White Paper

Selecting, Implementing, And Using FDA Compliance Software Solutions

Source: EtQ, Inc.

We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”

As the world market evolves, product lifecycles are speeding up to accommodate market demand and keep up with competing products. As a result, Quality benchmarks need to evolve as well. Risk is fast becoming the benchmark for assessing Quality throughout an organization. This is because organizations need a systematic and objective way of looking at incoming information and making decisions on how best to manage Quality. Risk Management provides this benchmark—it allows for a quantitative method to review the data and come up with decision criteria to help make better decisions leading to better Quality. In this day and age, companies cannot afford to lag on their Quality—product lifecycles are moving too fast and companies cannot keep up. Risk has evolved over the years to be more quantitative in nature and is incorporated into traditional Quality models in order to keep up with the pace of the new markets. This evolution is seen in adopting risk matrices incorporated into multiple facets of the Quality dynamic; Complaints, Audits, Nonconformances, Corrective Actions, and similar functions all use Risk in some form or another. This is growing in interest to the point in which risk activities often govern the processes and are fully integrated in the traditional workflows.

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