The MHRA published a guideline for industry for the integrity of GMP data. This guideline applies to the pharma and medical device industries. This is a great guideline to use to update your SOP on Recording CGMP data. If you don’t have such an SOP, now is the time to develop one. Both the FDA and EMA will be looking at your data integrity expectations and practices.
For example, you need to train personnel on the expectation that data (Information derived or obtained from raw data (e.g., a reported analytical result) will comply with the following (ALCOA):
Attributable: The identity of the person who made the entry must be unique and obvious and the date when the entry was made must be included.
Legible: Readable and able to identify the person who generated the record.
Contemporaneous: The information must be documented in the correct time frame along with the flow of events. Chronology must be apparent. Any delays must be explained.
Original: The original data must preserve data accuracy, completeness, contents and meaning, including the meta data. If not original, then it should be an exact copy, signed and dated by the person who made the entry.
Accurate: Accurate, consistent and real representation of facts
Some people don’t know what raw data is: Original records and documentation, retained in the format in which they were originally generated (i.e. paper or electronic), or as a ‘true copy’. Raw data must be contemporaneously and accurately recorded by permanent means. In the case of basic electronic equipment which does not store electronic data, or provides only a printed data output (e.g., balance or pH meter), the printout constitutes the raw data.
While we are on the subject of data integrity, you should also have an SOP on Scientific Integrity. It should be a company policy whereby Senior Management communicates their position on scientific conduct and ethics. This is a key SOP that a lot of companies don’t have.
We have seen scientific integrity issues at NIH, in Japan and many other sites and countries. These occurrences are what has triggered both FDA and the EMA to focus more on data integrity during routine and PAI inspections.
Download the guidance here.