When we say that data must be “contemporaneous,” we mean that it must be recorded at the time the event happens.
When thinking about data being contemporaneous, the most important thing to remember is that data can never be created and documented prior to it actually being generated.
Pre-Loading
This is also known as “pre-loading”, or as health authorities would call it, falsifying.
Information such as batch number, sample identity, stability storage location and condition, or any other pertinent information must be documented at the time of analysis or process in order to prevent any possibility of a mix up.
Health Authority Audits
During health authority audits inspectors will often evaluate a company by verifying time stamps and date stamps, and then cross referencing them to ensure employees were present on the day an item was signed for.
To explain this in simpler terms, people in most practical scenarios cannot write what they are doing and do what they are doing at the same time. Physically, it is not possible to do this.
The worst-case scenario is for them to write what they are going to do before they have done it.
Employees should never pre-load data into any type of record. You cannot document the data until after you acquire the data.
Falsifying
This again is what health authorities would refer to as falsifying or making it up.
If dates appear before activities happen, inspectors will immediately recognize this and assume data is being falsified.
Real Time
To reiterate, you cannot record that something was done before you actually do it, therefore you must record it immediately after you do it. This is referred to as documenting in “real time,” which is immediately after an act is performed.
You might wonder what is meant by “immediately.” This depends on what’s practical. “Immediate” may be one second, one minute or one hour, depending on the process or activity being performed.
However, employees should not be waiting days to document data.
Close as Possible
Recording needs to be as proximally close to the activity as possible. It should not take an exceptionally long period of time and it must not happen before the event occurs.