Pharmaceutical manufacturers are mobilising to rapidly produce treatments, tests and vaccines, which means the need to safeguard data integrity has become even more critical. The pandemic is also putting pressure on manufacturers to deliver at pace increasing risk. Here Hannah Bailey, Business Development Director of Intoware, explains how digitalisation is meeting these challenges.
workforce
Covid-19 continues to devastate communities the world over, with over stretched healthcare battling to save lives. Against this backdrop there has been intense scrutiny of the pharma industry’s ability to develop vaccines and treatments to combat the virus and provide the path to recovery.
In a short time, the pandemic has increased our dependency on technology and pharma companies are investigating digital solutions to help unlock greater productivity. This is much needed as the industry had been cautious in applying digital solutions to improve manufacturing operations, despite the challenges of global competition, cost competitiveness and now Covid-19.
Manual, paper-based processes are increasingly facing obsolescence, as more companies are looking to migrate from traditional approaches that are time consuming and prone to human error, where a small accidental deviation such as a deletion or duplication in standard procedure means data integrity is lost.
Prior to the pandemic, we had seen increased interest from pharma manufacturers in our automation platform WorkfloPlus to digitise their production processes. Since in our experience the challenge faced by many businesses is that they still rely on spreadsheets or even paper tick lists to complete tasks.
This may seem fine, but it fails to offer the accuracy or granularity that can be gained through digitising pharma manufacturing operations. Imagine being able to see for example, how long each task really takes; taking photos or videos to record information in real-time; accessing a process by scanning a barcode or calling for live-help if things need attention – all through a simple mobile device, tablet or headset.
By switching to digital work instructions, manufacturers not only get measured productivity improvements, but they can build a huge bank of consistent and complete data for audits and also use the same information to predict when failures may occur and satisfy compliance.
Ensuring compliance
Intoware developed WorkfloPlus to help digitise workflow processes that need to be followed using both mobile and augmented reality technology. In doing so it ensures that a process can be consistently followed, audited and provides the necessary data analytics to ensure compliance – ideal for highly regulated industries such as pharmaceutical.
WorkfloPlus ensures better compliance by providing a thorough audit trail of ‘who did what and when’, by cataloguing every decision point and action in manufacturing operations so there are fewer errors and at the same time it enables improved productivity. But what happens if the manufacturing landscape were to change quickly?
A single source of truth
The speed of change is rapid too, a change to the business process is sent to all users instantly, providing a “single source of truth”, it’s not sent as a paper trail, so everyone is working off the same version. This means it’s easier to schedule downtime and manage production demands as things change. But if you’re relying on spreadsheets or written notes, this change could take many days or even weeks.
Where humans are involved, errors too cannot be totally eliminated, but you can significantly de-risk your operation through automation and of course if you have the audit trail that allows users to analyse the data at a granular level you can make further enhancements to reduce risks.
Ultimately, workflow automation removes paper-based processes, improves communications and collaboration to help free manufacturers from silo-based processes that are the result of ad-hoc systems.
Digitalisation increases GxP (good practice) compliance
Digitalisation better supports industry standards and protocols too such as GxP required for pharmaceutical and medical device manufacturing to ensure products are safe, effective and useable.
GxP that refers to ‘good practice’ guidelines, where (x) is the discipline e.g..drug manufacturing. These practices are shaped by regulatory requirements to create a knowledge bank that determines how outcomes are achieved and quality requirements are upheld. Strict adherence to these standards is essential if you are to continue to operate.
To be GxP compliant you need to specify, document and log every critical action made by each employee in the development, manufacture and delivery of a product or project by every employee and in a way that is auditable – if it isn’t documented, it didn’t happen.
WorkfloPlus facilitates ‘good practice’ providing the right ‘tools’ to deliver visibility and accountability right across your operations by ensuring your processes are always ‘fit for purpose’ and there is no variation in product quality.
Bayer Pharmaceuticals digitises batch change-overs
Forward-thinking Bayer Pharmaceuticals is deploying WorkfloPlus with HMT headsets from Realwear to help streamline and manage its production change over process, in what is a highly regulated market.
Bayer
Drug manufacturing operations require regular cleaning and change overs between each batch, by using WorkfloPlus it allows this procedure to be taken in a constant and timely manner, to help minimise “down-time” for greater cost efficiency, while at the same time it provides thorough audit checks that satisfy GxP compliance better than any paper ‘tick-list’ could deliver.
As the pharma industry races to develop new treatments and vaccines, pressure is growing on manufacturers to operate more productively and cost effectively than their next competitor. At the same time increasingly stringent guidelines for data integrity, transparency and accuracy ensure products meet the required safety standards. This means it’s time for manual, paper-based operations to be abandoned, to help manufacturers gain the competitive edge from new data insights, consistent compliance and reduced downtime.