A leading biotechnology company developing life-changing biologic medicines transformed its paper-based, wet-signature workflows into a validated electronic signature and electronic records system, then kept it continuously compliant with USDM Cloud Assurance for DocuSign.
Challenge
The company was weighed down by burdensome manual paperwork and wet signature documents that were time-consuming and prone to errors. In the regulated life sciences industry, the average cost of a wet signature is $50 per signee per document — far more expensive than eSignature. With a growing volume of paper-based documents requiring an average of 4 signees per document, the cost was becoming problematic, and the paper-based workflows were creating a bottleneck in productivity.
The core challenge was implementing a document management system that could streamline these workflows while complying with the FDA's 21 CFR Part 11 regulation. The company needed a solution to host large volumes of electronic records and documents — one that was easy to validate and, critically, easy to keep validated as the system evolved. Meeting 21 CFR Part 11 requirements for electronic signatures and records, and preserving data integrity across every signed record, were non-negotiable.
Approach
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:
- Validation Plan
- IQ Report
- OQ Plan and Report
- PQ Plan and Report
- Final Validation Report
This complete deliverable set gave the company the documented evidence needed to demonstrate software assurance and a defensible compliance posture.
Continuous compliance, not a one-time validation
Validation is not a one-and-done event — cloud applications like DocuSign release updates regularly, and each release can put a validated system out of compliance. 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 so 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 — eliminating the $50-per-signee wet-signature cost across documents that averaged 4 signees each.
- Paper bottlenecks eliminated through a validated DocuSign eSignature and eRecords system.
- 21 CFR Part 11 compliance achieved with a full validation deliverable set.
- Continuous compliance maintained as Cloud Assurance manages every monthly DocuSign update.
By opting for the easy button enabled by Cloud Assurance, the customer can trust its DocuSign system is continuously compliant and redirect valuable internal resources toward its core mission of developing life-changing biologic medicines.
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