A guide to data integrity in pharmaceutical environmental monitoring

03 August 2022

Data integrity is fundamental in highly regulated industries such as pharmaceutical manufacturing, to ensure products are of the required quality.

With the number of warning letters and statements of non-compliance with GMP citing data integrity alone having tripled since 2013, re-gaining trust in data is a priority for many pharmaceutical manufacturing facilities.

Data integrity guidelines

The ALCOA+ framework, originally introduced by the FDA in the 1990s, is used by leading regulatory bodies worldwide. The acronym stands for:

Attributable: all data must be identified to the person or system from which it was generated or collected, as well as the time of data collection. Alterations to the data should also be annotated clearly with the same information.

Legible: data should be easy to read, understandable and permanent. It should not be possible to alter data without an audit trail preserving the original record.

Contemporaneous: the time of data collection should accurately correspond with the time in which the data was recorded – whether for original records or later corrections.

Original: original records should be preserved rather than relying on copies.

Accurate: data should be free from errors, truthful, complete and reflect reality.

The following principles were later additions to the guidance, represented by the + symbol:

Complete: all data must be present, with no omission or deletion of data. This can be ensured using a robust audit trail to show no information has been lost or deleted, and any amendments to the original data set are visible.

Consistent: data should be chronological with timestamps for amends to the original records.

Enduring: data should be safely stored in a manner which will be available long after it is recorded.

Available: data must be accessible when needed.

Breaching even one of these principles could lead to a lack of trust in your data. If you can’t trust your data, how do you know for sure your products are safe?

Risk factors

Reading through each principle, you may start to see for yourself where, despite your best efforts, processes in your facility fail to meet the criteria.

Strict regulation often leads to increased data capture, with the requirement to analyse this data and understand what it means. Often, this data is not analysed, with trends in sub-limit monitoring results often going undetected. Much of this data is still collected using paper records and analysed on spreadsheets.

However, paper records aren’t enduring or legible, as they are easily lost or destroyed. Re-transcription means the original record isn’t used for trending. Misfiling original records or transcribing data in a different order to which data was processed could mean records aren’t contemporaneous or consistent. Delays in transcription or crashing spreadsheets could impact the availability of records. Audit trails are challenging to create on spreadsheets, without which, data isn’t complete. Multiple transcription stages increase risk of human error, impacting accuracy.

See how every single ALCOA+ principle has been broken in this example, through using paper and spreadsheets? Even if a LIMS or other legacy system is used, many of these issues remain – for example, by not using the original record.

Data integrity challenges can also be introduced by your personnel. For example, in the colony counting process, errors can creep in as the day progresses and operators tire. In this instance, you could ensure second checks are carried out; however, this is resource-intensive and still subjective. Likewise, the process to prepare standards and samples for endotoxin testing is long and prone to human error, leading to a lack of confidence.

Consequences of breaching data integrity guidelines

Internally, teams such as Quality Control may be seen by the wider business as lacking value. Limited insight and responsiveness to the business needs due to information not being readily available contributes to this view, resulting in pressure from senior executives to enhance performance.

In fact, in 2020, as many as 39% of Quality Professionals named economic performance as their main goal – even above compliance. This shows how pressure, likely from other teams within the company, is shifting priorities within these departments. Whilst economic performance could be a side effect of efficient procedures and a job well done, it isn’t necessarily what QC is for – whereas ensuring compliance is.

Externally, consequences may be more severe. As regulations tighten, facilities not meeting data integrity guidelines face increasing external scrutiny, heavy fines and in some cases, temporary or permanent suspension of manufacturing licenses.

Ultimately though, consequences could stretch far beyond impact to business; an inability to trust data means that patient safety may be at risk. In extreme circumstances, contamination could result in a patient becoming seriously ill, or even death. Minimising errors and risks are therefore of upmost importance.

How to improve data integrity in environmental monitoring

Digitalising your data will help you overcome the first risk factor of using paper and spreadsheets in your facility. Let’s use the example of environmental monitoring – a process that uses significant volumes of paper.

Dedicated environmental monitoring software, SmartControl EM, was built in line with FDA 21 CFR Part 11 and EU GMP Annex 11 to help you meet regulation, enhance data integrity, and take better environmental monitoring decisions.

Rather than recording data onto paper, you can enter it directly into SmartControl EM. The original record will therefore be used for any trending and analysis. All data is stored contemporaneously and instantly available in the cloud, with no need to re-transcribe data at any stage. This improves the accuracy of your records.

At the time of data collection and for any subsequent changes,SmartControl EM will record information such as the name of the Operator, date, and time of the record as part of a complete audit trail – meaning data is attributable, consistent, enduring and legible. That’s all the ALCOA+ principles met, allowing you to re-gain confidence and trust in your data.

When it comes to the second risk factor, being human error, there are ways to use technology and automations to benefit your data integrity.

For colony counting, there are a range of automated colony counters on the market that can be used as a first or second check. Unlike humans, colony counters can provide you with consistently accurate, repeatable results.

Whilst many colony counters have a way to go when it comes to counting complex samples, Microgenetics have created SmartControl Colony Counter, which can even process environmental monitoring samples.

Using Machine Learning, the SmartControl Colony Counter can learn the difference between colonies and background noise, so it can count colonies using the same criteria as a human would – but it doesn’t tire. As a result, you can be certain that your data is objective and accurate.

Automation also has a place in improving data integrity for pharmaceutical manufacturers. A pillar of Industry 4.0, automation is of growing importance – particularly in labs with a high throughput – since it can reduce workloads, improve efficiency, and give you confidence in your data.

Using the example of endotoxin testing, automation of the preparation steps allows the process to be streamlined, reducing the risk of contamination. By minimising human error, you can be sure of the accuracy of your data, hence improved data integrity.

Summary

  • ALCOA+ principles are leading data integrity guidelines, used by the FDA and MHRA
  • Breaching any principles could lead to a lack of trust in your data
  • Paper and spreadsheets in your environmental monitoring facility could be compromising your data integrity
  • Digitalising your data using software like SmartControl EM can minimise this risk
  • Manual processes also open your facility up to human error. For example, colony counting. Technology can benefit you here too

Learn more about Microgenetics technology

SmartControl EM

SmartControl Colony Counter

SwiftDetect rapid test 

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