Strategies for Addressing the Top 3 Quality Pains in a Regulated Environment

In the past 10 years that I’ve been working with highly regulated companies, I’ve seen many organizations find out the hard way that quality does not occur by accident. Quality requires good planning, design, and execution. 

The “quality pains” most companies experience stem directly from having an ineffective and inefficient quality management system (QMS), usually paper-based or hybrid. I will discuss the most common pains I’ve seen and offer some recommendations. If your company is developing a QMS or revamping your existing QMS, you may be familiar with some of these pains.

 (1) Administrative Burden: Typically when a company turns to MasterControl for help, it has already gotten in trouble with a regulatory agency or a customer. Many times it’s because the organization doesn’t have staffing to manage its quality system properly. If the system is paper-based or hybrid, quality issues are sometimes undetected until it’s too late because it’s impossible to catch those issues if information is buried deep in piles of papers and binders. 

Strategy: A company can greatly reduce its administrative burden—including routing, follow up, tracking, escalation, and approval—by automating routine tasks. For example, by switching to an electronic QMS, a MasterControl customer cut the number of people managing documents-based processes from 20 to five, freeing the 15 other staffers to do other tasks.
Scalability should be part of any company’s quality strategy. A manual system may be compliant, but the cost of maintaining it as an organization grows is going to be significant. The more products the company manufactures and the more regulations it complies with, the more documentation and tracking it must do. It would also mean more quality events to track, monitor, and trend, making spreadsheets increasingly hard to manage. I know of organizations that have literally filled warehouses with documents and records because they were resisting automation.

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(2) Training Burden: Managing the process of employee training and the related records is one of the best examples of an area heavy in administrative overhead. Let’s say your company has 100 employees and each of those employees is required to be trained in 20 SOPS and work instructions. This means that 2,000 tasks must be tracked to ensure the training is completed and 2,000 records must be captured with a signature and stored in an easily accessible repository.

This says nothing about actually carrying out the training event and testing employees to prove competence. What if the SOPs and work instructions are revised regularly? You can quickly see how an administrative “monster” is created. 

Strategy: A company can improve the training process considerably by switching to an electronic system. Companies that have turned to MasterControl to overhaul their training systems imported their training data into MasterControl and automated all training-related tasks. In addition, they created courses and exams electronically, greatly reducing their training burden, to say nothing of the forest of trees that was left unharmed. One customer extended its training system to its facilities overseas, where Spanish-speaking employees had the capability to select their language for training purposes.

(3) Managing Quality Events: When products or processes do not meet the specifications defined, events must be logged and evaluated, and appropriate actions taken. In a manual QMS, this means for every product nonconformance, process deviation, or product complaint, a record must be created and routed to the appropriate people for data entry and review. Based on the review, actions must be identified and carried out to correct the problem. Data from these records is often entered into home-grown databases or spreadsheets in hopes of identifying trends that management can review. But the burden of managing the records, work flow, and resulting data often makes it difficult for management to conduct critical reviews.

Strategy: An effective CAPA process is critical in addressing and mitigating the impact of quality events (customer complaints, deviations, nonconformances, etc.) and making sure that they don’t recur. At MasterControl, we believe that CAPA can be successfully implemented with the help of robust software and an effective closed-loop process. The software solution standardizes data gathering and simplifies CAPA implementation by providing an electronic process that will guide the quality team, from root-cause investigation through execution of corrective and/or preventive actions.

While the software solution provides the platform for the CAPA process, it’s not enough. MasterControl’s Quality and Compliance Consulting Team helps companies design and implement a sound methodology that’s replicable and reliable (1).

Don’t let administrative burden get in the way of good quality. The management of quality event processes, data analysis, and quality records should be a seamless part of your operations. Your focus should not be in addressing quality issues but in building your core competency and increasing your competitive edge in the market. Switching to an eQMS is a big step toward that direction.

Note: The views expressed in this article are those of the author and do not necessarily represent those of his employer, GxP Lifeline, its editor or MasterControl Inc.

Paul Sanderson is the head of MasterControl’s Solutions Consultants Group. He has spent the last decade helping almost 200 regulated companies choose the right eQMS based on their unique needs and implement it successfully. He has 10 years of enterprise software experience in the life science space.


  1. To learn more about MasterControl’s Quality and Compliance Consulting Team, go to: