Implementation Project Overview

Overall Sequence of Activities 

There are 6 to 8 main activities in the implementation project—depending on the SOLABS QM10 features selected by the client. No matter which features were selected, the implementation begins with the Overview Training Activity and ends with the Transfer to SOLABS Support Activity.  

Table 1: Complete List of Implementation Activities   

Each activity is explained briefly below:  

1. Overview Training—These are “Walkthrough Workshops” done in the client’s SOLABS QM10 “Sandbox” to allow clients to get familiar with the system and to help with the configuration of the SOLABS QM10. 

2. Strategy Discussions and Configuration of SOLABS QM10—This activity is to “customize” SOLABS QM10 according to the client’s needs.  This information is provided by the client in two documents: User System Configurations for SOLABS QM10 (EC-SOL-001) along with the User-Roles Migration Spreadsheet (UR-SOL-001).  There are two key parts: A) Users and Roles; B) Folder structure and document types. There may also be other additional configurations if requested.  

Table 2: Sample configuration elements 

3. (Optional) Validation of the entire SOLABS QM10, including the Document Control Process but not including other QM APPs—This is to ensure that the SOLABS QM10 is validated (IQ and OQ) per regulatory requirements. The validation consists of installation (IQ) and operational (OQ) qualifications to “demonstrate the suitability of computer […] software to perform assigned tasks”. Details are provided later in this document.  

4. Installation of the Core and Document Control Process—The Core and Document Control Process are the foundation of SOLABS QM10. This validated version will also be configured for the client’s users and their role assignments.  

5. (Optional) QM APPs—Examples of SOLABS QM APPs are Change Control, CAPA, etc. Activities for the QM APPs include training and, per regulatory requirements, validation (IQ and OQ) of the QM APPs.  

6. (Optional) Data Migration—This is for the transfer of documents and other data such as training records. This is usually limited to clients moving from prior releases of SOLABS QM10, another EQMS or where bulk uploads of documents and/or users are requested.

7. Handover Preparedness—About one month before the Handover date, SOLABS will prepare a Handover Countdown Checklist (HCC). This is a list of all outstanding activities/tasks that need to be completed before Handover.  

8. Formal Training—This is to provide hands-on training that is in preparation for the Go-Live and is scheduled just before the Go-Live date.  

9. Transfer to SOLABS Support—This is done once your company has decided to Go-Live with the SOLABS QM10.  

From the client’s perspective, the activities unfold roughly in the following sequence, with some activities occurring at nearly the same time as others:  

Figure 1: Approximate Sequence of Main Activities 

As shown in the table above, for instance, the first row of activities (1,2,3,4) will all start at about the same time and continue in parallel.