a review is missing, out of date or has an open finding.
Your designated people formally review and approve under your procedures in your controlled document system. SAGA does not sign or write to your DMS/QMS.
Context for the next person
Why was that requirement written? Which alternatives were considered? What constraint shaped the decision?
Recorded decisions and working material help people taking over equipment or software understand the documented solution and continue the work. The decision context accumulated this way is what we call GxP Intelligence.
Selected experience from earlier work can also be brought into relevant methods and instructions. That is a deliberate choice about what to reuse; experience does not automatically change the shared methods.
A closer look
Your organization and the shared method.
The relevant procedures, project context, workflow instructions and deliverable templates are adapted to the agreed scope. Professional methods provide the starting point; your organization defines how the work should be carried out and reviewed.
The roles and workflows are selected for the work in scope. SAGA provides access to relevant complementary methods; it does not change who is authorized or qualified to perform, review or approve the work.
Defined workflow steps, relevant questions, content expectations and review requirements. Your team applies the method to the task and assesses the professional content. AI outputs can vary; the method gives the work a shared structure.
People work with an agent through defined workflows and customer-adapted templates. The prompt engineering for the method is prepared in advance; people still interact with and direct the agent as they work. The AI runtime is your own agent under your governance; SAGA does not train its own model; experience does not automatically change the shared methods.
SAGA brings prepared professional methods, customer-adapted instructions and defined deliverable structures into the work. People still interact with and direct their agent; the shared method provides a common starting point.
Your specialists assess the professional content, resolve questions and make decisions. Formal review and approval remain with your designated people, in your controlled document system and under your procedures.
Your procedures, project scope and relevant working material shape the workflow through customer-adapted instructions and templates. The implementation scope determines what is configured.
Choose a familiar task or deliverable. Bring the questions that take time, the input your team uses and an idea of what a useful result needs to contain.
A closer look
The work uses relevant, authorized project material. In Deviations and CAPA, you provide files such as event records, procedures, investigation results and earlier cases. SAGA imports the material for use in the work; these modules do not require a connection to your source systems. Where a source connection is agreed for another workflow, it requires an established connection and permissions; that setup is scoped for the engagement.
Yes. Imported earlier deviations can be searched by relevant case details, helping your team examine whether an event has happened before. Earlier CAPAs can inform the question: what did we do last time, and did it work? Your specialists decide what is relevant to the current case. This does not replace trending across your QMS or your management review.
We state the configurations a module is built and checked for. Changing to a different model requires re-checking against the workflow requirements. Scope and responsibilities are discussed for the specific engagement.
SAGA prepares deliverables. Formal approval and controlled records remain in your systems under your procedures. SAGA does not write to your DMS/QMS and does not sign.
SAGA brings prepared professional methods, customer-adapted instructions and defined deliverable structures into the work. People still interact with and direct their agent; the shared method provides a common starting point.
Your specialists assess the professional content, resolve questions and make decisions. Formal review and approval remain with your designated people, in your controlled document system and under your procedures.
Your procedures, project scope and relevant working material shape the workflow through customer-adapted instructions and templates. The implementation scope determines what is configured.
Choose a familiar task or deliverable. Bring the questions that take time, the input your team uses and an idea of what a useful result needs to contain.
Tell us about work your team repeats, the deliverable you need and what you would like to improve. A few lines are enough to start. We can explore a relevant workflow and show how the method could fit your team.
Let’s talk about your work
Tell us about a task that takes more time than it should. We’ll explore how SAGA could support the work, show you the method and discuss what a useful comparison would look like for your team.
No detailed brief needed. A few lines about your task are enough.