A Viewpoint by Izuan Lasirin, consultant at Amaris Consulting.
The push towards Industry 4.0 is rapidly gaining momentum. From government services to the manufacturing industry, companies are taking steps to digitize their existing processes and operations. For the pharmaceutical industry, having a robust integrated data storage system is not enough. The need to implement a paperless validation system is proving to be increasingly important for companies.
Traditional vs paperless validation
Traditionally, validation (e.g., equipment, computer systems, process) is performed by physically putting pen to paper and recording relevant data onto approved printed test documentation in accordance with cGMP and ALCOA+ principles. This typically involves seeking wet-signature approvals throughout the entire process. These documents are then physically stored and archived for the required number of years before being disposed of.
A paperless validation system aims to replace, or at least simplify this process. All aspects of this new system, from document creation, review, execution, approval, and storage, are done electronically. Validation test executions are performed using software applications which allow real-time data to be recorded contemporaneously.
A well-integrated system would also allow test executors to link their test protocols to the control systems, equipment, and instruments without having to print physical copies as supporting evidence. Approvals can be done simply by clicking ‘submit’. Data storage and archival would result in eliminating the need for large physical storerooms and the space needed would be reduced to a mere chip.
Paperless validation: how and why?
Electronic paperless validation systems are required to comply with FDA Title 21 CFR Part 11 which specifies the governing regulations on electronic records and signatures. These regulations ensure traceability and accountability. All users are signed up to the electronic validation system, with the appropriate levels of rights and access corresponding to their roles in the organisation. This means changes made to any documents stored in the electronic system can be traced back to a user.
The electronic paperless validation system can be linked to change control systems for better traceability. The existing paper system relies on the stakeholders remembering to write the right thing, in the right place, at the right time. It also depends heavily on legible handwriting and standardized good documentation practices (GDP).
Setting aside the environmental and economic advantages of saving paper, an electronic paperless system would result in the seamless and timely transition of documents from one stakeholder to the another.
The whole validation process typically involves multiple review process by the relevant subject matter experts and stakeholders. Through the current paper system, a single piece of documentation moves from hand-to-hand. This system requires well-structured and disciplined document management procedures to ensure documents are not lost in transition.
Using an electronic paperless system allows ownership of documents to be easily transferred with a few clicks. It would also make searching past records and data easier.
This electronic paperless system would encourage greater collaboration efforts as multiple stakeholders can contribute simultaneously. This ensures critical aspects of the validation process are not missed. This ability to work together on a particular document concurrently would also result in a shortened overall validation process.
The COVID-19 pandemic has caused major disruptions to every aspect of our lives and the pharmaceutical manufacturing sector was not spared. But it has also been the catalyst for the transition to digitalization. The virus has made contactless connections ever more necessary, and where possible, workers now operate virtually.
Pharmaceutical manufacturing site expansions are set to rise to fulfil rising vaccines and drug demands, which will also see an increase in manpower resources and interaction between associates. This means there is a need for electronic paperless validation system. All users, experts, and stakeholders can keep the validation process moving from anywhere in the world. Eliminating the handling of any physical documents and limiting communication to video chats, this is crucial in enforcing minimal contact between associates.
How to implement paperless validation
As with any system, there are advantages and disadvantages. The points above highlight the key drivers towards a fully electronic paperless validation system. But there are many important questions to be answered before taking the plunge, and often, pharmaceutical companies adopt a hybrid system (i.e., less-paper validation system) which could be seen as a compromise between full conversion and maintaining elements of the existing conventional systems.
In an industry where the adage is “if it is not documented, it was not done”, going paperless will require full commitment from every member of the organization as it is not just a change in operations and procedure but also a mindset shift. Implementing a well-integrated and robust system that demonstrates the efficiencies of electronic paperless validation will be key to this shift.
Fortunately, pharmaceutical companies are not expected to develop their own paperless validation systems from scratch. Over the years, several electronic paperless validation systems have become available and pharmaceutical companies have started to implement them. Many other companies have taken the hybrid approach by mixing different technologies and systems to continue to be safely operational despite the global pandemic. These solutions may seem temporary, but they are part of the path towards full implementation.
At Amaris Consulting, we can be your stepping stone as we strive to explore digital innovations and ideas to assist in implementing a holistic information system that is suitable for your paperless validation needs.