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Logistical Challenges in GXP Inspections: Staging Documents

No two inspection teams organize logistics in the same way.  Roles, responsibilities, number of team members, tools, even the terminology for the rooms in which the participants sit (War Room?  Situation Room?  Ready Room?) –every team has its favored approach. We’ve worked with teams whose every move was highly choreographed and teams who started with a loose idea of logistics and evolved as they went along.  We’ve seen teams work 18-hour days and teams that roll up to the office just in advance of the inspector.

Inspection logistics develop in specific response to inspection challenges.  Although the responses are unique, the challenges are not.   This week, we’re going to focus on common challenges and how teams respond to them.  First up:  staging documents.

Staging refers to the process of preparing documents in advance that the inspector will likely request.  “Preparing” usually means copying (either paper to paper, electronic to paper, or electronic to electronic) and then holding those copies in an easily-accessible location so they can be retrieved quickly when asked for.  (Preparation can also involve redacting documents with financial information, like contracts.) The main advantage of staging is that you can deliver these requests quickly, freeing the team’s time to work on more difficult requests. The risks are twofold:  First, documents staged too far in advance can get “out of synch” with the originals that are being updated in their authorized repositories. Second, and more importantly, the team may waste time staging documents that are never requested while being stymied by requests

As a rule, we recommend staging documents only in these cases:

Documents almost certain to be requested.  Slide decks that provide an overview of the study, a high-level organizational chart, SOPs relevant to the inspection scope, most recent plans and specifications within the scope of the inspection, and any documents specifically suggested by an agenda provided in advance should be ready to deliver.  It will start the inspection off on the right foot if the inspector’s early requests are delivered promptly.

Master lists. It can be helpful to generate a comprehensive report including information that is likely to be requested – for example, an inventory of all quality processes, forms, and templates, with various metadata that allows them to be sorted and filtered easily – prior to an inspection.  The inspector will almost certainly request a subset of this data during the inspection, and it will be easier for the team to winnow down a pre-reviewed export than to generate the data upon request.

Documents that are difficult to retrieve because of how or where they are stored.  For example, let’s say a team has used three different systems for capturing training records over the life of a study:  a paper system, e-signatures within a Quality Management System, and then a Learning Management System.  It may be easier to compile training records of key team members, even if some of those records are never requested, rather than attempt to compile those records upon request.  In another example, documents related to a complex issue that are stored in various places of the Trial Master File might be gathered in advance.

With that said, however, the feedback we hear most frequently from our Ready Room customers when we ask, “How did the inspection go?” is “We staged too much.”  Trial Master Files can include anywhere between 5,000 and 30,000 documents; a company can have hundreds of quality process documents; and trying to guess which ones the inspector will request can be like predicting the location of a needle in a haystack.  Well-organized documents and a well-trained team obviate the need for extensive staging.

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