Document Management For Healthcare and Life Sciences Records
Healthcare and life sciences organizations manage some of the world's most heavily regulated documents, from clinical trial records and quality documentation to manufacturing records and patient information. Keeping that information accurate, accessible, and compliant is essential throughout its lifecycle.
TeamSync is built for the regulated content that healthcare and life sciences teams manage day to day: TMF, eCTD, batch records, quality events, controlled SOPs, and PHI.
Talk to an HLS solutions engineer · See HLS use cases · Regulator coverage
What Healthcare And Life Sciences Teams Use TeamSync For
A Trial Master File that's inspection-ready every day, not just inspection day.
The FDA and EMA both expect the TMF to stay in inspection-ready condition continuously. TeamSync's TMF structure is built to that standard from the start — DIA reference model alignment, TMF Reference Model 3.x, completeness scoring, and an audit chain you can query directly rather than reconstruct. → VP Clinical Operations page
GxP validation that survives every release.
New software versions often mean redoing validation work. TeamSync's release process regenerates the validation pack with every release, anchors the change-control log, and keeps IQ/OQ/PQ artifacts verifiable by your CSV team without a lengthy revalidation cycle. → Validation Lead page
PHI right-to-erasure with cryptographic proof, not a delete confirmation.
HIPAA, GDPR Article 17, and state-level privacy laws all require proof that erased data is genuinely unrecoverable. TeamSync uses per-tenant envelope encryption, so right-to-erasure works by destroying the encryption key — the encrypted data becomes permanently unreadable, and that's verifiable. → CMIO page
Quality events that close in days, not months.
When non-conformances, deviations, and CAPAs take months to close, teams start working around the quality system instead of through it. TeamSync structures the quality-event process around a four-week SLA. → Chief Quality Officer page
Provider time recovered from chart chasing.
Providers often spend significant time each shift on documentation. TeamSync's clinical AI copilot, bounded by HIPAA, grounded in the EHR, and evidence-anchored, helps reclaim that time, built for production use with the audit trail your CMIO needs. → CMIO page
Regulatory submissions across regions, on one platform.
eCTD for the FDA, EU CTR for the EMA, PMDA-specific formats for Japan: managing each separately means duplicated work and more room for error. TeamSync maintains one canonical content base and adapts formatting for each region at the submission step. → Regulatory Affairs page
Where TeamSync Fits With The HLS Stack
You keep your EHR (Epic, Cerner), your CTMS (Veeva, Medidata), and your existing eCTD publishing tools. TeamSync sits underneath as the records-of-record platform, the AI grounding layer, the audit ledger, and the right-to-erasure mechanism.
Layer | Stays | Layer TeamSync owns |
EHR systems | Yes | Records-of-record + PHI custody |
CTMS / eTMF | Coexist | TMF platform + audit anchor |
eCTD publishing | Coexist | Source content + version control |
Microsoft 365 | Yes | Records-of-record + AI grounding |
Quality systems | Coexist | Quality event registry + audit |
Compliance, By Name
FDA 21 CFR Part 11 · HIPAA · GDPR Article 17 · SOC 2 Type II · ISO/IEC 27001:2022 · EU AI Act for clinical AI
Read Further
HLS use cases — TMF, GxP validation, quality events, PHI deletion, regulatory submissions
Customer references — anonymised outcomes by use case
ROI — TCO model and savings categories
HLS role pages — CMIO, Chief Quality Officer, Validation Lead, VP Clinical Operations, VP Manufacturing/QA, Regulatory Affairs
Where to meet TeamSync — DIA, ISPE, RAPS, HIMSS, BIO