Ostendio Helps Welldoc Achieve Zero Findings in Audit Report

Case Study

How Ostendio Helps Welldoc Keep Up with Scale, Achieve Rare Zero Findings in Regulatory Audit

Challenges

Searching for an alternative to an expensive, cumbersome and time-consuming EDMS (Electronic Document Management System)

Maintaining regulatory compliance requirements efficiently with the ability to scale to a rapidly growing organization and expanding product line
Experiencing rapid company growth while needing to maintain training across the board

Solution

FDA-compliant software for electronic documentation (FDA 21 CFR Part 11) with built-in compliance frameworks to control quality management systems

An economical, centralized document control and security software with efficient document management and approval processes that eliminates disparate systems
Software with built-in training to easily track, record and maintain employee compliance records to quickly satisfy audit requirements

Results

Effective evidence collection leads to MDSAP audit with zero findings
Developed confidence in managing regulatory compliance for more complex clients
Ability to quickly change, publish, retrieve and control documents

The Challenge

Prior to using Ostendio, Welldoc had been using disparate systems for document management and training, including a costly and cumbersome electronic document management platform that was outdated, lacked responsive support, and did not scale.

Welldoc recognized the need to centralize its regulatory compliance program in a way that would allow them to remain adaptable in the healthcare industry and mitigate labor-intensive audits so it could manage new clients and client requirements, expand products, and a rapidly growing portfolio and team.

“We use Ostendio to help maintain our regulatory compliance, not only for document control, but for training as well,” said Larry Ludensky, responsible for Welldoc's Quality Systems management and implementation. Since Welldoc operates in a regulated environment, where ISO 13485, ISO 14971, and MDSAP are required for medical devices and Software as a Medical Device (SaMD) and cybersecurity compliance for HITRUST and SOC2, such as Welldoc’s digital health app BlueStar®, having document control and risk management software that helps them maintain a quality management system compliant with FDA 21 CFR Part 11 was also a must, Ludensky said.

The Solution

Organization and adaptability: a formula for compliance success in healthtech

Ostendio has helped Welldoc accomplish what their previous systems couldn’t provide–robust documentation practices, efficient evidence collection, and retrieval processes when needed to provide objective evidence to auditors.

“We know in the regulatory arena, things change all the time,” said Marina Dorotheo, Chief Marketing Officer at Welldoc. “We have to meet with the FDA on an ongoing basis, so how do you prepare for those meetings? How do we ensure that we’ve got new documentation when required?”

These specific challenges are ones Dorotheo says the platform addresses head on. Unlike other medical companies that might launch two or three products in one year, Welldoc may see three product releases in a matter of weeks, Dorotheo said, so being able to prove quality and compliance efficiently to the FDA is imperative to avoid any slowdown.

“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 make the auditor feel really comfortable that we have a compliant and robust process in place," Larry said.

In addition to the Documentation Module, Welldoc has seen value in the Training Module as their team rapidly expands. In the last year, Welldoc has seen record employee growth, doubling from 100 to 200 employees. Ostendio has allowed them to maintain up-to-date internal and required regulatory training records and proof of competency.

The Result

Efficient evidence collection leads to zero deficiency for MDSAP audit report

According to the Welldoc team, “in our environment, audits can occur frequently and with short notice,” so it’s critical to be prepared while maintaining control and quality. The company’s activity in the Documentation and Training modules in the platform allows them to keep up to date with compliance requirements and quickly and easily display evidence during an audit.

“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.”

- Larry Ludensky, Quality Systems Management and Implementation, Welldoc

“Last year, we had our MDSAP re-certification audit and we had zero findings. Anyone who knows the industry is aware of how rarely that occurs,” Ludensky said, adding that a large component of their organization’s operational excellence when preparing for audits is from using Ostendio.

According to Dorotheo, Welldoc receives frequent praise from auditors for having a well-controlled Quality Management System and remaining current on training and documentation. As their team and products expand, Welldoc continues to place a strong emphasis on the Document Management and Training Modules and credits these features as key drivers to their compliance success.

"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."

Larry Ludensky, Quality Systems Management and Implementation, Welldoc

About Welldoc

Welldoc®, a digital health leader revolutionizing chronic care, is integrating personalized, real-time and actionable insights into the daily lives of individuals living with chronic conditions, enabling improved health and outcomes. Welldoc’s comprehensive chronic care platform provides multi-condition support across diabetes, hypertension, heart failure and behavioral health. Welldoc’s flagship product, BlueStar®*, an FDA-cleared digital health solution, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team. Welldoc partners with health plans, health systems and employers with the goal of extending care, improving population health and reducing costs of chronic care.

*Welldoc Diabetes Rx/OTC is an FDA-cleared medical device (“BlueStar”), intended for use by health care providers and their adult patients with type 1 or type 2 diabetes. For full labeling information, visit welldoc.com. The other Welldoc products are non-FDA-cleared and intended to promote general wellness and education/self-management of various chronic disease states.

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