Data Integrity for Record Management

Last night speaking at the DFW Audit SIG one of the topics I wished I had gone a little deeper on were controls, and how to gauge their strength.

As I am preparing to interview candidates for a records management position, I thought I would flesh out controls specific to the storage of and access to completed or archived paper records, such as forms, as an example.

These controls are applied at the record or system level and are meant to prevent a potential data integrity issue from occurring.

Generation and Reconciliation of Documents

 Data Criticality
Unique identifierFor each recordNoNo
Who performs controlled issuanceIndividuals authorized by quality unit from designated unit (limited, centralized)Individuals authorized by quality unit from (limited, decentralized)Anyone (unlimited, decrentalized), often user of record
ReconciliationFull reconciliation of record and pages based on unique identifierFull reconciliation of records and pages based on quantity issuedNo reconciliation
Controlled printYesYesNo
Bulk printingNoYes, by controlled processYes
Destruction of blank formsPerformed by issuing unit, quality oversight required (High level of evidence)Performed by the operating or issuing unit, quality unit oversight requiredPerformed by the individual, quality unit oversight required (periodic walk throughs, self-inspections and audits)

Storage and Access to completed and archived paper records

 Data Criticality
Where StoredClimate-controlled roomClimate-controlled roomOffice retention location
How Removed & ReturnedLimited conditions for removal (e.g. regulatory inspections) method of recording the removal and return of the record(e.g. archive management system, logbook). Most use of documents either in controlled reading area or by scans.Method of recording the removal and return of the record(e.g., archive management system, logbook).Method (e.g. logbook) recording of documents checked-in/checked-out
Access ControlCard key access with entry and exit documented.Card key access with entry and exit documented.Limited key access
Periodic User Access ReviewAnnuallyAnnuallyEvery 2 years

There are also the need to consider controls for paper to electronic, electronic to paper and my favorite beast, the true copy.

For paper records a true copy of a picture of the original that keeps everything – a scan. The regulations state that you can get rid of the paper if you have a true copy. Many things called a true copy are probably not a true copy, to ensure an accurate true copy add two more controls.

 Data Criticality
Review requirementsDocumented review by second person from the quality unit for legibility, accuracy, and completenessDocumented review by second person (not necessarily from the quality unit) for legibility, accuracy, and completenessDocumented verification by person performing the scan for legibility, accuracy, and completeness
Discard of original allowedYes, as defined by quality unit oversight, unless there is a seal, watermark, or other identifier that can’t be accurately reproduced electronically.Yes, performed by the operating unit, unless there is a seal, watermark, or other identifier that can’t be accurately reproduced electronically. Quality unit oversight requiredYes, individual can discard original Quality unit oversight required

PDF fillable forms

On the following question was asked “The Device History Record is a form in fillable PDF format. Worker opens the PDF from a secure source within the local network. The only thing they can change is checkmark Pass/Fail, Yes/No and enter serial numbers in the allowed fields. Then after the assembly process is done for each procedure, the worker prints the DHR, signs and dates it by hand, to verify the accuracy of data entered. No re-printing or saving PDF’s is allowed.”

This comes up a lot. This is really a simple version of a hybrid situation, where both electronic and paper versions of the record exists.

Turning to the PIC/S draft guidance we find on page 44 of 52 “Each element of the hybrid system should be qualified and controlled in accordance with the guidance relating to manual and computerised systems”

Here would be my recommendation (and its one tried and tested).

The pdf form needs to be under the same document management system and controls as any other form. Ideally the exact same system. This provides version control and change management to the form. It also allows users to know they have the current version at all times.

Once it is printed, the paper version is the record. It has a wet-signature and it under all the same predicate record requirements. This record gets archived appropriately.

Where I have seen companies get messed up here is when the pdf exists in a separate, usually poorly controlled system from the rest of your document management. Situations like this should really be evaluated from the document management perspective and not the computer systems life-cycle perspective. But its all data integrity.

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.

Forms, forms, everywhere

Unless you work in the factory of the future the chances are you have forms — if you are like me over 1100 of them. So what is a form and how does it fit into our document management system?

Merriam-Webster Dictionary defines form (amongst other things) as “a printed or typed document with blank spaces for insertion of required or requested information.”

We use forms to tell what information needs to be captured, and usually to record when and by whom. Forms have the following advantages in our document management system:

  • The user has to write less
  • The user is told or reminded what information has to be supplied
  • There is uniformity
  • Information is collected in writing and so can be reexamined later. Forms almost always have a signature field to allow someone to take responsibility

It is useful to note here that electronic systems do basically the same thing.

Returning to our three major types of documents:

  • Functional Documents provide instructions so people can perform tasks and make decisions safely effectively, compliantly and consistently. This usually includes things like procedures, process instructions, protocols, methods and specifications. Many of these need some sort of training decision. Functional documents should involve a process to ensure they are up-to-date, especially in relation to current practices and relevant standards (periodic review)
  • Records provide evidence that actions were taken and decisions were made in keeping with procedures. This includes batch manufacturing records, logbooks and laboratory data sheets and notebooks. Records are a popular target for electronic alternatives.
  • Reports provide specific information on a particular topic on a formal, standardized way. Reports may include data summaries, findings and actions to be taken.

A form is a functional document that once printed and has data entered onto it becomes a record. That record then needs to be managed and has all sorts of good documentation and data integrity concerns including traceability and retention (archiving).

It is helpful here to also differentiate between a template and a form. A template is a form that is specifically used to build another document — an SOP template or a protocol template for example. Usually the template gives you a document that then goes through its own lifecycle.