Pharmaceuticals
Global Healthcare Company Improves Operations Through Strategic IT Project Overhaul
Primary Area
Infrastructure & Cloud
Service Area
SharePoint Infrastructure Setup (Virtualization/Networking)
Products Used
SharePoint, Hyper-V
Roles Impacted
Chemical Engineers, other Scientists
Impact Highlight
85 % reduction in approval lead time
Opportunity
Facing stringent FDA 21 CFR Part 11 requirements, a top‑10 global pharmaceutical company relied on couriered paper packets to capture wet‑ink signatures across 37 manufacturing and R&D sites worldwide. The delays, compliance exposures, and lack of audit traceability presented a clear opportunity to digitize approval workflows and elevate data integrity.
Challenges:
5–10 day average turnaround for critical batch records.
12 regional archives storing over 2 million pages, risking loss or tampering.
No real‑time visibility for Quality and Regulatory Affairs teams.
Manual reconciliation of signer identity.
Duplicate effort to meet Part 11 controls (audit trails, timestamps, record–signature linkage).
Solution
Our team formed a cross‑functional steering group, mapped current‑state processes, and introduced a harmonized signature capture model. The team architected and deployed three SharePoint farms with integrated Power Automate, Azure AD, and SharePoint Framework‑based DocuSign components, validated to Part 11 using GxP‑compliant templates.
People: Key users trained in electronic‑records SOPs.
Process: Electronic‑signature policy updated and approved.
Technology:
SharePoint with storage for sealed document capture.
Azure AD Conditional Access + MFA for unique signer authentication.
Power Automate & Power Apps for role‑based approval flows.
DocuSign for SharePoint add‑in with cryptographic timestamping.
Migrated GMP documents from Documentum and network shares.
Impact
Signature cycle time dropped from an average of 8 days to one day, and first‑pass compliance in FDA mock audits rose to 99 %. The platform now delivers clear traceability while saving a considerable amount in courier, storage, and deviation‑remediation costs.
85 % reduction in approval lead time.
Cut in audit‑preparation effort.
25 % decrease in batch‑release deviations linked to documentation errors.
Sheets of paper eliminated per year.
Scalable architecture aligned to Microsoft 365 cloud‑transition.