Data Management

Data management is a collaborative effort involving multiple persons or organizations with differing knowledge, experience, tools, and scope of responsibility within your project.  Even with conscientious efforts, errors in the data may occur as data is passed from one person or group to another, in some cases rendering complete sets of data unusable.

Data can not be managed if it is not documented.  Documentation is useful for communication within and between responsible groups, and over time.  Without adequate documentation, individuals with best intentions can make different assumptions about the data.

When data management problems crop up, hardworking people are tempted to work harder on what they know.  However, the solution is often to focus on documenting the data to communicate it between specialists.  A preproduction document control system can simplify the documentation process by striking a reasonable balance between the freedom for technology exploration and the requirements of FDA regulations.  (See A Tale of Two Document Control Systems.)

We can identify core competency data that should be documented and controlled for archive and use, then propose and implement documentation methods for your environment including data encoding and disambiguation.

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