A paper-free strategy for quality control

1 April 2018

Traditional microbiology labs in the pharmaceutical industry have relied on the use of paper-based record-keeping for environmental monitoring of the workplace for many years. With some labs processing thousands of environmental samples each day, this leads to the production of huge amounts of paperwork, which all needs to be printed out, written up, physically stored, and often entered into a corresponding electronic transcript.

This is a time-consuming and costly process in terms of both resources and effort, not to mention the number of trees which have been sacrificed along the way! As the industry expands and the volume of records which need to be kept increases year on year, it is time we started to look at more practical and future-proof methods of record-keeping.

Converting your lab to an entirely paperless system has many benefits, including:

  • Increased efficiency in the lab
  • No need to designate physical space to store paper records which in many cases are required to be kept for a number of years
  • Easier to store data securely indefinitely
  • Easier to police data integrity, with the introduction of user monitoring and automatic tracking of when data is entered and by whom
  • Prevents records being lost or mislaid
  • Easier to keep in line with the principles of ALCOA – attributable, legible, contemporaneous, original and accurate record-keeping
  • Records can also be designed to be complete, consistent and enduring in electronic form
  • Maintenance of an easily accessible audit trail
  • Ability to track records and examine data trends over time, which is useful to many companies in evaluating performance
  • Bigger return on investment
  • For example, Mike Stroz, a Global QC Systems program manager at Global Operations IS stated that this company had a 30-40% gain in resources as a direct result of transitioning to a paperless system (read more).
  • So if there are so many benefits to converting to a paperless system, why are so few labs making use of them?

    Despite these advantages, most labs are reluctant to transition to electronic record-keeping because it would in many cases require a complete overhaul of their current system. Paper records are so deeply embedded in the culture of microbiology labs that it will require a significant shift in attitudes before paperless systems are fully embraced. For example; current personnel will need to be re-trained to use new software, and appropriate training procedures will need to be designed for any new staff who are hired after the introduction of the new system; it is known that paper-based systems are accepted by regulatory agencies, and the idea of switching to a paperless system brings with it a degree of uncertainty/apprehension in fulfilling regulatory requirements; and furthermore, there are a daunting number of electronic systems on offer to microbiology labs which are all produced to different standards, and choosing the best option for current and future record keeping can be a difficult task.

    However, as more focus is put on the development and implementation of paperless systems, these problems are being addressed. For instance, while it has been thought that regulatory agencies prefer a paper trail, the FDA rule 21 CFR Part 11 states “paper records to be equivalent to electronic records, and electronic signatures equivalent to traditional handwritten signatures”, a consideration which came into effect in 1997.

    Developers are also recognising the need for more intuitive software, which is simple, affordable and most importantly, user-friendly. Possibly the biggest barrier to labs making the transition to paperless systems is how complicated the transition to an electronic system is perceived to be, along with the attitude that if a paper system works why is there a need to change it? For paperless record-keeping to really take off in microbiology labs, software needs to be developed which is as flexible and easy to use as paper-based systems, if not more so. This will lead to the change in attitudes and culture which is needed for labs to move forward.