Built for the day the inspector arrives — every day.

The FDA doesn't schedule inspections for the days you're ready. The TMF doesn't get more inspection-ready by being mostly correct. PHI right-to-erasure doesn't accept "we deleted it" as proof. The platform you choose now decides whether your next inspection is a controlled exercise or 3 weeks of war-room reconstruction.

TeamSync is built for the regulated content estate that healthcare and life sciences teams actually own — TMF, eCTD, batch records, manufacturing batch records, quality events, controlled SOPs, PHI, the lot.

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 be in inspection condition continuously, not when the inspector calls. TeamSync's TMF surface is structured to that standard from day one — DIA reference model alignment, TMF Reference Model 3.x, completeness scoring, and an audit chain that's queryable, not reconstructable. → VP Clinical Operations page

GxP validation that survives every release.

Most platforms break GxP validation every time they ship a new version. TeamSync's release engineering is built around continuous validation evidence — every release ships with the validation pack regenerated, the change-control log anchored, and the IQ/OQ/PQ artifacts verifiable by your CSV team without re-running a six-month validation cycle. → Validation Lead page

PHI right-to-erasure with cryptographic proof, not a delete confirmation.

HIPAA, GDPR Article 17, the state-level privacy regimes — they all converge on the same demand: prove the data is unrecoverable, not just that it was deleted. TeamSync's per-tenant envelope encryption means right-to-erasure executes by destroying the key. The encrypted bytes become permanently unreadable. The proof is mathematical. → CMIO page

Quality events that close in days, not months.

Non-conformance, deviation, CAPA — when they take 3 months to close, the operations team learns to work around the quality system rather than through it. TeamSync's quality-event surface is structured around the four-week SLA that audit-mature organisations actually meet. → Chief Quality Officer page

Provider time recovered from chart chasing.

Providers spend an hour and 40 minutes per shift on documentation that should be automatic. TeamSync's clinical AI copilot — bounded by HIPAA, grounded in the EHR, evidence-anchored — gives that time back. Not pilot-scale; production-scale, with the audit pack the CMIO needs. → CMIO page

Regulatory submissions across regions, on one platform.

eCTD for the FDA. EU CTR for the EMA. PMDA-specific structures for Japan. The team that runs each one separately is doing twice the work and shipping with twice the risk. TeamSync runs one canonical content base with regional shaping at the submission step. → Regulatory Affairs page

Where TeamSync fits with the HLS stack.

You keep your EHR (Epic, Cerner). You keep your CTMS (Veeva, Medidata). You keep your eCTD publishing tools where they're working. TeamSync sits underneath as the records-of-record platform, the AI grounding surface, the audit ledger, and the right-to-erasure mechanism.

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

See the HLS regulator map →

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

Talk to us.

Talk to an HLS solutions engineer