Data Integrity and Control of Forms

In “Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry” the FDA states the following about control of blank forms:

There must be document controls in place to assure product quality (see §§ 211.100, 211.160(a),211.186, 212.20(d), and 212.60(g)). For example, bound paginated notebooks, stamped for official use by a document control group, provide good document control because they allow easy detection of unofficial notebooks as well as any gaps in notebook pages. If used, blank forms (e.g., electronic worksheets, laboratory notebooks, and MPCRs) should be controlled by the quality unit or by another document control method. As appropriate, numbered sets of blank forms may be issued and should be reconciled upon completion of all issued forms. Incomplete or erroneous forms should be kept as part of the permanent record along with written justification for their replacement (see, e.g., §§ 211.192, 211.194, 212.50(a), and 212.70(f)(1)(vi)). All data required to recreate a CGMP activity should be maintained as part of the complete record.

6. How should blank forms be controlled? on page 7 of 13

First sentence “There must be document controls in place to assure product quality” should be interpreted in a risk based approach. All forms should always be published from a controlled manner, ideally an electronic system that ensures the correct version is used and provides a time/date stamp of when the form is published. Some forms (based on risk) should be published in such a way that contemporaneity and originality are more easy to prove. In other words, bind them.

A good rule of thumb for binding a printed form (which is now going to become a record) is as follows:

  1. Is it one large form with individual pages contributing to the whole record that could be easily lost, misplaced or even intentionally altered? 
  2. Is it a form that provides chronological order to the same or similar pieces of information such as a logbook?
  3. Is time of entry important?
  4. Will this form live with a piece of equipment, an instrument, a room for a period of time? Another way to phrase this, if the form is not a once and done that upon completion as a record moves along in a review flow.

If you answer yes to any of these, then the default should be to bind it and control it through a central publishing function, traditionally called document control.

The PIC/S draft on data integrity has more to say here:

Reference Expectation Potential risk of not meeting
expectations/items to be
Distribution and Control Item 2 page 17 of 52 Issue should be controlled by written procedures that include the following controls:
–  Details of who issued the copies and when they were issued.
– using of a secure stamp, or paper colour code not available in the working areas or another appropriate system.
– ensuring that only the current approved version is available for use. – allocating a unique identifier to each blank document issued and recording the issue of each document in a register.  
– Numbering every distributed copy (e.g.: copy 2 of 2) and sequential numbering of issued pages in bound books.   Where the re-issue of additional copies of the blank template is necessary, a controlled process regarding re-issue should be followed. All distributed copies should be maintained and a justification and approval for the need of an extra copy should be recorded, e.g.: “the original template record was damaged”. – All issued records should be reconciled following use to ensure the accuracy and completeness of records.
Without the use of security measures, there is a risk that rewriting or falsification of data may be made after photocopying or scanning the template record (which gives the user another template copy to use). Obsolete version can be used intentionally or by error. A filled record with an anomalous data entry could be replaced by a new rewritten template.   All unused forms should be accounted for, and either defaced and destroyed, or returned for secure filing.

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