STRATEGIES TO EMBRACE THE

DIGITAL TRANSFORMATION
An Insight on the effects of COVID-19 on Life Sciences
Manufacturing and the Underlying Digital Transformation

Cloud Enterprise Asset Management Software for Life Sciences www.coolblue.com

Providing Industry Leading Insight

Blue Mountain Quality Resources has a unique

®

position in the Life Sciences industry. As the

industry leader, Blue Mountain has helped
hundreds of Pharmaceutical, Biotech, Cell
Therapy and Medical Device companies
embrace a digital transformation by
implementing Blue Mountain’s best-in-class Asset
Management software – enabling them to
leverage the cloud, drive paperless processes
and ensure regulatory compliance.

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 Content

• Overview
• The Data and Analysis
• Industry Impact of COVID-19
• Operations
• Supply Chains
• IT Infrastructure
• Asset Management
• Strategies to Embrace the Digital
Transformation
• Implement Paperless Processes
• Move to the Cloud
• Leverage Purpose-Built Software

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Overview

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Overview

This document provides insights

into the effects of the COVID-19
pandemic with input from members
of the Life Sciences community across
the globe.
Participants were asked to provide
anonymous responses to a series of
questions that ultimately provide
insight on the pressures to undergo a
digital transformation, as well as the
immediate and long-term impact of the COVID-19 pandemic.
Based on the survey results, Blue Mountain determined several strategies for overcoming current
challenges and embracing the digital transformation.

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Overview

The Data and Analysis

This document reveals trends and key recommendations uncovered in a survey offered to
more than 20,000 members of the Life Sciences community encompassing a variety of job
functions.

MAINTENANCE CALIBRATION QUALITY LABORATORY IT OTHER

These illustrations represent the weight of job functions for those who were offered the survey.

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Industry Impact of COVID-19

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Industry Impact of COVID-19

This section outlines the many findings and insights

derived from Blue Mountain’s survey results,
focusing on the impact to the Life Sciences
community in the following areas:
• Individual Jobs
• Manufacturing Operations
• Supply Chain
• Regulatory Compliance
• Maintenance of Manufacturing Equipment
• Calibration of Measurement Instrumentation
• IT Infrastructure

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 Disruption Everywhere

Across the board, the majority of those surveyed are experiencing significant impact on their
work environments, individual jobs, manufacturing operations and their ability to maintain and
calibrate assets. Additionally, there are overwhelming drivers for accepting new responsibilities,
heightened demand for products and pressures to reduce total amount of time physically spent
in facilities.
Some of our most prominent findings include:

14%
41% 66% 69%
MOVED TO IMPLEMENTED NEW,
STAGGERED SHIFTS ALTERNATING SHIFTS REDUCED ON-SITE STAFF SHIFTED TO WORKING FROM HOME

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83% of professionals surveyed have experienced
disruption in manufacturing.

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Disruption in Manufacturing Operations

Despite increases in demand for many Life

Sciences products, the COVID-19 pandemic
has led to an overall reduction in total
manufacturing lines. A majority of those 10%
surveyed also noted that they are required to
manufacture with reduced staff during shifts.
Most non-essential staff are being required to
66%
work from home, and in many cases, essential
production staff are being asked to reduce REDUCED MANUFACTURING
LINES
REDUCED ON-SITE STAFF

their on-site work by half. In turn, Life Sciences

companies are needing to meet demands with
both limitations in supply chains and staff.

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Disruption in Supply Chains

Approximately one-fifth of those surveyed are

experiencing a tightening in their manufacturing
supply chain. This is limiting their ability to
provide uninterrupted therapies to market.
With the FDA’s announcement to postpone
inspections of both foreign and US facilities, the 14%
TEMPORARILY CLOSED
FDA is leveraging other means of making sure FACILTIES

that consumers will continue to receive safe and

effective treatments. However, this decision has
slowed the import of APIs and raw materials
used for manufacturing. Aside from drugs in
18.5%
consideration for COVID-19 treatment, the FDA EXPERIENCING SHORTAGES
is continuing to monitor all drug shortages. IN APIs & OTHER NEEDED
MATERIALS

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Disruption in Maintenance & Calibration

Asset Management plays a critical role in meeting manufacturing demand and is essential
for manufacturing operations to continue. Given this, there is notable impact in the way that
maintenance of equipment and calibration of instrumentation are being performed during
this time. The overall impact points to the reliance on internal staff to continue to complete
necessary work. This includes efforts to increase training of staff, increase ratio of in-house
maintenance and calibration work and a decrease in reliance on outsourcing of work overall.

14% 9% 12.5% 28%

DECREASE IN INCREASE IN INCREASE IN INCREASE IN
OUTSOURCED MAINTENANCE TRAINING NEW
CALIBRATIONS ACTIVITIES REQUIREMENTS RESPONSIBILITIES

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Demand for Reliable IT Infrastructure

2x
The most common impact is the need for reliable 97.5%
IT infrastructures to accommodate remote work.
With the majority of respondents reporting that OF CLOUD APPLICATION
they are working from home, IT infrastructures,
MORE USERS ARE SATISFIED WITH
THEIR IT INFRASTRUCTURE
remote connections and the demand for critical
GMP applications to have maximum uptime and SATISFIED
WITH CLOUD VS.
performance has never been greater. ON-PREMISE

Remote workers in general have a higher

demand for improved performance and uptime
of applications than those working on-site.
Respondents utilizing cloud applications were
twice as satisfied as those using on-premise
69%
applications. SHIFTED TO WORKING
FROM HOME

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Strategies to Embrace the Digital Transformation

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Embracing the Digital Transformation

With the wide range of impacts COVID-19 has had on the Life Sciences, there are many
immediate, as well as long-term changes that the industry will face. The root of each of the
impacted areas mentioned revolves around leveraging technology and paperless processes,
increasing training/skillsets and a common desire to embrace a digital transformation. The
need for a digital transformation both now and proceeding into the future will not only
provide a continuity of operations in the face of a pandemic or other crisis, but will
ultimately provide an increase in productivity, profitability and quality of treatments for
patients.
This next section outlines strategies for Life Sciences companies to welcome and leverage the
digital transformation. Today, it is of utmost importance that the industry as a whole
continues to strive towards manufacturing safe and effective treatments – not just for
COVID-19, but for all drugs and therapies.

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“I want to assure the American public that we have full confidence in the
safety and quality of the products we all use every day and that the
FDA will continue to leverage all available authorities to continue to
ensure the integrity of the products we regulate.”

Commissioner of Food and Drugs - Food and Drug Administration, Stephen M. Hahn M.D

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 PAPERLESS EVOLUTION

Strategy 1: Implement Paperless Processes 1997 - 21 CFR Part 11

Landmark regulation for industry creates a

pathway to paperless

2000 - Y2K Upgrade Cycle

84% of participants are still utilizing paper-based
processes and have experienced delays in
performing work during this time. This causes
Year 2000 issues in software leads to upgrade
cycle
2004 - Web Based Systems
Web-based applications offer low-bandwidth,
broad use and are paperless friendly

concerns as it can potentially lead to data integrity 2007 - Blue Mountain Software Functionality

issues. In response, a third of those are immediately Specific focus on workflow functionality
2010 - Ubiquitous Wireless
implementing software and procedures to move to Wireless is available in almost all reaches of
paperless processes. facilities

2014 - Tablets
Long-term, moving to paperless processes is an
Tablet use becomes widespread
important necessity to remain competitive and to 2018 - Internet of Things (IOT)
continue to meet regulatory compliance. IOT devices becomes widespread in
manufacturing
2020 - COVID-19

Pandemic further drives need for paperless

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Vital Components to Implementing Paperless Processes
Workflow Automation creates a process
driven, automated work environment that
consistently executes and manages paperless
systems by maneuvering records throughout
their lifecycle.
Work Execution streamlines and controls
processes for technicians. Paperless systems
enable maintenance and calibration
technicians to focus on performing work
rather than processing paperwork.
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Document Management can be one of the
largest barriers of reaching a successful
paperless environment. Document storage
engines provide a simple solution to storing
records from external systems.
Mobile and wireless network access has
become ubiquitous. Wireless network access
within a facility can drastically improve the
success of a paperless environment by allowing
maintenance and calibration technicians to
utilize work execution tools in the manufacturing
area.
Strategy 2: Move to the Cloud

Remote working has many benefits for

companies, but also increases the overall IT
burden. Currently, there is an increasing trend
of hiring additional IT staff to support remote
workers. Long-term, the IT staff will be
instrumental in migrating or working with
SaaS vendors to implement critical, GMP
applications in the cloud.
Cloud applications provide enormous benefits
for companies including data redundancy,
minimal downtime, and managed updates and
servers – which better support remote
working now and regulatory compliance
requirements long-term.
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Benefits of Moving to the Cloud for GMP Applications

• Latest Service Releases & Hotfixes - always be on the latest versions

• Disaster Recovery & Backups - guarantee your data with geo-redundant storage
• High Availability Architecture - reduce the likelihood of unplanned downtime
• Reduce Validation Efforts - leverage vendors’ validation documentation
• Reduce Internal IT Management - alleviate internal IT application and infrastructure
management burden & eliminate the cost and maintenance of on-premise servers
• Achieving Data Integrity - complete workflows contemporaneously anywhere internet is
available, in the facility or at home

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Strategy 3: Leverage Purpose-Built Maintenance
& Calibration Software

Given the current decrease in outsourcing

maintenance and calibration work, Life Sciences
companies need purpose-built applications to
manage GMP requirements, regulatory
compliance, paperless processes and complex
data collection.
Technicians need to be able to access work
orders and record data via mobile devices on
the plant floor.

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Benefits of Purpose-Built GMP Asset Management Software

Blue Mountain Regulatory Asset Manager ® Asset

• Enterprise Asset Management system Management

• World-Class GMP Calibration Functionality Maintenance Calibration

Management Management
• World-Class GMP Maintenance Functionality
• 21 CFR Part 11 Compliance
• Cloud Application Materials Work
& Inventory Management
• Built for the Life Sciences
• Built-in best practices gained from 1,000+ validated Data Integrity
& Compliance
implementations worldwide
• Software and Blue Mountain generated validation package
withstand FDA scrutiny in 100s of customers’ audits
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About Blue Mountain Quality Resources

Blue Mountain Quality Resources is the leading developer of asset management products
and services designed exclusively for the Life Sciences industry.
In one seamlessly integrated system, Blue Mountain allows you to coordinate calibration and
maintenance management, all while ensuring full GMP compliance. Combining the
capabilities of a CMMS, EAM and CCMS, we offer an enterprise level system that’s both
best in class and easy to deploy.
For more than 30 years, we’ve worked with well over 1,000 customers ranging from niche
firms to the Fortune 500. Today, we focus exclusively on four segments of the industry –
Biotech, Cell Therapy, Medical Device and Pharmaceutical.

Learn more about our company: Blue Mountain Quality Resources®

Learn more about our software: Blue Mountain Regulatory Asset Manager®

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Additional Resources

• https://www.fda.gov/news-events/press-announcements/coronavirus-disease-2019-covid-19-update-
foreign-inspections
• https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-
regulated-products-while-scaling-back-domestic
• https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update
• https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-
regulated-products-while-scaling-back-domestic
• https://www.forbes.com/sites/jeannemeister/2020/03/31/the-impact-of-the-coronavirus-on-hr-and-the-
new-normal-of-work/#1a44e9722b60
• https://www.cnbc.com/2020/03/25/drug-shortage-experts-what-consumers-should-know-in-covid-19-
pandemic.html

Blue Mountain Quality Resources and Blue Mountain Regulatory Asset Manager are registered trademarks of
Blue Mountain Quality Resources, Inc.
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Cloud Enterprise Asset Management
Software for Life Sciences

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