Learn how a leading biotech company improved efficiencies and saved costs with Cloud Assurance for DocuSign.
Situation:
A leading biotechnology company needed a solution for burdensome manual paperwork and wet signature documents. The company recognized the inefficiency of paper-based documents that are time-consuming and prone to errors. The average cost of a wet signature in the regulated life sciences industry is $50 per signee per document, which is significantly more expensive than the cost of eSignature. Given the growing number of paper-based documents requiring an average of 4 signees per document, the price was becoming problematic. Additionally, the paper-based workflows were creating a bottleneck in productivity.
Challenge:
The main challenge faced by the customer was their need to implement a document management system to streamline their workflows and comply with the FDA’s 21 CFR Part 11 regulation. In particular, the company needed a solution to host large volumes of electronic records and documents that were also easy to validate and manage the ongoing releases to ensure the system stayed validated after the initial validation.
Solution:
The biotech customer implemented DocuSign to minimize paper-based bottlenecks and transform operations with electronic signatures and records. By leveraging USDM’s expertise and best practice accelerators, the customer achieved a rapid, validated DocuSign system, including a Validation Plan, IQ Report, OQ Plan and Report, PQ Plan and Report, and a final Validation Report. To further ease their validation burdens, the customer subscribed to USDM’s Cloud Assurance managed service for DocuSign to offload release management. USDM now handles the ongoing monthly DocuSign updates to ensure the customer stays in a continuous state of compliance.
Results:
With the rapid validation from USDM, the customer saved significant time and money by transforming their paper processes to eSignatures and eRecords. By further opting for the easy-button enabled by Cloud Assurance, the customer can trust its DocuSign system is continuously compliant and better utilize valuable internal resources to focus on its core mission of developing life-changing biologic medicines.
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