Active digital preservation for pharmaceuticals

Protect critical long-term information assets. Meet FDA regulations and drive innovation.

The pharmaceutical sector is a high-risk and strictly regulated industry.  

In this environment, secure immediate access to trustworthy long-term digital information is fundamental to successful product discovery, development, manufacturing and marketing. 

In particular, R&D lifecycles can run into decades, and Good Practice (GxP) guidelines and FDA 21 CFR Part 11 regulations require digital information to be retained for as long as a product is on the market plus decades after. Ensuring accessibility and authenticity for large volumes of digital information over successive technology cycles and custodians has become vital for driving innovation and meeting strict compliance requirements.

Enabling compliant protection and access to long-term digital information

Accessing trusted digital information for re-use or to meet FDA and other regulations over long periods requires a different approach to traditional backup, archiving, storage and content management.

Preservica’s active preservation platform is purpose-built to tackle the unique challenges of protecting digital information over decades. This means ensuring critical information is securely stored, immediately accessible, trustworthy, and automatically transformed into formats that can be read and used by future applications.

It’s a solution that has been adopted and audited against 21 CFR Part 11 as well as being trusted by governments and corporations across other highly regulated industries including financial services, FMCG, and telecommunications.

A vast array of critical information spanning the life cycle of product development and distribution

The volume of digital information that pharmaceutical organizations need to keep for long periods can run into tens of millions of files in hundreds of different, often complex formats.

This includes laboratory/experimental work, research models, toxicology studies, regulatory submissions and correspondence, system validation and control records, clinical trials, predecessor records from acquisitions and mergers, patents and trademarks, clinical safety management, quality control, and marketing assets.

In addition, the widespread use of outsourcing to third parties, such as Contract Research Organizations (CROs), means that vital information is often spread across various networks and jurisdictions - putting it at risk.

Consolidating long-term information assets into a trusted active preservation system can lower operational cost, unlock value for product innovation and mitigate risk by ensuring secure immediate access to information vital for compliance, IP protection and legal disputes.

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Report

Benchmark: The governance of long term digital information

In 2017 new research from the Information Governance Initiative (IGI), revealed that 83% of organizations aim to realize direct business value from their long-term digital information, across such areas as market analysis, product innovation, and customer service, but only a minority (16%) have a viable approach for proper governance and preservation.

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Reasons to act now...

Forward thinking pharmaceutical organizations are taking action to protect long-term digital information assets from technology obsolescence. The benefits of acting now:

  • Critical information that your organization or third parties have held for the last 10 years might already be obsolete and unreadable

  • Meet computer system validation requirements and regulatory demands for access and retrieval

  • Enable information managers to more efficiently appraise and protect scientific information assets

  • Reduce cost and risk of third-parties (such as CROs) holding vital digital information

  • Reduce the cost and performance burden on operational and line-of-business applications by transferring older and official records to a trusted preservation system

  • Accelerate application retirement programs – by protecting the critical long-term information they contain

  • The volume and complexity of digital information continues to increase exponentially - this requires an at scale solution for ensuring vital records can be found, used and trusted when required

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Blog

Digital preservation high on the agenda at recent Information Governance and Records Management conferences

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Resources

Digital preservation 101

Read our one page primer on active digital preservation

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White papers

Essential guide: Safeguarding your vital long-term electronic records

Integrating Digital Preservation into the Information Governance Lifecycle to ensure long-term electronic records are findable, readable and useable when required.

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Ready to future-proof your business? Get in touch today