In the pharmaceutical industry, securing timely approval for product batch documentation is critical for ensuring product safety and regulatory compliance. Quality personnel face mounting pressures from sales and operations team to release batches and meet dynamic customer demands. Mitigating systematically through information chaos is where OneSC excels.
Imagine the dilemma of a Qualified Person (QP) who must navigate through 200+ documents gathered from over 20 supply chain partners in over the course of a week. Intricately scanning thousands of documents, each containing crucial details that have to be stringently checked, all while facing growing pressure from both the supply chain and operations teams to expedite the approval of a batch. The attention to detail required makes it a formidable challenge for any QP personnel.
The task of approving these batches involves dealing with a multitude of documents, data and information, often leading to high levels of stress and information chaos among industry professionals. In this article, we will elaborate the benefits of organised document systems and highlight the main challenges faced by the supply chain personnel on a daily basis.
Why We Need Organised Document Systems?
Pharmaceutical professionals such as QPs are involved in key batch approval processes and face numerous challenges that contribute to high stress levels. These challenges include:
- Information chaos to categorised documents
- Prioritise batch workflows
- Maintain competitive advantage
Information chaos to categorised documents
The sheer volume of documents, data and information associated with batch approval processes can result in disorganization and information chaos.
Tracking, accessing and managing this extensive data becomes an overwhelming task, potentially leading to inefficiencies and errors in the approval workflow.
Documents coming in through various mediums (email, faxes, Sharepoint, etc.) needing to be updated and sent back for final sign-offs from their respective departments can cause operational inefficiencies and delays in the approval process.
Prioritise batch workflows
The difficulty in discerning which tasks require priority by categorising outstanding batch documents for approval, specific for each supply chain and quality personnel.
The manual nature of batch processing can lead to duplication of effort that contribute to time-consuming delays. Ensuring the right task is allocated to the right personnel at the right time will lead to timely batch approval.
Prolonged approval timelines result in a reduced shelf life for products, resulting in a constrained window for sales, increasing the risk of wastage.
Maintain competitive advantage
Rival companies can strategically exploit delayed approvals, leveraging the opportunity to gain a significant competitive edge.
Delays in regulatory clearances can lead to substantial financial strain, as revenue generation is postponed.
Rapid changes in consumer preferences may outpace products awaiting approval, causing commercial adaptability challenges as prolonged approval timelines have the potential to render products outdated.
The Importance of Organised Batch Documents
Batch documents contain critical information about the manufacturing process, quality control tests and adherence to regulatory standards. However, the absence of said information can result in rejected documentation, causing delays and compliance issues.
To counteract this, the use of a batch document version control system is essential for tracking document revisions, specifying who uploads documents and for what purpose, clarifying the need of each document will emphasize better supply chain transparency and simplify approval processes.
Quantitative Benefits of Streamlining Document Systems
Easier Accountability of Users
Streamlined processes facilitate the tracking of batch approval progress, clearly assigning responsibility for each step of the process.
Enhanced accountability ensures prompt error resolution and prevents bottlenecks in batch approval.
More Organised Operations
Easy access to relevant document information promotes seamless collaboration across different departments and different supply chain partners removing the need for time consuming meetings.
QPs can easily access and track needed information, reducing the chaos associated with dis-organised data.
Reduction in Email Clutter
Supply chain partners can easily track and reference communication threads, leading to better understanding on what needs to be completed.
This results in fewer back-and-forth emails, streamlining communication and enhancing overall efficiency.
Reduced Storage Usage
Streamlining batch approval processes often involves digitising documents which can cut back on traditional paper usage costs.
This leads to reduced storage usage, improving data management and contributing to cost savings by minimising the need for physical storage.
Qualitative Benefits of Streamlining Document Systems
Enhanced Compliance
The manual certification process adds to the UK/EU pharmaceutical industry’s £244 billion expenses, according to Reuters. Human-error risks upto £480 million in product recall losses every year
A well-organised system ensures that batch document approvals consistently adhere to regulatory standards, reducing the risk of compliance issues.
Agile Decision-Making
Streamlined processes result in quicker decision-making, enabling faster responses to changing circumstances and capitalise on opportunities in the pharmaceutical industry.
Access to real-time insights enabling data-driven decisions to optimise operations.
Cognitive Burden Reduction
The reduction of manual, repetitive tasks and the integration of automation tools enhance supply chain partners abilities to strategically focus on critical decision-making and problem-solving.
This shift allows QPs to direct their mental capacity towards higher-value tasks, fostering an impactful contribution by saving more time to approve more batches.
OneSC serves as a pivotal solution, automating tasks for quality personnel and alleviating cognitive burden within the pharmaceutical industry. OneSC not only addresses practical challenges but, more importantly, it significantly contributes to stress reduction and mitigates information chaos.
By embracing OneSC’s digital solutions, the pharmaceutical industry can enhance compliance, reduce stress and pave the way for a more organised and efficient future. Ultimately, these improvements benefit both the industry and the patients it serves.
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