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The Bode Cellmark Forensics is a private laboratory that provides forensic DNA analysis, DNA collection products, and research services to law enforcement agencies, governments, crime labs, and disaster management organizations throughout the United States and around the world.

Bode is committed to quality and its forensic DNA services are accredited to four laboratory standards: ASCLD/LAB, New York State Department of Health (for Forensic Identity), FBI (for Forensic and Convicted Offender DNA Testing Labs), and ISO/IEC 17025.

While Bode uses its own software solution (Bode Technology’s Laboratory Information Management System – Bode-LIMS) for tracking samples through the lab, it turned to Qualtrax Compliance Software to organize and maintain its quality management system. The document control functionality of Qualtrax was particularly attractive to the Quality Assurance department as it sought a streamlined way to meet the requirements set by all applicable forensics standards.

Taking Control of Documents and Records

Understanding the importance of document control, Bode initially hired Amanda Thomas as a quality assurance coordinator with responsibility for implementing and managing the Qualtrax system.

“Before Qualtrax, it was very difficult to know which documents were current,” says Ms. Thomas, who is currently the Quality Assurance Supervisor at Bode. “Now, everything is secure, organized, and up-to-date.”

In the early stages, Bode focused on updating and importing all of the lab’s standard operating procedures (SOPs). It then expanded the scope to include training records, quality control policies, laboratory worksheets, and audit documentation.

“We are now looking to add validation records and equipment logs,” Ms. Thomas explains.

Bode also uses the Qualtrax workflow feature to create records. In order to maintain compliance with the FBI Quality Assurance Standards, analysts must read relevant scientific articles throughout the year and attend continuing education activities. Bode’s “Scientific Literature Review” and “Continuing Education” workflows allow analysts to quickly record what they have read, what conferences they attended, and post a short summary or attach certificates as proof. Completed workflows are then saved as .html files and imported using the document control functionality under each analyst’s training folder, and can be searched in the event of an audit or in order to identify any missing submissions.

Saving Time (and Time is Money)

“The amount of time Qualtrax saves us is how we measure return on investment,” says Ms. Thomas. “Employee training, annual procedural reviews, and audits are all quicker using Qualtrax.”

  • Employee training – There is less of a “learning curve” because employees can go straight to Qualtrax to find the most current versions of the information they need.
  • Annual procedural reviews – All laboratory procedures must be reviewed by the technical leader each year. The audit trails in Qualtrax make this easy to verify, as well as the expiration feature and the ability to verify that an expired version is up-to-date. This provides the option to review and add any comments without having to edit the document.
  • Audits – Ms. Thomas says that auditors are sometimes skeptical of the software-based approach to quality management. Standard practice required Bode to prepare binders of information through which the auditors searched for necessary documentation. She assures, “They always find it takes less time with Qualtrax because they don’t have to ask where everything is.” She is also pleased that they usually only have positive things to say about using Qualtrax upon completion of the audit.

Putting its Best Foot Forward

Since Bode is a private lab, FBI standards require that clients often perform their own quality reviews during site visits.

“With Qualtrax, we get to show clients a more professional face,” says Ms. Thomas. “Everything they would need to review is stored in one place, so prep work is minimal. We have even had a client inquire about using Qualtrax in their facility!”

As Bode grows its system, employees notice the value Qualtrax adds.

“People are now asking, ‘Can I do this in Qualtrax?’ or ‘Can I find that in Qualtrax?’ My goal is to eventually include everything that a client or auditor would want or need to see.”

Seeing is Believing

Having worked with Bode’s Qualtrax system from the beginning, Ms. Thomas has seen its effects on the lab.

When asked what she would tell other laboratories evaluating Qualtrax, she quickly replied, “I wouldn’t tell them. I would show them.”