How CDMO Delpharm relies on Ideals to guarantee security during audits from global pharma clients

Overview

Delpharm is a worldwide leader in contract manufacturing and development of medicines. 

As a multi-specialist, Delpharm provides the majority of pharmaceutical forms available on the market to its more than 170 customers. Based in France, the company also has production sites in Italy, the Netherlands, Poland and Canada.

In 2020, while the world relied on the pharma industry to rapidly develop and mass-produce solutions for COVID-19, companies had to overcome restrictions on face-to-face meetings and find other ways of ensuring global quality and safety standards. 

Delpharm was no exception. To reassure its clients, regulators, and the public that the company’s work was still properly monitored, they had to find a secure and efficient way to carry out audits remotely. 

In the words of Delpharm’s Leader of Group Quality, Hendrick Duquesne, “Our clients and auditors need to see how we work. Our problems were how to easily share documents and securely manage their distribution?”

The context

After buying its first site in France in 1988, Delpharm continued to build up its position by acquiring manufacturing plants. Initially, it followed a typical path for contract development and manufacturing organizations (CDMOs), expanding within France before moving into other countries in Europe and North America. 

By 2023, its annual revenues were €1.1 billion, derived from a large range of dosage forms that include tablets and capsules, bottles and injectable ampoules, prefilled syringes, freeze-drying, suspensions, solutions, ointments and soft gel capsules. Today the company employs over 6,500 people.

In common with other CDMOs, Delpharm is subject to regular audit inspections by client teams from large pharma companies or third parties employed by smaller customers. With COVID-19 restrictions preventing face-to-face visits, Delpharm urgently needed to find a way of communicating confidential information remotely. 

Key challenges

Moreover, the company also needed to protect its in-house expertise and prevent its intellectual property from being leaked to competitors. 

With product development taking at least a year from the first proposal to the product launch, any solution needed to ensure that proprietary and other commercially sensitive information could be securely exchanged during this time with no risk of leaks.

Specifically, this required the ability to:

• Store and share highly confidential information quickly, easily, and securely
• Set different permission levels for employees, clients, and third-party auditors
• Monitor the activities around their manufacturing documents for compliance with different regulatory regimes

The team considered using other common file sharing solutions, but these options didn’t give sufficient control of their data, something Hendrick described as like “leaving our documents out in the wild.”

Solutions

After comparing several providers, the team picked Ideals as it comprehensively addressed their requirements, offering both robust security and efficient document management features. “Ideals best suited what we were looking for,” confirmed Hendrick. 

With Ideals, the team could:

• Rely on several security features for added protection, including “indispensable” watermarks
• Prevent users from printing documents without authorization
• Remove users once an audit was completed

Hendrick was impressed by how easy the system was to set up and use: “Allocating different permission levels was very straightforward.”

But most of all, he was happy because, “Ideals ensures that our documentation is not leaked, and we can have full control over how our data is managed and shared.”

The future

Having used Ideals to successfully fulfill its audit responsibilities during COVID-19 restrictions, Delpharm was convinced that the platform offers a trusted and secure alternative to face-to-face meetings. As a result, the company recently renewed its ongoing partnership with Ideals. 

Delpharm currently has 17 ongoing projects, with around 99% of the company’s data room use being for audits, and a new room created ahead of each inspection.

Hendrick is confident they made the right choice, moreover “it’s good to be able to offer our clients a solution, rather than have them telling us what to use.”

The Ideals security protocols give Delpharm peace of mind, and while many of its clients have chosen to go back to in-person inspections, other audits continue to be handled remotely for cost-saving or political reasons.

Asked if he would recommend Ideals, Hendrick’s reply is a resounding “yes!”