Establish your eQMS in 5-6 weeks with our proven implementation method.
Fast system implementation
SimplerQMS uses a fast and proven implementation method. The implementation typically takes 5-6 weeks and gives you many advantages.
Get started fast
Our incremental implementation approach, where prioritized modules are implemented in just a few weeks will allow you to launch eQMS quickly.
SimplerQMS modules are already pre-configured, based on many years of experience working in the Life Science industry.
Get unlimited system training to ensure a high level of user adaption of the SimplerQMS solution in your organization.
Avoid validation tasks
You will not have to spend time and money on software validation as SimplerQMS is pre-validated, Part 11, GxP, and ISO 13485:2016 compliant.
Use ISO 13485:2016 and 21 CFR 820 compliant Quality Manual, Procedure, Form, and Instruction templates in case you don’t have a QMS in place.
Receive key procedures such as Document Control, Supplier Control, Training & Learning which are tailored for organizations using SimplerQMS.
implementation process overview
Implementation based on an analysis of your specific needs
The implementation process starts with the analysis of your needs and continues through configuration, training, migration, and an incremental launch of SimplerQMS modules. Let’s take a closer look at each of the steps.
The analysis of your current QMS content, including a GAP analysis. This followed by an online workshop where an implementation plan is designed.
Adjustment of the system setting towards your usability preferences and procedures, including the module setup based on the implementation scope.
The unlimited training composed of a variety of training materials and instructor-led hands-on training until you are comfortable with the system.
Migration of relevant documents from the Quality Manual and the Design History File, which also includes document review and approval processes.
Complete analysis to ensure compliance
Our project manager prepares a plan and helps assign your employees to the key SimplerQMS processes. An online design workshop is held where we complete the following tasks:
Review your current Quality Management System content.
Perform a GAP analysis between your current content and regulatory requirements.
Review all your current document types.
Walk you through configuration decisions which are documented in a user requirement specification.
Capture requirements for eventual migration of existing documentation to SimplerQMS.
Adjust the system specifically for your organization
At this stage, we adjust the settings of the system towards your usability preferences and organizational structure. Configuration of the system typically includes tasks such as:
Configuring system modules based on the implementation scope.
Setting up roles and permissions for users, based on the structure of your organization, number of employees, specific access requirements, job roles, etc.
Configuring views and dashboards for improved usability.
Get a high level of competencies in using eQMS
Our training process is mainly composed of instructor-led hands-on training and includes:
Introductory sessions where you will be introduced to the system, its intended use, possibilities, and use cases.
Our training coach will oversee your actions during given tasks, provide guidance and lead you to the correct objective.
When you start using the SimplerQMS you have unlimited access to your training coach and our support team.
We issue training certificates to the trainees.
We supply you with a set of e-learning videos and written guidelines that explain the functionality of SimplerQMS.
Migrate all your documents safely and efficiently
The migration process typically consists of the following steps:
Analysis of your historic documentation and create a migration plan.
Migration of documents from the Quality Manual, Design History Files, and other relevant documentation is completed.
Relevant documents go through a review and approval flow which creates the document baseline for SimplerQMS.
When SOP’s are approved, training activities are automatically created based on employee job functions.
We recommend that a formal audit is executed by an external auditor checking for regulatory, QMS, and planned project activity completeness. The migration is closed when planned activities are completed and no critical issues are unsolved
Establish an eQMS software quickly
The SimplerQMS implementation process typically takes 5-6 weeks from the first kick-off meeting to go-live. During this time the super-user needs to spend 1-2 days per week on the implementation. The key task of the super-user is the be the “SimplerQMS champion”, who will lead the internal change process. We will coach the super-user and give him or her the tools needed to complete a successful transformation. Super-users will also have the full capability of configuring the system and on-boarding new users. Regular users will need to spend between half a day to a full day on training during the end of the implementation.
All users are trained by SimplerQMS and will receive training certificates after successfully completing the training. Furthermore, new and existing users always have access to training videos, guides, and support from SimplerQMS.