Implementation of SOLABS QM10, Rollout Guide

What to Expect During Your SOLABS QM10 Implementation

Implementing a new eQMS is an important project, and knowing what to expect can make the process much smoother.

Your SOLABS QM10 implementation is a collaborative effort between your team and SOLABS. Throughout the project, we will guide you through configuration, validation, training, handover, and preparation for Go-Live.

This article provides an overview of the implementation journey, your team's responsibilities, and the key milestones along the way.

The SOLABS QM10 Implementation Journey

Every implementation is slightly different depending on the SOLABS QM10 functionality, QM Apps, integrations, and services included in your project.

In general, your implementation will include:

1. Project Kick-Off
2. SOLABS QM10 Overview & Workshops
3. System Configuration
4. Installation & Validation
5. QM App Implementation, if applicable
6. Data Migration, if applicable
7. Handover Preparation
8. Formal Training
9. Transition to SOLABS Support
10. Go-Live

Several of these activities take place in parallel rather than one after another. For example, configuration, installation, training workshops, and validation activities may all be underway during the same stage of the project. Rollout Guide - SOLABS QM10

1. Project Kick-Off

The Kick-Off Meeting marks the official start of your implementation project.

During this meeting, we will review the project at a high level, including:

• Project scope and key deliverables
• Expected timeline and Handover Date
• Roles and responsibilities
• Key project risks and dependencies
• Communication and meeting cadence
• Next steps

You will also meet the SOLABS team members who will support your implementation.

The Kick-Off Meeting typically lasts 60–90 minutes. Rollout Guide - SOLABS QM10

2. Getting Familiar with SOLABS QM10

Early in the project, your team will participate in walkthrough workshops led by a SOLABS Product Specialist.

These sessions are designed to familiarize your project team with SOLABS QM10 while helping you make decisions about how the system should be configured for your organization.

The overview training generally takes approximately three hours and may be divided into two or three sessions.

Your team will also receive access to a Sandbox environment, where you can explore QM10 and gain hands-on experience before working in your validated environment. Rollout Guide - SOLABS QM10

Tip: Use the Sandbox as much as possible during implementation. The more familiar your project team becomes with QM10, the easier it will be to make configuration and process decisions.

3. Configuring QM10 for Your Organization

Your SOLABS Product Specialist will work with your team to define how QM10 should be configured.

Configuration may include:

• Users and roles
• Role assignments and permissions
• Document folder structures
• Document types
• Metadata and system attributes
• Custom lists
• Document workflows
• Review and approval requirements
• PDF rendering templates

Depending on your project, configuration may also include integrations such as Microsoft 365 Collaborative Review or a training assessment platform such as Questionmark. Rollout Guide - SOLABS QM10

Configuration information is documented in the appropriate project configuration documents and reviewed with your SOLABS team.

4. Validation

Validation activities are an important part of the QM10 implementation.

SOLABS will introduce your team to the Validation Package and explain the documents that require your review and approval.

Validation activities use an IQ/OQ/PQ framework—Installation Qualification, Operational Qualification, and Performance Qualification—to provide documented evidence that the system has been installed, configured, and operates as intended. Rollout Guide - SOLABS QM10

Your organization will be responsible for reviewing and signing certain validation protocols and summary reports.

Signing these documents is important because it both documents your organization's approval and allows the implementation to progress to subsequent stages. Rollout Guide - SOLABS QM10

5. Implementing QM Apps

If your implementation includes additional QM Apps, these are typically introduced after the SOLABS QM Essentials have been validated.

Depending on your scope, these may include processes such as:

• Change Control
• CAPA
• Deviations
• Complaints
• Other quality processes included in your agreement

For each applicable QM App, your team will participate in a walkthrough, review the appropriate configuration, and complete the required validation activities before the App is considered validated for your organization. Rollout Guide - SOLABS QM10

6. Data Migration, If Applicable

Some implementations also include migration of existing information into QM10.

This may include items such as:

• Users
• Roles
• Documents
• Other agreed-upon data

The scope and effort associated with data migration are established before rollout. During migration testing and final migration activities, periods of system unavailability may be required. Rollout Guide - SOLABS QM10 Rollout Guide - SOLABS QM10

7. Preparing for Handover

Approximately one month before the planned Handover Date, your SOLABS Project Owner will prepare a Handover Countdown Checklist.

The checklist identifies the remaining activities that need to be completed by both SOLABS and your organization before handover.

Its purpose is simple: make sure everyone knows what remains to be done so the transition can be as smooth as possible. Rollout Guide - SOLABS QM10

8. Formal Training

As Go-Live approaches, SOLABS provides hands-on training for your organization's Super Users and Trainers.

Training focuses on the workflows and activities your team will need to operate and maintain QM10.

Your organization should also establish its own training plan for end users. The individuals trained by SOLABS can then help prepare and support the broader organization. Rollout Guide - SOLABS QM10

9. Transition to SOLABS Support

Near the end of implementation, your team will be introduced to SOLABS Support.

We will explain how to contact Support, how the support process works, and the levels of support available according to your agreement.

Your organization will also identify the appropriate points of contact for future support communications. Rollout Guide - SOLABS QM10

10. Go-Live

The Go-Live Date is selected by your organization and represents the point at which you begin using SOLABS QM10 as part of your day-to-day operations.

Go-Live does not necessarily mean that every user and every process needs to start on the same day.

Some organizations choose a phased rollout, introducing users, departments, processes, or training activities gradually. This can help manage organizational change and reduce the workload placed on Super Users during the initial rollout. Rollout Guide - SOLABS QM10

What We Need From Your Team

A successful implementation requires active participation from both SOLABS and your organization.

Your team's main responsibilities include:

• Designating a client-side Project Manager
• Participating in workshops and training
• Providing configuration requirements and information
• Reviewing and approving validation documentation
• Preparing and approving client-specific deliverables
• Providing appropriate IT support when required

The client Project Manager plays an especially important role in keeping activities, deliverables, and milestones moving forward. Rollout Guide - SOLABS QM10 Rollout Guide - SOLABS QM10

A Tip for Keeping Your Implementation on Track

Start gathering information early.

User lists, roles, permissions, document structures, process owners, and other configuration requirements can often be prepared before the associated workshops.

Providing complete information and reviewing project documents promptly helps keep the implementation moving toward the planned Handover Date. Rollout Guide - SOLABS QM10

How Long Does an Implementation Take?

A typical SOLABS QM10 implementation project is planned over approximately 4–8 months, depending on the scope of the project. Rollout Guide - SOLABS QM10

The timeline may vary based on factors such as:

• Number of QM Apps being implemented
• Data migration requirements
• Configuration complexity
• Availability of client resources
• Document review and approval turnaround
• Changes to the original project scope

The project plan is updated regularly throughout implementation so both teams can monitor progress and understand any impact on the expected Handover Date. Rollout Guide - SOLABS QM10

Handover Date vs. Go-Live Date

These two dates are related, but they are not the same.

Handover Date — The date when SOLABS considers QM10, or the applicable portion of the system, ready for your organization to use in production.

Go-Live Date — The date selected by your organization to begin using QM10 in day-to-day operations. Rollout Guide - SOLABS QM10

This distinction gives your organization flexibility to coordinate Go-Live with internal training, change-management activities, and operational priorities.

Working Together for a Successful Implementation

Implementing an eQMS involves technology, processes, validation, training, and—most importantly—people.

Throughout the project, your SOLABS team will work closely with your Project Manager and key stakeholders to guide your organization through each stage of the implementation.

Regular project meetings, clear communication, timely decisions, and active participation from both teams are the best ways to keep the project moving forward and prepare your organization for a successful Go-Live. The rollout guide recommends weekly or bi-weekly project meetings between the SOLABS and client project managers to monitor activities, budget, and timelines. Rollout Guide - SOLABS QM10

I would publish this as the main client-facing KB article and keep the original Rollout Guide as the more detailed reference document. The KB article is much easier for a new client to digest and answers the practical question: “We just signed with SOLABS—what happens next?”