Data Integrity Compliance for Paper Forms and Electronic Data Created in Regulated Laboratories and Manufacturing – Where Forms are Used Today in Regulated GxP Environments
Guest Author: Heather Longden
Ms. Heather Longden has thirty (30) years of experience in regulatory compliance in the pharmaceutical industry and is an expert in data integrity, data management, 21 CFR Part 11, GxPs, and computer system validation. She is a leader at the GAMP® Americas Steering Committee and serves on the the ISPE Boston Area Chapter Board and Education Program Committee (EPC).
In this moths blog, I will dive deeper into why and where paper/printed forms are still used in Pharma manufacturing and testing facilities who are purporting to meet regulatory GxP requirements.
But first, a couple of definitions and notes. In most cases, I will be referring to forms that are printed, completed in pen, and then stored as paper records. However, when those forms are then scanned and stored electronically as PDF files, I will still refer to them as paper forms, regardless of the format of the archived ‘copy’.
Forms issued, completed AND stored electronically will be discussed later, as they generally have their own compliance requirements to address.
Good documentation practice is essential for all records required by a regulatory predicate rule. Some companies still refer to this as GDP, however, since the introduction of Good Distribution Practice, which claimed the GDP acronym, documentation regulations now use the term GDocP.
Where are Printed Forms still in use?
Printed forms, as I mentioned in my previous blog(1) can be found across the pharmaceutical industry. While my experience is mostly related to laboratory environments, I have put together a wider picture that encompasses the clinical and manufacturing spaces, where GDocP is still expected.
Logbooks for Instruments / Equipment
Probably the most widely profligate kind of printed form you will find are logbooks for lab instruments or equipment. These include, but are not limited to, major pieces of lab or manufacturing equipment, equipment to provide pure water, gas supplies, control equipment for temperature and/or humidity, simple lab devices such as pipettes or balances, or complex analytical equipment, for example HPLC or mass spectrometers.
Log books typically are used to record, at a minimum, installation, upgrade and maintenance activities, calibration, qualification or other kinds of equipment performance checks, and, ideally, a record of products or procedures that the equipment is used for. These records are essential to the quality of the product they are supporting, and are indispensable for troubleshooting anomalous issues.
Few pieces of equipment, even highly automated ones, will have software that can automatically record, to GDocP and ALCOA+ requirements, activities that are expected in a logbook. Even if a few do, the chances that these electronic records can be preserved and collated between the wide array of equipment types and manufacturers, are slim to none.
Printed documents, therefore, become the de facto way to standardise record keeping needed to meet log book requirements.
Forms Documenting Human Activity
Printed forms are also widely used to document human activity, whether in the manufacturing or testing facility, but also at many points in the clinical process. Specifically forms that “require’ a signature or approval will typically be presented to the person to sign with a pen.
This practice spans from clinical trial recruitment, questionnaires and surveys, through supply chains contracts and delivery, to record keeping in the manufacturing process, documentation of manual laboratory procedures, and documenting packaging and warehouse activities, all forQuality Assurance review and approval.
While purchasing, packaging, distribution and warehousing have been largely digitised, and thus able to capture attributable actions contemporaneously with the need for ‘a human with a pen’, this is not true throughout the pharmaceutical development and production lifecycle.
Sometimes, even when fully electronic solutions are possible, the effort of transforming away from printed forms may cause reluctance, especially when the printed form approach is easy and simple, and appears to meet the GDocP requirements.
Be wary of excuses that ‘this process requires a ‘signature’ for regulatory purposes, as a sign of reluctance to digitise. The predicate rules are usually clear about when a signature is actually required, however, many processes developed in a paper world leveraged signatures as a mechanism to assign attributability to actions. For instance, if today’s paper process requires a signature to record that a specific ‘step has been done’, it was probably written that way as the ONLY way an action could be attributed to a specific individual without unique log in capabilities.
Forms Documenting Equipment Readings
This category of printed records is perhaps the easiest group to address in the 21st century. While I do not doubt that there may be a few non-smart pieces of equipment throughout a regulated life science company (I really don’t believe that much manual dispensing of liquids or bursted pipetting is done today), almost every instrument or monitoring tool can now be digitised.
Acceptance of bluetooth and wireless data connection has demolished the need to ‘wire everything up to computers’ and most pieces of equipment will already be furnished with its own computerised system for control purposes, and will almost certainly have the capability to record and transmit readings to a secure permanent location, rather than storing original record data on RAM chips or hard disks. Ignoring that capability and asking a human to write down numbers is not only a waste of time, but also prone to human error in both the recording step, and then transcribing it into other systems such as ERP/MES/LIMS/LMS P, for ‘further’ record creation.
Some equipment may actually only have a ‘print out’ capability for readings. In this case, that printout must be preserved as the original record, regardless of any transcription into a form. However, be careful that the printout must be a true, accurate and complete copy of every piece of data and information known to the measuring equipment /instrument, and cannot ‘lose’ any data nor any ability to ‘interact’ with the data that was possible directly via the console, for example.
One objection I have often heard is about the ‘environment’ which is ‘not conducive to using a computer or tablet device’. This might be true to record truly manual readings, such as the level in a filled vessel, but generally, those manual ‘recordings’ have already been computerised, so it is just case of investing in the complete digital journey of reading electronically.
If you examine your regulated environments for the use of printed forms, you may likely be surprised by the number and volume of paper forms still being used, and the sheer manpower and time expended in maintaining them. This could be for any number of reasons:
- Printed forms have always been used and “nobody likes change, especially the regulators”
- Too much effort to redesign the form digitally and train everyone on the new design.
- The process was overlooked for digital transformation.
- There is a regulatory reason, such as a signature, that requires a printed form.
- The workflow required for the form would be difficult to automate.
- There is a believe that once you convert it to PDF , its not a paper form anymore.
- It would cost too much to digitise and integrate that form
- They are the only way to make that record
- It is easier to use a printed form and complete with a pen
- The rest of your process relies on that printed form
- You can’t use a computer or tablet in that environment
To continue learning how to remove these bottlenecks and implement a Form Management System that can import your existing forms with no re-design required, and is easy to deploy, validate and use, follow this blog series, visit part11solutions.com, or email CIMCON at firstname.lastname@example.org.