Pharmaceuticals
From Paper Packets to Compliant Digital Signatures
Primary Area
Infrastructure & Cloud
Service Area
SharePoint Infrastructure Setup (Virtualization/Networking)
Products Used
SharePoint, Hyper-V
Roles Impacted
Chemical Engineers, other Scientists
Impact Highlight
80% time savings on critical signature approvals
Opportunity
A Fortune 50 energy company routed global clinical trial approvals through couriered paper signature packets—creating delays, tracking gaps, and escalating administrative cost across regions. Heightening FDA 21 CFR Part 11 expectations, regional data‑sovereignty rules, and inconsistent wet‑ink practices turned a compliance risk into an opportunity to modernize and standardize how regulated decisions were authorized.
Multi‑week cycle times caused study start delays and extended enrollment windows.
High courier, archive, and document reproduction costs across >40 countries.
Limited audit trail: who signed, when, and which version often required manual reconciliation.
Region‑specific signature rules (e.g., witness, dual signers) handled inconsistently.
Paper storage and retrieval slowed responses to regulators and internal QA.
Solution
Our team convened clinical operations, QA/regulatory, IT security, and regional study coordinators to map required signature intents, identity assurance levels, and record retention rules against 21 CFR Part 11 controls. We then designed and validated a Microsoft‑centered, virtualized SharePoint signing platform that replaced paper packets with controlled electronic records, aligned to the client’s vision while meeting every documented requirement.
People
Stakeholder alignment workshops across R&D, Legal, and regional trial sites.
Governance model defining system ownership, periodic review, and deviation escalation paths.
Identity & access policies tied to corporate lifecycle; multi‑factor authentication for high‑risk signatures.
Process
Standardized global e‑signature SOPs mapped to Part 11, EU Annex 11, and local health authority expectations.
Controlled document versioning; signature rules enforced by workflow (required signers, sequence, countersign).
Validation lifecycle (IQ/OQ/PQ) with traceability matrix.
Periodic re‑qualification triggers when regulated forms or study protocols change.
Technology
Microsoft SharePoint Server farms (geo‑distributed) on Windows Server clusters virtualized on Hyper‑V; segmented validated / non‑prod tiers.
Electronic signature workflows with SharePoint, Power Automate, and Power Apps forms replacing legacy InfoPath and paper templates.
Integration to Azure Active Directory (hybrid with on‑prem AD) for identity, conditional access, and MFA.
Digital certificate management via Active Directory Certificate Services.
Controlled PDF rendition service and immutable file stores using SharePoint Records Center with retention locks.
Impact
The company now completes regulated clinical approval signatures in hours instead of weeks, with end‑to‑end traceability and rapid retrieval during health authority inspections. Digitized regulated signing processes using SharePoint (21 CFR Part 11) eliminated paper records and reduced document turnaround time by 80%, materially improving operational efficiency and compliance.
Paper packets and international courier shipments reduced to near zero for in‑scope trials.
Centralized audit trail: signer identity, timestamp (with time‑zone normalization), document hash, and workflow history available on demand.
Faster study start: approval gating steps accelerated, compressing trial activation timelines.
Reduction in inspection finding risk tied to missing / illegible signatures and version mismatches.