Walk into a pharmaceutical or medical laboratory and a couple of things will strike you. First, everything is unsparingly clean. Second, due to regulations and quality standards, those who work in these labs have excruciatingly specific protocols and procedures to follow. They are well trained and intensely focused on quality.

Quality is critical

Jim Todaro is Alpha Analytical’s (Westborough, MA) Quality Assurance manager. Over his 40-year career, he’s seen it all. His experience as a lab director, an entrepreneur, and an innovator makes him a powerful advocate for quality at Alpha.

“We are a lean organization—constantly trying to improve our processes while cutting away the waste,” explains Todaro. “That’s what drives us to improve our quality each and every day.”

A continuous improvement environment, like the one at Alpha Analytical, leads to innovations that may not be readily seen in other types of environments. Such was the case when the company recently faced challenges with its document management.

“Monitoring and keeping track of paperwork was very laborious for everyone involved because we had thousands of documents to control,” Todaro says. With more than 250 employees and a state-of-the-art 50,000-square-foot facility, it became troublesome when someone needed to track down a particular document.

Until now, a spreadsheet was used to keep track of everything. Moving documents through the system for approval was slow and inefficient, so the company took steps to investigate whether an electronic document management system would help. Systems such as Qualtrax weren’t really being used within environmental laboratories, and the few systems that were being used did not address Todaro’s needs. Qualtrax, however, seemed to fit his requirements.

Implementation

Sometimes implementing a new system can ruffle feathers and put staff on edge. That was not the case with Alpha Analytical, Todaro says. “There wasn’t a manager in sight who was against this move. Our team was living in a nightmare of paperwork—it was all-consuming. Everyone wanted something better.”

But that didn’t mean that the company rushed to implement the document management system. Instead, the staff spent time carefully planning the implementation. They created a team that included Human Resources, IT, and Quality Assurance. They also put a plan together with a timeline that included a heavy focus on training. All in all, Alpha invested three to four months to prepare for the system’s implementation.

“Our staff caught on pretty quickly,” says Todaro. “And they continue to fine-tune the system so that it meets our lab’s needs.”

After implementing the system in spring 2012, Alpha Analytical saw tangible benefits. Staff are now more involved and invested in the quality assurance process. They own their own documents and are able to make changes to those documents and then release them effortlessly to their colleagues for review and approval. The approval process that once took three to six months is now almost immediate.

Alpha’s auditors have raved about the new system. “You can sit them in a room and put Qualtrax up on the big screen and everything is right there,” says Todaro. “So far, we’ve received nothing but positive comments from our auditors.”

Half the story

But document management is only half the story, says Todaro, and this is where the culture of innovation at Alpha Analytical can really be seen. As Todaro and his Quality Assurance team began to share the system with colleagues outside the analytical laboratory environment, they began to ask, “Can you put that in Qualtrax too?”

The workflow feature of the software, which enables a company to develop and then manage and track common business processes, became attractive to other departments. The Health and Safety manager asked whether accident reports could be tracked. The Instrument group wanted to know if the software could track the movement of instruments from one facility to another. Other departments wanted to know whether the system could track vendor issues or customer complaints.

Todaro’s short answer was a resounding yes. He and his team began expanding the system’s reach beyond the lab, and all signs point to continued expansion. “Could the workflows become even more important than document management for us?” asks Todaro. “Maybe,” he offers with a smile.

Tips for implementing a document management system

What does it take to implement a system and make it useful within your own lab? Todaro and his colleagues offer these tips:

1. Know your requirements. Get a team together and spend time outlining what you want a system to do for you. Then go see such a system in action—in a real-life environment.
    
2. Have a plan. Your success in implementing a new system will be determined by how well you planned. Who needs to be involved? (Hint: Think beyond Quality Assurance people.) What are individuals’ roles? What’s the timeline? What are the potential risks, and how will you manage them?
    
3. Run the implementation as you would a formal project. This type of formality can help you address issues that come up and will ensure that the appropriate people remain involved each step of the way.
    
4. Train. Train. Train. Make time for training your staff in the plan and devote the resources to do it well.
    
5. Be innovative. As you implement the system, look for interesting ways to optimize your investment. Encourage your team to think broadly. Who knows? It may grow your culture while improving your business