Document Reviews Are Key Part of QMS for Sites, Expert Says

Clinical trial sites developing a quality management system must ensure there is a review cycle for documents and procedures so they don’t become stagnant, an expert advises.

This review cycle can be annual or biannual, says Susan Leister, director of quality assurance for Technical Resources International, but is important because the performance level of a process tends to decrease over time if there is no routine maintenance.

In particular, procedures or documents that have not been updated in two years or more should put it through a review where the process owner, department manager or document owner makes sure nothing is outdated. Potentially outdated elements could include references to regulations or content based on regulations, Leister says. She spoke during a recent FDAnews webinar.

Leister stresses that it’s important for sites to document that they conducted this type of review. It’s also important to ensure version control and to archive the older versions of the procedures. Requirements for those activities should be included in the review procedure.

Leister recommends that sites maintain a revision history in their standard operating procedure template. This should capture each update to the document and can list them in bullet points.

Change Control

There should also be a change control procedure, outlining steps for updating a procedure, Leister says. This procedure should address version control and related items, such as ensuring there is only one document on any topic in effect at a given time. It should also spell out who will issue the template and whether the site will use a paper or an electronic system.

Most companies will have uncontrolled documents, Leister notes. “But you need to define the difference between them and, again, where you’re storing them. You want to make sure that these things are secure. … Establish the processes behind that.”

While document formatting may seem like a minor issue, sites should also make sure they have an SOP on that. This should define how the site will prepare a procedure, including the various sections of the procedure, Leister explains.There should be consistency in document formatting throughout the organization, such as using the same font size throughout.

It may not seem very important, but if an auditor sees that different employees are doing things differently, “it sets the tone of, ‘hmm, if they can’t even get that consistent, then what else are they not able to do,’” Leister warns. “So, those little things can make a big difference.”

When establishing a corrective and preventive action program, Leister encourages a risk-based approach with the creation of at least three CAPA categories — critical, major and minor. “You want to be able to filter and prioritize your CAPAs,” she says.

Sites should also establish thresholds or action levels, such as specifying how long a system can be down. If that level is reached or exceeded, the issue should be pushed into the CAPA program.

But while some companies “run on the philosophy of putting every problem into a CAPA program,” Leister advises against doing that. “You don’t want to overload your CAPA program,” she says.

Training programs are another key consideration for a good quality management system, as inspectors may ask how the site ensures employees are qualified, particularly for principal investigators. Factors to consider include education, certifications, experience, training and skills.

Training Matrix

The training program should specify the level of competence for each job position, Leister says. A training matrix allows the auditor to easily examine the training file and verify that the person complete the required trainings. “You want to make things easy for an inspector. You want them in and out of your facility,” she adds.

The current and future needs of the training program should be considered as well, such as cross-training needs and documentation procedures. Leister notes that many companies set a timeframe for how frequently they want staff to receive GCP training.

There should also be a specified frequency for competency assessments, including how the site documents that staff are reading SOPs or that they have attended conferences, webinars or new employee training. Documentation could be a basic template that is signed by the person who has conducted or verified the training.

Finally, employee training folders should include a job description, a resume or CV, training documentation, evidence of SOP readings or other work instructions and any other training documentation and certificates, Leister says. — April Hollis



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