SimplerQMS Implementation

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.

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Get started fast

Our incremental implementation approach, where prioritized modules are implemented in just a few weeks will allow you to launch eQMS quickly.

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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.

Save time

SimplerQMS modules are already pre-configured, based on many years of experience working in the Life Science industry.

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Utilize templates

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.

Ensure competency

Get unlimited system training to ensure a high level of user adaption of the SimplerQMS solution in your organization.

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Standardize procedures

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.

analysis

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:

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Review your current Quality Management System content

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Perform a GAP analysis between your current content and regulatory requirements

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Review all your current document types

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Walk you through configuration decisions which are documented in a user requirement specification

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Capture requirements for eventual migration of existing documentation to SimplerQMS

QMS Analysis
Life Science Module Setup

configuration

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:

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Configuring system modules based on the implementation scope.

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Setting up roles and permissions for users, based on the structure of your organization, number of employees, specific access requirements, job roles, etc.

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Configuring views and dashboards for improved usability.

training

Get a high level of competencies in using eQMS

Our training process is mainly composed of instructor-led hands-on training and includes:

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Introductory sessions where you will be introduced to the system, its intended use, possibilities, and use cases.

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Our training coach will oversee your actions during given tasks, provide guidance and lead you to the correct objective.

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When you start using the SimplerQMS you have unlimited access to your training coach and our support team.

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We issue training certificates to the trainees.

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We supply you with a set of e-learning videos and written guidelines that explain the functionality of SimplerQMS.

QMS System Training
QMS System Migration

migration

Migrate all your documents safely and efficiently

The migration process typically consists of the following steps:

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Analysis of your historic documentation and create a migration plan.

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Migration of documents from the Quality Manual, Design History Files, and other relevant documentation is completed.

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Relevant documents go through a review and approval flow which creates the document baseline for SimplerQMS.

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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

resource requirements

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.

Time Resource Requirements

Trusted by companies around the world

The collaboration with SimplerQMS has lived up to our expectations. Their service has been superb and very supportive.

Niels Erik Holm
COO, Reapplix

During the implementation of SimplerQMS, the expectations of SimplerQMS’s team have been exceeded. We have got help – also at awkward hours of the day.

Louise Flintegaard Ehlert
QA Process Manager, Cortrium