Helping Companies Innovate, Faster

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Stephan Donze
Stephan Donze, CEO

AODocs

“AODocs will continue to deepen the capabilities of their product to address other areas of Life Science including employee training and risk management, and to expand coverage across geographies including the US, EMEA and LATAM.”

Many organizations are looking to leverage cloud services – but are unable to do so because of the complications and time required to manually validate cloud solutions every time a new version is released (which can be weekly in some cases). The benefits of cloud such as cost efficiencies, increased scalability, and the ability to shorten the product delivery cycle for innovation to submission, patient delivery and care improvements, are simply outweighed by the cost of manual validation. AODocs for Life Sciences offers a fully validated solution for organizations to automate their document control, change requests, audit tasks, corrective and preventive actions and deliver cloud-based workflows and document management solutions. Every new release of the AODocs platform is delivered qualified – and their registered implementation is validated when updated. “This continual and automated validation approach removes the manual burden typically associated with rolling out new versions of software, meaning that our life science customers can benefit from the new features and improvements that we release multiple times per year on AODocs, while being in compliance with their validation requirements,” says AODocs CEO Stéphan Donzé.

The idea to build a specialized solution for Life Sciences came a few years ago when AODocs started deploying its document management platform for customers in the biotechnology and medical devices business.

The AODocs engineering team, working hand in hand with these pilot customers, recognized that Life Sciences companies had consistent requirements – similar interfaces, workflows and document types for example – and a shared desire to use modern, collaborative, SaaS products despite the perceived regulatory obstacles. “Addressing all the Life Sciences compliance requirements while retaining the agile nature of AODocs was a challenge,” adds Stéphan. “One area, in particular, was the 21 CFR Part 11 regulation about electronic signatures, but we were able to cover it with the integration of strong, cloud-based 2-factor authentication in the document and change request approval workflows.”

One of the main benefits of AODocs for Life Sciences is the ease of deployment. In addition to its automatic software validation which typically reduces the time around Computer System Validation & Assurance (CSV&A) from months to days, AODocs provides pre-configured templates, built from experience with existing Life Science customers. AODocs customers who want to use the standard templates can be up and running within hours, while others still have full control over their environment to allow for further customizations if required.

Many organizations are trying to move away from paper-based processes to a digital environment. This is for a number of reasons – including increased agility, more robust compliance procedures, audit traceability, and the ability to work from home. As an example, a client was launching AODocs for Life Sciences when the COVID-19 pandemic hit the USA. The impact of the pandemic meant that no AODocs consultant could travel to the customer’s office, and for the client that meant a major stall in operations since they were just on the cusp of fully digitized records management. Thankfully, the project was not delayed for long, implementation was completed in a fully remote manner, and the client was actually able to return to capacity, even amid the lockdown with a nearly 100% remote workforce.

In 2019, AODocs secured its position as one of the fastest-growing content services platform (CSP) vendors in the market offering robust compliance, security & risk management, quality management, and document management capabilities. Now recognized in the Gartner Magic Quadrant for Content Services Platforms and as a Strong Performer in Forrester’s New Wave for Cloud Content Platform, AODocs is more and more seen by enterprise organization as a strong alternative to the traditional, legacy document management players thanks to its disruptive, cloud-native value. AODocs will continue to deepen the capabilities of its product to address other areas of Life Science including employee training and risk management and to expand coverage across geographies including the US, EMEA and LATAM. Further improvements will continue to increase AODocs’ core competitive advantages in ease of use, versatility and speed of project delivery.