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Pharma, Medical Device, Biotech Quality Manangement System Selection Guide

EQMS Software Evaluation & Selection Guide for the Life Sciences

EQMS - 3 February 2016

The EQMS Software Evaluation and Selection Guide has been designed by the SOLABS Quality & Best Practices Unit expressly to provide companies in the pharmaceutical, medical device, biotechnology, clinical trials, and research & development industries with a tool to help them evaluate various Enterprise Quality Management System software that they may be considering implementing.

The compliance/regulatory world is a shifting, changing one in terms of complexity, regulatory/legislative/compliance structures, and human fallibility with increasing training logs and document volumes. We are rapidly approaching the time when automation will be required to bring us in line with administrative realities.

EQMS Software Evaluation & Selection Guide (Pharma, Biotech, Clinical Trial, R&D) Snapshot
HOW TO USE: The Guide is simple and straightforward to use. Rate each EQMS vendor by category (a.-i. above) from 1-5 (5=best, 1=worst) and then give each category a weighting factor rating (from 0-1, e.g. 0.4, 1=crucial, 0=not relevant) based on how important that criteria is to your company. The Guide has been formatted to calculate totals and will present you with a total for each EQMS vendor on the final sheet.

SOLABS recognizes there are several EQMS options available to companies. We also understand that the selection process can be difficult, not the least because of the many factors involved: cost, implementation factors, the status quo, and who/what/how is being brought into compliance. These must all be carefully considered by a company when reaching a final decision about which EQMS is the best solution for them in the context of their operations.

This EQMS Software Evaluation and Selection Guide is designed to help facilitate the evaluation and selection process. It provides a listing of system features, functions, capabilities and factors in nine (9) different categories that a company may choose to evaluate: Features & Applications, Reporting & Analytics, EQMS Flexibility, Compliance & Validation, IT Requirements & Integration, Demonstrations, Financials & ROI, Implementation Services, and Vendor Information. Each company will examine the nine categories, and will find themselves on a spectrum somewhere there. They will at the same time recognize how their needs differ—even from companies of the same size in the same sector, for example–and consequently why SOLABS does not advocate a one-size-fits-all approach.

The Guide can be used in a variety of ways. It can be simply informative to those unfamiliar with EQMS software, or it can also be used quantitatively by applying different weighting factors to those attributes that a company determines are the most important to them. You’ll find subtle but important differences can be laid out and evaluated just by making minor tweaks to various variables.

"We understand that the [EQMS] selection process can be difficult, not the least because of the many factors involved: cost, implementation factors, the status quo, and who/what/how is being brought into compliance."

Brian Graeff
Head of the Quality & Best Practices Unit, SOLABS

We’d also like to note that although we are certainly Enterprise Quality Management Software experts, no one knows your company and your particular business better than you. The EQMS Software Evaluation and Selection Guide is intended to be used as a starting point to build your own Guide. We haven’t got every angle on this necessarily figured out, but we have taken the time to condense and synthesize conclusions from what we hear consistently from the field from companies evaluating EQMS solutions.

Companies usually require that the evaluation and the selection of an Enterprise Quality Management Software be a formal, objective, documented process for the comparison of the various systems under consideration. The EQMS Software Evaluation and Selection Guide provides an excellent tool for that purpose. Beyond the other help and considerable guidance SOLABS is able to offer you, the Guide allows your company to do some real fundamental research and examination that will, we are sure, come in handy at any point in the selection process!


About the Author
Brian Graeff is currently the Head of the Quality Best Practices Unit at SOLABS. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca and Sunovion Pharmaceuticals Inc.. Brian retired from Sunovion in 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and APIs with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table.

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