What types of audits does ExcelSure perform?

Investigator site audits, vendor and CRO qualification audits, TMF audits, BA/BE Study audits, system and process audits, data integrity audits, mock regulatory inspections, and for-cause audits delivered on-site, remotely, or as a hybrid.

How is a mock inspection different from a routine audit?

A mock inspection simulates the real thing: unannounced document requests, staff interviews, and inspector-style questioning against FDA, EMA, and CDSCO conduct. It stress-tests both your documentation and your people before an actual inspection.

How often should we run independent GCP audits?

Audit frequency is best set by risk: high-enrollment or high-complexity sites, new vendors, and critical processes warrant more frequent review. We help you build a risk-based audit schedule aligned with ICH-GCP quality-management expectations rather than a fixed calendar.

Does ExcelSure support us during an actual regulatory inspection?

Yes. Beyond mock inspections, we provide front-room and back-room inspection support, help manage document requests and interviews during the inspection, and support structured responses to any findings afterward.

What standards do you audit against?

ICH-GCP E6(R3), applicable regional regulations (such as FDA 21 CFR, EU CTR, and India's NDCT Rules 2019), ISO 9001 quality principles, 21 CFR Part 11 for electronic records, and your own SOPs and protocols.

Division 02

Independent Quality Assurance & GCP Auditing

ExcelSure·Independent GCP Audit

ExcelSure is an objective, independent audit function that evaluates compliance against ICH-GCP, regulatory standards, and your study protocols. It surfaces gaps, strengthens quality systems, and keeps you inspection-ready.

Talk to us Explore capabilities

60% Drop

In Protocol Deviations

ICH-GCPISO 900121 CFR Part 11

Quality proven by independent evidence

At Excelion, quality assurance is not an afterthought bolted onto trial conduct — it's ExcelSure's entire reason for existing. We look past checklist compliance to the quality system underneath it, through continuous auditing and measurable process improvement.

Because ExcelSure operates independently of trial execution, sponsors get what internal QA rarely provides: an unbiased, defensible assessment of how their study would fare in front of a regulator, before the regulator arrives.

True Independence: Audits performed independent of study conduct, giving you objective findings you can act on and defend.
Beyond the Checklist: Root-cause depth over surface findings: we assess the quality system, not just the paperwork.
Inspection Readiness: Mock inspections and gap remediation that prepare your teams and documentation for the real thing.
Regulatory Fluency: Audits framed against ICH-GCP and the expectations of FDA, EMA, MHRA, and CDSCO, rather than a generic checklist.
Risk-Based Focus: Audit effort concentrated where patient safety and data integrity are genuinely at stake.
Culture of Quality: More than findings: we help build quality systems that hold up between audits, not only during them.

What ExcelSure delivers

A quality assurance toolkit spanning audits, CAPA, and risk-based oversight, aligned to ICH-GCP, ISO 9001 quality principles, and 21 CFR Part 11.

Investigator site audits and for-cause audits
Trial Master File (TMF) and documentation audits
Process and system audits
BA/BE Study Audit
Clear gap identification with actionable recommendations

How an ExcelSure audit runs

A transparent audit lifecycle: scoped, executed, and closed with verifiable outcomes.

01
Scope & Risk Definition
Audit universe, standards, and risk priorities agreed with your quality leadership.
02
Audit Planning
Detailed audit plans, agendas, and document requests issued ahead of fieldwork.
03
Execution
On-site or remote audit conduct: interviews, document review, and system walkthroughs.
04
Findings & CAPA
Graded findings with root-cause analysis and practical, prioritized remediation guidance.
05
Follow-Up Verification
CAPA effectiveness confirmed and closure evidenced, so the loop is genuinely closed.

Why sponsors choose ExcelSure

Independence you can defend: Audit conclusions carry weight with regulators precisely because we have no stake in the trial's conduct.
Auditors experienced with real inspections: Our auditors have supported organizations through regulatory inspections, so we audit against what inspectors actually probe.
Findings designed to close, not recur: CAPA discipline and trend analysis target findings at the root, so the same issues are less likely to resurface.
Right-sized for your risk: Risk-based scoping focuses audit effort where patient safety and data integrity are actually at stake.
Framed to recognized standards: Audits are conducted against ICH-GCP and the published expectations of FDA, EMA, MHRA, and CDSCO.
Quality that holds between audits: We help build the quality system, not just report on it, so compliance stays continuous rather than episodic.

Who We Serve

The organizations ExcelSure supports

Pharmaceutical Companies
Biotechnology Companies
CROs
Medical Device Companies
Vaccine & Biosimilar Developers
Academic Research Organizations

Questions, answered

The essentials sponsors ask before engaging ExcelSure. For anything more specific, our team is one conversation away.

Internal QA is embedded in the same organization it evaluates. An independent audit provides the objective, conflict-free assessment that regulators respect, and often surfaces systemic issues internal teams have normalized.