Digitalisation of Environmental Monitoring Data

18 June 2021

The pharmaceutical manufacturing industry, especially environmental monitoring departments, utilise copious amounts of information and data. There has recently been a shift in focus towards getting more value from data, understanding that automated systems and trend analysis are key factors in gaining confidence in your data.

Pharma 4.0 incorporates some of the key concepts of Industry 4.0, allowing manufacturers to automate systems. In turn, this helps facilities to meet regulations, enhance data integrity and take better environmental monitoring decisions.

Digitalisation of data

Environmental monitoring departments use significant volumes of paper, from recording monitoring procedures and results, to logging actions and generating batch records. Paper records can easily be lost, damaged or illegible, presenting significant data integrity challenges. It is often unclear who data is attributable to and requires transcription to a system like Excel - which leads to further data integrity challenges - before analysis can occur.

If some of this data can instead be stored digitally, the requirement for paper records is reduced significantly. This can begin to help address some of the data integrity issues found with paper-based recording of data.

Smart solutions can, when correctly implemented, help to ensure compliance with the ALCOA+ principles: data can be stored contemporaneously and accurately, in a clear (legible), original and attributable manner with full audit trails, ensuring that it is stored in a consistent, accessible, enduring format.

How can this approach be applied to pharmaceutical data?

There is often significant duplication of data within the pharmaceutical industry; results and information may be recorded on a paper-based worksheet system, only to be transcribed at a later date to further paper-based systems, legacy data recording databases or Excel spreadsheets for data analysis. This presents further data integrity challenges to companies, with the possibility of transcription errors, or alterations to data leading to a lack of confidence in the data.

Next generation data storage systems such as SmartControl can help to minimise these issues, storing all data in one place, minimising transcription, and can pull relevant data into simple, easy to understand formats. Data can be input directly into these systems and stored in a compliant, auditable manner, allowing companies to have greater confidence in their data.

With paper-based systems, errors in processing or transcription are often caught too late in the process – possibly even following completion of manufacture during documentation review. Digital solutions allow these mistakes to be caught in real-time – documentation review can occur contemporaneously throughout processes.

Getting more from your data

Inputting and understanding data in legacy databases and Excel spreadsheets commonly used for storage and analysis of environmental monitoring results can be difficult and time-consuming. Data must be pulled from many different locations to generate graphs and reports, and this is often performed manually, relying on data having been transcribed correctly to ensure reports are accurate and up to date.

Environmental monitoring systems such as SmartControl can help to minimise these issues, storing all data in one place, minimising transcription, and can pull relevant data into simple, easy to understand formats. This allows users to get more from their environmental monitoring data. Analysis is made easy, but these systems can also provide other functions such as scheduling tools and live electronic logbooks and batch records.

With paper-based and legacy data storage systems, it is often difficult to consider whole facilities and data. Environmental monitoring data in isolation does not provide a clear picture of the state of environmental control of a facility; however, an overview provided by digital data allows a much more robust picture to be developed.

Trends of environmental monitoring data must also be considered to create this clear picture of the state of environmental control of the facility. A single result, or a small group of results, may not provide a clear picture of the state of the environment. The easiest way to analyse trends is through graphical analysis, giving a bigger picture overview of the results. To analyse trends using paper-based and legacy data storage systems, data often must be transcribed before analysis can occur, which can lead to questions over data integrity and the confidence which can be provided in the data.

Digitalising data using smart data storage systems such as SmartControl, where data has been input directly into the software, makes analysis of facilities and trends simple. These systems can pull all relevant data into floorplan heatmaps, graphs or reports automatically, and these can be customised and filtered to give the user confidence in the data being analysed. They ensure that all data from all environmental monitoring is easily accessible in one place, easily understandable and data can be reviewed as required.

Digitalising data not only moves the pharmaceutical industry more in line with the Industry 4.0 technologies, it also improves compliance, providing confidence in your data, and allowing companies to take better decisions with their data.

Are you ready to meet regulation,  boost your data integrity and take better environmental monitoring decisions? Scrap the paper for SmartControl: click here to find out more today.