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The Right EQMS: The Best Investment You’ll Make This Year

Quality Management - 10 February 2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit

Why The Right Enterprise Quality Management System (EQMS) May Be The Best Investment You Make This Year

A pharmaceutical product has two main components: the dosage form, and the documentation that provides evidence of its potency, purity, and identity. We have tended to focus most of our attention on optimizing production of the physical product, and do not consequently proportionately invest in optimizing production of the documentation that also constitutes an essential part of its value.

As pharmaceutical production has evolved, decades of experience in designing quality into the product has identified some key areas for improvement:

Written specifications

Written procedures to govern manufacturing and testing

Batch records, including testing records

Training of production and quality personnel in the application of specifications and procedures

Strong change control practices to ensure documents are current

Periodic review to ensure compliance with registered specifications and processes

The challenge is to document all of these things without making the process of documentation itself a source of increased cost and potential error. The tendency to respond to every deviation or audit comment with more documentation and more explicit procedures can lead to a maze of documents that can impair the value that documentation is intended to add.

As it becomes easier to create documents electronically, we risk adding more complexity than is warranted. Thus simplicity and elegance of design should become increasingly important in our thinking; we must always remember we are designing tools for people to use in actual practice, not abstract documents with no grounding in reality.

"The right EQMS can can help you avoid the pitfall, as my former boss used to say, of "buying labor-saving devices, then hiring more people to run them"."

John Carkner
Sr. Consultant, SOLABS QA & Best Practices Unit

The use of a quality documentation system can address these issues and save a huge amount of redundant effort. The right EQMS can help you avoid the pitfall, as my former boss used to say, of “buying labor-saving devices, then hiring more people to run them”.

When evaluating the cost-versus-benefit of a quality documentation system, some of the factors to consider are:

The capital cost of the system

The capability of the system

The investment in training to get the system operating

The time required to sustain the system

Most critically, the return on investment or benefit the investment will provide

As we seek a systematic document management approach, we need to remember that any system is only as useful as the degree to which people understand it and use it. The most expensive system is the one that people work around–or avoid, leading to deviations and cost.

Defining the return on investment may require some differential analysis, since, in my experience, many quality departments are not good at breaking out and itemizing costs. While we may know our costs of production very precisely, quality costs can be lumped together, without much attention to detail on the cost of individual activities within the unit. Consider some of the following in the analysis:

Take a sample document & walk it through its life cycle process

From authoring and creation, through to review and approval, through training, to use, to archiving and finally to retrieval. Evaluate the hours spent, cost of failure at any point, and cost to change. The costs of the sample document can be extrapolated and multiplied by the document volume to estimate total document management costs.

Look at documents from a lean perspective

How much cycle time is consumed by document management? Financial analysis can estimate the cash-flow benefit of reducing cycle time. It is amazing how much time is consumed in the ‘order-to-cash cycle’ by documentation and review—typically much more than actual manufacturing time.

Estimate time saved by minimizing documentation, training and review time

If you add up the time saved across the organization by eliminating inefficient document processes, you will find resources of great value; time that was wasted on serving a cumbersome document system can be better spent on operational improvements, innovation and employee development.

Estimate the cost of prolonging regulatory or corporate audits if documentation retrieval is not fast & foolproof

There are two aspects to this—the disruption to productive work in tying up resources in inefficient audits, and the negative impression created, during audits for example, by not having a faultless system of document management.

In building a business case to evaluate document management practices, consider not only what is being spent, but the cost of wasted resources. A poorly functioning system isn’t just wasting the initial cost and maintenance cost; it is robbing the organization of the ability to invest in operational efficiency and employee development, and holding back the progress the organization needs to keep pace in an evolving and competitive industry.

I encourage you to start thinking of using an EQMS for document management not as a cost, but as an opportunity!


EQMS Software Evaluation & Selection Guide for the Life Sciences

About the Author
John Carkner is Senior Consultant in SOLABS’ Quality Assurance & Best Practices Unit and has had a career spanning more than 35 years in the pharmaceutical industry. A microbiologist by training, he began his career in Quality Control with Pfizer Canada. John gradually took on more responsibility, including overall Quality for Pfizer’s Canadian manufacturing operations, eventually became Site Leader of their Arnprior, Ontario manufacturing site. When Pfizer divested the Arnprior site in 2009, John began a new phase of his career leading a contract manufacturing organization. He concluded his career as President and CEO of Pillar5 Pharma Inc., and after five years in contract manufacturing, moved to a less structured role as a consultant to the industry.

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