Although there have been many advances in life science technology in recent years, a large section of manufacturers across the globe still maintain manual paper records rather than electronic ones.
Even for the largest companies that implemented manufacturing execution systems (MES), a huge volume of paper records still remains. These can be for batch records, SOPs and work instructions, e-Log books, shift registers, etc. The list is endless.
One reason for this is that most organisations tend not to extend the use of MES to clinical and R&D departments, labs or single-use/flex factory environments.
This large presence of paper-based processes has become an important issue during the current health emergency. COVID-19 has brought about pandemic-related shutdowns that have caused a significant reduction of employees on site (up to 75% in some instances). As a result, processes and people are quickly adapting to new ways of working remotely.
Minimising the use of paper and fully digitalising batch records in a secure and effective manner has become a priority.
The challenges of relying on paper-based processes and manual data entry
An extensive use of paper forms doesn’t support the digital transformation goals and ambitions of our clients, notes Jim, or the development of an inherently remote workforce, which has been accelerated owing to COVID-19. When documents are paper-based, people must be on site to fill, check and sign them.
In the current climate, this can increase risks and cause sign-off delays, especially in a remote-working environment.
Jim Lehane
Even when travel bans are finally lifted, local authorities may impose restrictions again with little notice. There is a need for a flexible solution wherein processes are not disrupted if all employees start to work from home again. A paper-based approach creates additional problems:
- errors, lack of data integrity and incomplete or inconsistent entries, which might have to be corrected with additional time and cost
- storage costs are higher and damage from fire or water is also a risk factor
- information in physical archives is hard to retrieve quickly (especially in the case of audits), which can hold up batch release
- it’s not ecofriendly
- restricted ability to release the value from the recorded data.
Avoiding these issues would help to reduce the soaring costs of developing drug products, which the Office of Health Economics (OHE) estimates to be £1.2 billion on average per new medicine.1
It would also greatly improve data integrity and accessibility in the drug development process, such as when reviewing and approving recipes and compiling batch production records. It would also support a more flexible workforce that may increasingly be working remotely.
The challenges of transitioning to a digital form approach
In spite of these issues, it can be hard to get rid of paper documents altogether. Full transition to a paperless MES can take up to 2 years and be hard to justify. At the same time, however, when a situation such as COVID-19 occurs, companies need to accelerate their paperless approach to ensure employee safety and support social distance initiatives on site.
Ultimately, the duty of every company is to ensure that people can access as much as they can remotely in a short space of time.
In light of this, some of our clients are exploring how to integrate their remaining paper-based processes into a digital format. However, it’s not enough to merely replicate paper on glass. Paper documents are used to record information, so they should keep that function once they are digitalised … rather than being mere pictures.
Developing digital forms with inbuilt intelligence
There are software tools currently on the market that use optical recognition to transform paper documents into smart content with input forms/templates that can be prepopulated, cross-checked, stored and compared.
These forms also have the ability to create sequences for reviews and approval, and allow real-time validation, conditional formatting and limits.
Optical character recognition systems can quickly transform paper documents into their digital twins within a couple of days rather than weeks or months. This pushes far beyond the limits of paper on glass.
Benefits of smart paperless manufacturing
With a smart record tool, information in paper documents becomes actionable and can deliver valuable insights exactly like native digital data. That brings several benefits:
- it supports a safe and remote workforce environment
- it saves a significant amount of time; for example, programming a 100-page batch record would require 6–8 weeks in paper format and 2–3 days in digital format
- data is easily accessible for audit trials, sign-offs and remote working; it can be stored securely and be measured, compared and analysed
- errors are reduced
- it streamlines the sequencing of processes
- it supports paperless transition
- answers can be standardised for cross-examination and insights
- it supports electronical sign-off
- it’s environmentally friendly.
When these forms integrate with existing MES modules, they can be a valid alternative to a 2-year full MES project, without the investment and inevitable disruptions to manufacturing that come with it.
The required infrastructure will be an IT environment built for secure remote access with a focus on network segmentation, multiple gated firewalls, detection bots and multifactor authentication.
With these tools, life science manufacturers can effectively complete their paperless transition with cost and time savings, reduced errors, improved efficiency of processes and workflows, and safe remote working if required.
Reference
1. www.ohe.org/news/overview-ohe-study-cost-drug-development-presented.