Challenge
A pharmaceutical company specializing in developing products for the acute treatment of medical conditions faced challenges managing its extensive collection of documents, including training records and internal forms.
The company needed an electronic document signing and management system to streamline its documentation processes and maintain compliance with the FDA's 21 CFR Part 11 regulations for electronic records and electronic signatures. It recognized the benefits of DocuSign but faced a critical question: could DocuSign be fully validated to meet those regulatory requirements?
Approach
The pharmaceutical company engaged USDM as its trusted validation partner. USDM's team of experts fully validated the DocuSign system using a risk-based, computer software assurance mindset, delivering a complete, audit-ready validation package.
The validation deliverables
- Validation Plan — defined the scope, approach, and acceptance criteria for the effort.
- Installation Qualification (IQ) — confirmed the system was installed and configured correctly.
- Performance Qualification (PQ) — demonstrated the system performed as intended in the company's environment.
- Validation Final Report — documented results and formally closed out the validation.
By grounding the work in established data integrity principles, USDM ensured the electronic signing workflows would hold up to regulatory scrutiny.
Results
Following the implementation and validation efforts led by USDM, the pharmaceutical company successfully addressed its electronic document signing and management needs while maintaining compliance with the FDA's 21 CFR Part 11 regulations.
With DocuSign fully validated, the company replaced manual document handling — across training records and internal forms — with a streamlined, compliant electronic system, and gained a documented foundation it can carry forward to keep its e-signature platform in a state of continuous compliance.