By: steve / Posted on: / Under: Validation

Disaster Recovery Business Continuity (DRBC)

Having a DRBC program in place, and tested, is a regulatory requirement. During an audit or inspection, the DRBC program can be assessed, with a keen eye on the lookout for a plausible range of scenarios.

You may have already seen terms like the following used as hooks to bolster observations and findings from audits or inspections:

  • Protection of records
  • Record retention
  • Backup and recovery (tested)
  • Validation
  • Consistent intended performance

Each of these can be directly traced to one-or-more regulations. But what are plausible scenarios?

Types of disasters

The WCPT categorizes disasters into four areas (1):

  1. Natural: includes immediate and secondary impacts (e.g., a fire then a flood).
  2. Environmental: technological or industrial accidents caused by humans, including forest fires.
  3. Complex: authority break-down (looting, attacks on strategic installations); includes conflicts and war.
  4. Pandemic: sudden onset of contagious disease, disrupting services and businesses, brings economic and social costs.

Most have covered, 1, 2, and possibly 3 in their DRBC. What about the fourth? Even if we did address all four, what about the unforeseen?

Digitalization of Validation

Digitization, synonymous with digitalization, is the process of converting text, pictures (including video), and sound into a digital form that can be processed by computer technology. Simply put, going paperless. Now, more so than ever, digitalization of Validation is critical for business continuity. There are many reasons why:

  1. Exposure and contamination control is critical. Paper-based systems are a problem because:
    1. Paper may be contaminated, requiring costly and laborious decontamination and sanitization.
    2. Paper requires physical presence at a location (e.g., controlled document repository) to access records.
    3. Paper-based systems require documents be brought into clean areas or manufacturing facilities. Physical presence increases the risk of contamination and spread.
  2. Digitization allows remote capabilities.
    1. For Computer System Validation (CSV), this can be performed and managed 100% remotely.
    2. Work can be delegated to available resources, worldwide, with follow-the-sun validation, 24/7/365 if required.
    3. Reviews and approvals can be available on-line, allowing authorized individuals the ability to work remotely (e.g., from home), efficiently and productively.
    4. On-line, real-time collaboration can be made available.
    5. For cleaning, equipment, and process validation, resources can be limited to the absolute minimum. Reduced traffic reduces potential contamination.

Bottom line, digitizing validation relieves organizations and individuals of the burden imposed by paper, while at the same time delivering capabilities above-and-beyond that of manual systems.

Cloud technology covers a broad range of scenarios

By leveraging cloud-computing and having a cloud-first strategy, organizations can prepare and protect themselves from virtually any scenario. If there’s a catastrophe at a geographic location, a datacenter can failover to a disperse location in milliseconds, unbeknownst to the end-user. Fault tolerance can provide assurance during a system failure. Load balancing can distribute work evenly. The system can be highly available up to five-nines (99.999%) or more; in other words, downtime will only be 5.26 minutes per year.

However, it still takes qualified individuals to maintain and manage the infrastructure. Nobody is immune, but there is a difference with cloud-computing.

Layers of Defense: the cloud-computing differentiator

We hear a lot of Personal Protective Equipment (PPE) which offers layers of defense. The same is true with cloud-computing, which you can think of as Personnel Protective Systems (PPS).

Leveraging cloud-computing can provide up to three-or-more layers of defense, such as:

  1. An organization’s personnel resources
  2. Resources from the software provider
  3. Resources from the hosting facility

In the event of a disaster you can exercise options with cloud-computing. If your team isn’t fully staffed, for whatever reason, you may rely upon the software provider and their team of professionals, then revert to normal business operations.

There’s Hope

The life science industry offers hope. We’re the industry that can deliver the vaccine. We’re the industry that makes medical devices. We must keep our business and our industry moving forward.

Working together we can all make a difference.

Reference

(1) What is disaster management? World Confederation for Physical Therapy (WCPT),  https://www.wcpt.org/disaster-management/what-is-disaster-management. Accessed 03-18-2020.

About the Author

Steve Thompson

Director Industry Solutions of ValGenesis

Steve has worked in the life science industry for over 20 years and has experience working for Fortune 50 and start-up pharma, biotech, and medical device companies. As Director of Industry Solutions for ValGenesis, Inc., he helps the life science customers realize the benefits of applied advanced technologies. He is knowledgeable of internal and domestic GxP regulations, was certified as a Parenteral Drug Association auditor and has audited hundreds of companies globally. He’s on the Editorial Advisory Board for the Institute of Validation Technology (IVT), faculty member for Knowledge Exchange Network (KENX), a published author and frequent speaker at conferences

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2 thoughts on “Business Continuity Plan (BCP) for Validation Program amid a Pandemic

  1. Completely true & very much practical in current scenario, that we really have to think any validation activity to keep operated the things live with cloud environment

    • Thanks for the feedback! Definitely must keep things going, in a compliant and validated state. Cloud and paperless is essential given our current scenario. Thanks again!

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