5 hidden costs of paper in GMP manufacturing
5 hidden costs of paper in GMP manufacturing
GMP manufacturing doesn't come cheap. High-tech cleanrooms with costly equipment and reagents, specialized personnel, quality assurance procedures, and much more. A 2018 estimation of a small-scale cell therapy manufacturing costs showed that it can range from €21,000 to €190,00 for just one batch [1]. With such significant expenses, every choice matters.
So when it comes to paper-based documentation and spreadsheets, it's worth asking: is this practice costing more than we realize?
And if so, what can we do about it?
The hidden costs of paper
Paper is not free. But many are so accustomed to the familiar manual documentation processes of writing by hand onto documents and entering data into spreadsheets that the hidden costs they carry are rarely considered. It's these unspoken expenses, the ones we've normalized over time, that can quietly drain resources.
01. Paper is time consuming
Data entry, retrieval from storage, and managing the regulatory documentation can be time-consuming. Every sample and every batch has to be traceable, and filing documents manually takes up time that could be spent on more valuable tasks.
Even just simply bringing in, moving, sterilizing and managing paper safely can cost time. These manual steps not only stretch out production cycles but also introduce delays in crucial decision-making and the eventual release of products.
How can digitalization help?
With software, data entry and retrieval can become as efficient as one click. Data entry can be made even faster and error-free thanks to barcode scanning and device integrations. This could even connect to inventory management to stay on top of batches, samples, equipment and reagents, or be integrated with the quality management system to stay on top of SOPs, deviations and CAPAs.
Operations such as cleanroom cleaning, environmental monitoring or filling out batch records are streamlined and easily traceable through digital workflows, checks and balances, all done on a tablet that stays in the cleanroom and needs no additional time for everyday sterilization.
02. Paper comes with storage costs
Managing paper records in GMP manufacturing involves significant expenses coming from ensuring secure, fireproof, and waterproof storage. The conditions of the storage need extensive climate control, which is energy-consuming. Access to these documents has to be controlled, which involves additional costs in terms of security, such as locks, security personnel, and possibly surveillance systems.
Many companies digitize their paper records and use both paper and digital storage of scanned documents. However, there’s notable time costs in scanning and managing virtual storage of documents originally made on paper. Moreover, most of the original paper documents still need to be safely stored and traceable for 10 years. This means that GMP organizations quickly run out of physical storage space on-site and they need to transfer their documents to external ‘iron mountain’ facilities, which comes with yet additional logistics and costs.
How can digitalization help?
Digitalization is different from digitization, which is predominantly just virtual storage of manual, paper documents. Instead, digitalizing is a way of streamlining processes that fully gets rid of paper from the start. It uses electronic signatures, digital workflows, and secure and automated storage/management of documents. The security for digitalized GMP documents’ storage employs advanced encryption, multi-factor authentication, and sophisticated access control mechanisms, which work with automatic updates and only need occasional check-ups. And requires a very small digital footprint: only computers and tablets and the rest is cloud-based.
03. Error-prone data entry
In the world of GMP manufacturing, a slip of a pen can come at a high price. With paper-based systems, compliance with GMP and FDA regulations requires constant manual reviews of documentation with remarkable attention to detail. That’s because manual data entry errors and calculations can spiral into product recalls, regulatory fines, or even jeopardize the health of the patients.
How can digitalization help?
Lowering the risk of errors means lowering costs. Digital GMP systems, like MyCellHub, have built-in safeguarded interactive work instructions and automated data collection tools. Additionally, integrated 21 CFR part 11 and EU Vol 4 Annex 11 compliance tools facilitate audit-ready documentation and high quality of the produced therapies. By automatic spotlighting out-of-spec data, digital tools ensure you won’t miss anything in the documentation. Paired with Review-by-Exception mechanisms, this significantly trims down your review and approval time.
04. Limited accessibility
Relying on paper in GMP manufacturing brings about accessibility challenges. With data locked in paper documents or spreadsheets, there are added expenses of retrieval logistics, coupled with the inconvenience of not having 24/7 access. Furthermore, the process of obtaining signatures becomes cumbersome, requiring documents to be in the hands of decision-makers in-person.
How can digitalization help?
Digital systems tremendously improve accessibility in GMP manufacturing. By transitioning to cloud storage, data becomes available anytime, anywhere, eliminating the need for physical travel to retrieve information. With secure digital signatures, decision-makers can review and sign off on documents remotely, streamlining the approval process. Avoiding the hassle of physical signatures also saves money. According to DocuSign, pharma companies save on average $77 per document only by switching to electronic signatures [2]. The shift to digital data management not only enhances operational efficiency and boosts savings but also ensures that vital data is just a click away, regardless of location.
05. Loss of documents and damage risk
The GMP reliance on paper documentation is a gamble with potential costs. From the unpredictable threats of water damage or fires to the everyday hazards like simple wear and tear or an accidental coffee spill, the documents are constantly at risk. A regularly arising issue is simply misplacing the documents. Each damaged or lost document can lead to costly reproductions, delays, and potential regulatory complications.
How can digitalization help?
By going digital, GMP manufacturing sidesteps the vulnerabilities of paper. Stored on secure servers or the cloud, digital files are protected, easily retrievable, and immune to physical damage. The automatic synchronization feature enables saving the documents and their historic versions without a single click, and safe back-ups ensure that nothing gets lost.
Ditching paper for long-term savings
There's a prevailing myth in GMP manufacturing that setting up digital systems is cumbersome, expensive, and doesn’t follow the unique process of each facility. In reality, digital tools, like MyCellHub’s cloud-based solution, are not only easy to set up and customize, but also offer significant long-term financial benefits.
Find out more by getting in touch today.
GMP manufacturing doesn't come cheap. High-tech cleanrooms with costly equipment and reagents, specialized personnel, quality assurance procedures, and much more. A 2018 estimation of a small-scale cell therapy manufacturing costs showed that it can range from €21,000 to €190,00 for just one batch [1]. With such significant expenses, every choice matters.
So when it comes to paper-based documentation and spreadsheets, it's worth asking: is this practice costing more than we realize?
And if so, what can we do about it?
The hidden costs of paper
Paper is not free. But many are so accustomed to the familiar manual documentation processes of writing by hand onto documents and entering data into spreadsheets that the hidden costs they carry are rarely considered. It's these unspoken expenses, the ones we've normalized over time, that can quietly drain resources.
01. Paper is time consuming
Data entry, retrieval from storage, and managing the regulatory documentation can be time-consuming. Every sample and every batch has to be traceable, and filing documents manually takes up time that could be spent on more valuable tasks.
Even just simply bringing in, moving, sterilizing and managing paper safely can cost time. These manual steps not only stretch out production cycles but also introduce delays in crucial decision-making and the eventual release of products.
How can digitalization help?
With software, data entry and retrieval can become as efficient as one click. Data entry can be made even faster and error-free thanks to barcode scanning and device integrations. This could even connect to inventory management to stay on top of batches, samples, equipment and reagents, or be integrated with the quality management system to stay on top of SOPs, deviations and CAPAs.
Operations such as cleanroom cleaning, environmental monitoring or filling out batch records are streamlined and easily traceable through digital workflows, checks and balances, all done on a tablet that stays in the cleanroom and needs no additional time for everyday sterilization.
02. Paper comes with storage costs
Managing paper records in GMP manufacturing involves significant expenses coming from ensuring secure, fireproof, and waterproof storage. The conditions of the storage need extensive climate control, which is energy-consuming. Access to these documents has to be controlled, which involves additional costs in terms of security, such as locks, security personnel, and possibly surveillance systems.
Many companies digitize their paper records and use both paper and digital storage of scanned documents. However, there’s notable time costs in scanning and managing virtual storage of documents originally made on paper. Moreover, most of the original paper documents still need to be safely stored and traceable for 10 years. This means that GMP organizations quickly run out of physical storage space on-site and they need to transfer their documents to external ‘iron mountain’ facilities, which comes with yet additional logistics and costs.
How can digitalization help?
Digitalization is different from digitization, which is predominantly just virtual storage of manual, paper documents. Instead, digitalizing is a way of streamlining processes that fully gets rid of paper from the start. It uses electronic signatures, digital workflows, and secure and automated storage/management of documents. The security for digitalized GMP documents’ storage employs advanced encryption, multi-factor authentication, and sophisticated access control mechanisms, which work with automatic updates and only need occasional check-ups. And requires a very small digital footprint: only computers and tablets and the rest is cloud-based.
03. Error-prone data entry
In the world of GMP manufacturing, a slip of a pen can come at a high price. With paper-based systems, compliance with GMP and FDA regulations requires constant manual reviews of documentation with remarkable attention to detail. That’s because manual data entry errors and calculations can spiral into product recalls, regulatory fines, or even jeopardize the health of the patients.
How can digitalization help?
Lowering the risk of errors means lowering costs. Digital GMP systems, like MyCellHub, have built-in safeguarded interactive work instructions and automated data collection tools. Additionally, integrated 21 CFR part 11 and EU Vol 4 Annex 11 compliance tools facilitate audit-ready documentation and high quality of the produced therapies. By automatic spotlighting out-of-spec data, digital tools ensure you won’t miss anything in the documentation. Paired with Review-by-Exception mechanisms, this significantly trims down your review and approval time.
04. Limited accessibility
Relying on paper in GMP manufacturing brings about accessibility challenges. With data locked in paper documents or spreadsheets, there are added expenses of retrieval logistics, coupled with the inconvenience of not having 24/7 access. Furthermore, the process of obtaining signatures becomes cumbersome, requiring documents to be in the hands of decision-makers in-person.
How can digitalization help?
Digital systems tremendously improve accessibility in GMP manufacturing. By transitioning to cloud storage, data becomes available anytime, anywhere, eliminating the need for physical travel to retrieve information. With secure digital signatures, decision-makers can review and sign off on documents remotely, streamlining the approval process. Avoiding the hassle of physical signatures also saves money. According to DocuSign, pharma companies save on average $77 per document only by switching to electronic signatures [2]. The shift to digital data management not only enhances operational efficiency and boosts savings but also ensures that vital data is just a click away, regardless of location.
05. Loss of documents and damage risk
The GMP reliance on paper documentation is a gamble with potential costs. From the unpredictable threats of water damage or fires to the everyday hazards like simple wear and tear or an accidental coffee spill, the documents are constantly at risk. A regularly arising issue is simply misplacing the documents. Each damaged or lost document can lead to costly reproductions, delays, and potential regulatory complications.
How can digitalization help?
By going digital, GMP manufacturing sidesteps the vulnerabilities of paper. Stored on secure servers or the cloud, digital files are protected, easily retrievable, and immune to physical damage. The automatic synchronization feature enables saving the documents and their historic versions without a single click, and safe back-ups ensure that nothing gets lost.
Ditching paper for long-term savings
There's a prevailing myth in GMP manufacturing that setting up digital systems is cumbersome, expensive, and doesn’t follow the unique process of each facility. In reality, digital tools, like MyCellHub’s cloud-based solution, are not only easy to set up and customize, but also offer significant long-term financial benefits.
Find out more by getting in touch today.
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