.png)
We are pleased to welcome Intact Digital to the Tetra Partner Network, and excited to share a recent conversation with Natasa Milic-Frayling, Founder and CEO. Before founding Intact Digital, Natasa worked at Microsoft Research, where she led the Integrated Systems team and Microsoft’s participation in EU-funded projects on digital preservation. Natasa is uniquely aware of the challenges and the importance of preserving digital data and tools for future generations within life sciences.
Please tell us a little bit about your background.
I am a mathematician by training but spent most of my professional life working with computer scientists on information and communication technologies. At Microsoft Research, I led the Integrated Systems team, which explored new use cases and developed novel designs and computational techniques. We were all dedicated to innovation and excited about the opportunities that digital technologies offer.
Besides computer research, I had the opportunity to work on two European projects, PLANETS and SCAPE, representing Microsoft Research as a consortium member. For eight years, I was involved in discussions and activities related to the preservation of digital content. I became aware of the challenges that memory institutions, such as national libraries, archives, and museums around the world, face when fulfilling their mission to preserve digital documentary heritage.
More importantly, I realized that the increased pace of technical innovation in computing speeds up technology obsolescence. That, in turn, puts at risk everything we created using computing technologies, from digital data and documents to sophisticated designs and computational models.
No digital content can be accessed and used without appropriate software, but as the computing field evolves and new technologies emerge, previous software becomes unsupported and unusable. That has an immediate impact on which digital content and tools future generations will be able to access and use.
Thus, paradoxically, the progress we make through computing innovation can potentially lead to collective amnesia, with important knowledge and data locked away in unreadable files and unusable systems, unless we take a concerted effort to prevent that.
In a few sentences, please describe Intact Digital and why you started the company.
I started Intact Digital to serve as a catalyst for change in our practices of managing the technology lifecycle. We must tame inevitable software obsolescence in order to avoid a loss of digital assets and enable digital continuity.
We must tame inevitable software obsolescence in order to avoid a loss of digital assets and enable digital continuity.
As a first step, Intact Digital is offering services to prolong the use of software that is required for long-term access to archived data and reproducibility of data analyses. We are focusing on regulated sectors such as life sciences and the pharmaceutical industry, where data must be retained for quality assurance purposes and must remain usable for decades.
Tell us about your INTACT Software Library, what makes it unique, and the problems it solves for your customers.
INTACT Software Library platform and services enable organizations to continue using software for as long as they need, beyond the market lifetime of the software product. We find the best method to prolong the use of the software for a specific purpose.
INTACT Software Library platform and services enable organizations to continue using software for as long as they need, beyond the market lifetime of the software product.
For example, pharmaceutical organizations conducting pre-clinical studies must retain raw instrument data that supports drug discovery for as long as the product is on the market. That can be 20 to 30 years. In that endeavor, they are expected to follow ALCOA principles to ensure long-term data integrity. Data must be clearly Attributable, Legible, Contemporaneous, Original, and Accurate while it remains Complete, Consistent, Enduring, and Available for the entire data retention period.
The dependence of digital data on software makes it difficult to adhere to ALCOA principles. If the software is not available and functional, one cannot ensure data readability and accurate reconstruction of studies from the original data. Thus, the latest OECD guidance on data integrity states that the software needed to read and use digital data needs to be maintained in a usable state and suggests that this can be achieved in virtual environments.
Based on advances in software virtualization, INTACT Software Library provides users with fully validated and reliable installations of their software with convenient and secure remote access from their modern computers. It makes legacy software use as easy as browsing the Web. The users simply log in and access different software in browser tabs. They bring a copy of their archived data securely into the Software Library and perform tasks. Afterward, they can delete the data copy as needed. The data archive stays intact and usable. The Software Library gives them peace of mind by protecting the data and software from obsolescence.
How does Intact Digital approach obsolete software in life sciences and provide effective and sustainable solutions for customers looking for digital continuity?
Every software application or system relies on a number of technologies, starting with PC hardware and the operating system that makes the hardware usable. Thus, installing specific software requires careful consideration of all the technologies that it depends on. With a wide variety of software and installation requirements, this sounds like an impossible task. However, there are several factors that make this effort feasible and effective.
Producers of hardware and operating systems sell their products across industries. For example, the Microsoft operating system Win 7, now out of support, has been used across sectors to support the use of software. Thus, our solution to long-term software use is applicable to all of them. If we set up a computing environment for long-term use, e.g., by installing Win 7 in virtual machines, any software that was used with Win 7 should be installable in that environment. Furthermore, a single software installation that is well maintained ensures readability of all the data created with that software.
The key is to conduct thorough testing to confirm that the software performs in the same way as it did during its original use. Intact Digital IT experts install the software and assist with quality assurance. Together with the software users, they document the software installation, testing, and use. Such effort is key to attaining digital continuity since we must ensure both the proper functioning of the software and the retention of knowledge and skills to install and use it.
Where have your customers seen success? How is Intact Software Library used to support GxP compliance and digital data integrity?
Intact Digital assists organizations that need to retain their data in a digital form and ensure that it remains usable for decades. By hosting the required software in INTACT Software Library, the organizations have reliable ‘readers’ of digital data. Since legacy software is fundamentally non-secure, keeping it in a dedicated environment, separate from everyday operations, removes the risk of security breaches. In the pharmaceutical sector, INTACT Software Library has been used to implement Good Laboratory Practices (GLP) for long-term data archiving.
Since legacy software is fundamentally non-secure, keeping it in a dedicated environment, separate from everyday operations, removes the risk of security breaches.
Innovation in drug discovery depends on sophisticated instruments that enable scientists to conduct experiments with molecules and observe their properties. Raw instrument data is presented to the scientist in a readable and interpretable form by specialty software. The software enables the scientist to assess the data's quality and decide next steps. By GLP regulations, the raw instrument data must be archived and remain accessible. Similarly, in drug manufacturing, software is used to ensure quality control and data analysis is retained to comply with Good Manufacturing Practices (GMP).
As instruments and technologies advance, the old instruments are decommissioned and replaced by new ones. The decommissioning process typically includes the software associated with the instruments. However, that means that no software is available to read the archived instrument data.
Together with a pharma client, Intact Digital has developed a method of ‘transitioning’ software from operational use to archival use. Thus, any GLP lab and any organization subject to GxP regulations can now adopt this procedure to ensure data integrity compliance based on validated software installations and reliable use of data.
Intact Digital is redefining the relationship between technology providers and users for the benefit of both. How does this lead to responsible technology innovation moving forward?
We cannot and should not try to curb innovation in computing because of legacy concerns. Instead, we must find a way to host and use legacy software in a sustainable and cost-effective way so that digital content can be generated without risk of obsolescence.
We cannot and should not try to curb innovation in computing because of legacy concerns.
Software becomes obsolete because it is not updated and becomes incompatible with contemporary computing environments. For example, a particular software may not be installable or may not have security patches necessary to run safely on a new operating system.
We cannot expect vendors to support and update their products indefinitely. That is economically infeasible. Even when software vendors provide a guarantee that a new software version will be able to open past data, that benefit may be short-lived. Many products get discontinued and software businesses become acquired or dissolved within years while data must remain accessible for decades.
Thus, we need a process for managing software installations separately from software vendors but with their support and close collaboration. Software vendors need to assist with two important aspects: issuing licenses for perpetual use of legacy products and providing software releases without digital rights protection, e.g., without a need for software activation. The latter is essential for re-installing software when the hosting platform and the supporting technologies are upgraded.
By working together, we can be effective in protecting the long-term value for customers. Moreover, through efficient management of legacy software, we will secure access to digital information, data, and knowledge for future generations.
What is the value of Intact Digital joining the Tetra Partner Network?
TetraScience and Intact Digital’s partnership provides customers with the ability to interface their data through the Tetra Scientific Data Cloud™ with legacy software, allowing customers to recreate data and reproduce data analyses as needed. Intact Digital brings to the Tetra Partner Network a means of protecting customers from digital obsolescence.
Intact Digital brings to the Tetra Partner Network a means of protecting customers from digital obsolescence.
By utilizing the Tetra Scientific Data Cloud for long-term data management and use within the INTACT Software Library, software providers can assure their customers that the value created with their technologies will last beyond the lifetime of any single product, tool, or service. Intact Digital will work with vendors to implement the best strategy for ensuring the clients’ long-term benefits.
Similarly, Intact Digital will assist customers directly with the long-term management of digital archives by enabling ongoing use of validated software installations that are needed for data access and compliance with the data integrity regulations.
Is there anything else you’d like to share with us?
Digital revolution has transformed all aspects of the human endeavor. We made great strides using digital technologies and now must find a way to make digital data, information, and knowledge last and remain usable by future generations. This is a challenge that requires the involvement of all stakeholders in the digital ecosystem. Together, with our collective expertise and goodwill, we will secure our digital future by safeguarding our digital past.