Larry Ludensky

Quality Systems Management and Implementation

"The fact that we have everything well-organized, easily retrievable, and we're able to show the complete version and revision histories of documents and records makes the auditor feel really comfortable that we have a compliant and robust process in place."

The Challenge: Scale Compliance to Rapid Growth

Disparate and Inefficient Systems

Welldoc relied on multiple, outdated systems for document management and training, leading to inefficiencies and scalability issues.

Multiple Compliance Requirements

Operating in a regulated environment, Welldoc needed to comply with standards like ISO 13485, ISO 14971, MDSAP, FDA 21 CFR Part 11, HITRUST, and SOC 2.

Compliance Keeping Pace with Growth

With the company's growth and expanding product lines, maintaining up-to-date training and documentation across the organization became increasingly challenging.

How Dina Accelerated HITRUST Timeline with Ostendio:

Centralized Document Control & Training

Ostendio provided an FDA-compliant platform that centralized document control and training management, replacing Welldoc's disparate systems. This streamlined processes and improved efficiency.

Efficient Evidence Collection for Audits

Robust documentation and evidence collection capabilities enabled Welldoc to quickly retrieve and present key documentation during audits, enhancing preparedness and confidence.

Compliance Scalable Across Multiple Requirements

Welldoc's team doubled in size, Ostendio's platform supported the company's growth by maintaining up-to-date training records and ensuring compliance across the expanding organization.

RESULTS

Welldoc Achieves Zero Findings in MDSAP Audit with Ostendio

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Zero Findings in MDSAP Audit
Welldoc achieved a rare zero-finding result in their MDSAP re-certification audit, a testament to their robust compliance processes.
Enhanced Confidence in Compliance
The successful audit outcomes bolstered Welldoc's confidence in managing regulatory compliance for more complex clients.
Improved Document Control
The ability to quickly change, publish, retrieve, and control documents improved operational efficiency and audit readiness.

Don't take our word for it. Hear directly from WellDoc.

From Readiness
to Audit

"The fact that we have everything well-organized, easily retrievable, and we're able to show the complete version and revision histories of documents and records makes the auditor feel really comfortable that we have a compliant and robust process in place."

Keep Pace with Evolving Regulations

"We know in the regulatory arena, things change all the time. We have to meet with the FDA on an ongoing basis, and Ostendio helps us prepare for those meetings and ensure our documentation is always up-to-date."

Real-time Audit Collaboration

"We use Ostendio in real-time during an audit. We will be asked a question or asked to produce documented evidence of fulfilling a requirement and we’re able to bring it up quickly and efficiently for the auditor to see."

WELLDOC SUCCESS STORY

Welldoc Achieves Rare Zero Findings in Regulatory FDA Audit

"The fact that we have everything well-organized, easily retrievable, and we're able to show the complete version and revision histories of documents and records makes the auditor feel really comfortable that we have a compliant and robust process in place."

The Challenge: Scale Compliance to Rapid Growth

Disparate and Inefficient Systems

Multiple Compliance Requirements

Compliance Keeping Pace with Growth

How Dina Accelerated HITRUST Timeline with Ostendio:

Centralized Document Control & Training

Efficient Evidence Collection for Audits

Compliance Scalable Across Multiple Requirements

RESULTS

Welldoc Achieves Zero Findings in MDSAP Audit with Ostendio

Don't take our word for it. Hear directly from WellDoc.

From Readiness
to Audit

Keep Pace with Evolving Regulations

Real-time Audit Collaboration

Turn your greatest risks into your best assets.

Request a Demo

WELLDOC SUCCESS STORY

Welldoc Achieves Rare Zero Findings in Regulatory FDA Audit

"The fact that we have everything well-organized, easily retrievable, and we're able to show the complete version and revision histories of documents and records makes the auditor feel really comfortable that we have a compliant and robust process in place."

The Challenge: Scale Compliance to Rapid Growth

Disparate and Inefficient Systems

Multiple Compliance Requirements

Compliance Keeping Pace with Growth

How Dina Accelerated HITRUST Timeline with Ostendio:

Centralized Document Control & Training

Efficient Evidence Collection for Audits

Compliance Scalable Across Multiple Requirements

RESULTS

Welldoc Achieves Zero Findings in MDSAP Audit with Ostendio

Don't take our word for it. Hear directly from WellDoc.

From Readiness to Audit

Keep Pace with Evolving Regulations

Real-time Audit Collaboration

Turn your greatest risks into your best assets.

Request a Demo

From Readiness
to Audit