Challenges of continued verification process in the Pharma Industry

In today’s digital age, businesses generate an enormous amount of data. However, a significant portion of this data remains unstructured, causing challenges for organizations across various industries. One prominent factor contributing to this problem is the use of manual, paper-based systems in many sectors, including the pharmaceutical and biopharmaceutical industries. These outdated systems impede the efficient handling and processing of data, leading to data inaccuracies, process inefficiencies, and increased expenses. The need for a solution that can transform unstructured data into valuable business insights has become paramount.

Unstructured data: Factors contributing to its prevalence

The biopharma upstream/downstream process involves various stages and activities such as cell development, chromatography, viral clearance, final formulation, and sterile filtration, among others. These processes generate a significant amount of data and documentation(paper mostly), leading to several challenges:

  • Manually Intensive Data Management: The management of data in the biopharma industry often relies on manual processes, which can be time-consuming and error-prone. This includes data entry, data tracking, and data analysis, among other tasks.
  • Searchability & Findability: With a variety of data files in different formats, including PDFs, Word documents, PowerPoint presentations, and spreadsheets, it can be challenging to search for and find specific information when needed. This lack of searchability and findability can hinder decision-making and slow down processes.
  • Unstructured Data: Unstructured data refers to information that is not organized or easily searchable. In the context of biopharma production processes, unstructured data can include scanned PDFs, handwritten notes, or data collected from various sources that are not standardized or organized in a structured manner.
  • Time Consuming and Capital-Intensive: Dealing with inconsistent data formats, file flow, traceability across departments, and data harmonization can consume significant time and resources. The manual handling of data and the need for data verification and validation add to the overall capital investment required for efficient data management.
  • Reasons for Unstructured Data: Unstructured data may arise due to a variety of factors in the biopharma industry. These factors include the use of legacy systems or outdated technologies that do not support structured data, diverse data sources that produce information in different formats, and the historical reliance on paper-based documentation systems that are not easily digitized.

To address these challenges, the industry needs to adopt digital solutions and technologies such as data management systems, electronic documentation systems, and advanced data analytics tools. Implementing standardized data formats, automating data entry and analysis processes, and promoting data sharing and collaboration across departments that significantly improve data management efficiency in the biopharma industry.

CPV-Auto™ : A Potential Solution

Aventior’s cloud-based CPV-Auto platform automates the processing of unstructured data into structured, actional data and makes it accessible to teams to speed up investigation and analysis.

Implementing CPV-Auto can have a transformative impact on businesses with these business benefits:

Business Impact : CPV-Auto™

  • Quicker Data Processing: CPV-Auto™ accelerates data processing by providing Critical Production Parameters (CPP) up to 15 times faster than traditional methods. This enables businesses to make informed decisions swiftly, enhancing operational efficiency and agility.
  • Enhanced Data Security: The platform adheres to industry-leading data security standards. Being 21-CFR Part 11 compliant and meeting GxP norms, CPV-Auto™ ensures that your sensitive information remains protected. Its Cloud-based validated solution employs state-of-the-art security protocols.
  • Improved Decision-Making: By converting unstructured data into structured insights, CPV-Auto™ empowers businesses to make data-driven decisions. Actionable information derived from unstructured data can reveal customer preferences, market trends, and operational inefficiencies, leading to optimized strategies and increased competitiveness.

If you’d like to explore more about how we can tailor and implement CPV Auto in your enterprise, please contact us for a discussion or demo.

Transform Paper Documents Into Digital Insights.