Implementation Methodology

Implementation Methodology

Products such as ELN, SDMS, DMS and InterFACER are implemented Out-of-the-box. We have a standard implementation methodology for all these products. Right from customer URS, validation (IQ/OQ), traceability matrix to URS are part of our standard implementation. These products are rarely customised.

LIMS implementations are projects that need to be managed well. Successful LIMS Implementation involves configuring or developing and delivering application based on the process study and understanding to fulfil the process needs. With years of close interaction with customers and delivering successful implementations, we have defined an Implementation Methodology to achieve successful implementation with customer satisfaction.

Successful implementation involves configuring and delivering application based on the process study and understanding to fulfil the process needs. With 20 years of close interaction with customers and many successful implementations, we have defined an Implementation Methodology to achieve customer satisfaction.

 

Out-of-the-Box vs. Custom is another consideration during implementation.

In the Out-of-the-Box implementation, the requirements are matched with the standard solution. With change management approach, we minimize deviations in the process by reducing the impact of change.

In a custom implementation, the process requirements are compared against the Out-of-the-Box solution and gaps are identified. The gaps are then reviewed and necessary changes updated in the project plan.

 

We follow a Five-Phased approach in all our implementations. This approach ensures:

  1. Implementation adheres to the guidelines as specified in GAMP®5 for computerized systems.
  2. Knowledge transfer process starts from the first phase to ensure that the users familiarize themselves with the system from the start of the implementation.
  3. Within each phase of the implementation, we adopt a Scrum model to ensure short cycles of goals and review.

 

The above approach has ensured high user acceptance and adoption of the implemented system while ensuring bugs and fixes are kept to a minimum. The dependency on us (the vendor) either by the System Administrator/ Power Users for routine needs after Go Live (after the hand holding period) is also not high.

The five phases and the steps in each phase are listed below in the following table along with the deliverables in each phase.

Column ~ refers to a phase

Row ~ refers to the steps in that phase

Initiation Design, Development& Testing Test Server Installation & Validation User Validation Closure / Support
  • Kick-Off
  • Workshop
  • Review project plan
  • System Design
  • DQ (Design Qualification)
  • Configuration / Customisation & Unit Testing
  • Installation in test server
  • IQ (Installation qualification)
  • UAT
  • Final Review & Corrections
  • Review Risk & Prepare for Go-Live
  • Go Live
  • Requirement Gathering & Gap Analysis
  • URS & FRS preparation
  • Integration and System Testing
  • Review & corrections
  • Administrator Training
  • Power User Training
  • End User Training
  • Update project documents
  • Hand holding (Live Support)
  • Solution Mapping
  • URS & FRS sign off
  • Update project plan
  • Legacy Data Migration
  • Reports Development
  • Project Documentation
  • Master data creation
  • Operational Qualification (OQ)
  • Master data
  • Performance Qualification (PQ)
  • Enrolment to Support Phase
Deliverables
  • FRS Document
  • Updated Project Plan
  • Design Document
  • Test Plan & test results report
  • Working version of software for UAT
  • Validation Documentation
  • Final version of software
  • Manual (Admin, User)
Contact Us

Not readable? Change text. captcha txt