Digital Signatures, Document Management, Esignatures, healthcare, Pharma, Security and Compliance

Is your Life Sciences Business Ready to Face Coronavirus Disruptions?

Digital-Life-Sciences

The coronavirus pandemic is likely to bring a challenging situation for the business world. Most of the business associations have already started working to mitigate the risks and save their employees and customers. Still, the question of efficient business continuity remains unanswered.

No doubt, COVID-19 will have dreadful after-effects on many business areas especially in the life sciences industry. The reason is, many businesses in the industry are not ready to face the COVID-19 challenges. Resulting which, they are experiencing downfall in their productivity and in their ability to adapt and respond to business processes systematically.

Smart-Document-Solution

Conducting a quick radar scan of the business processes that are disrupted or are likely to be disrupted by COVID-19 is the need of the hour.

To ease out this process, here’s a quick combination of both the business’s “outside-in” and IT’s “inside-out” disruption questions that you must answer:

“Inside-Out” and “Outside-In” COVID-19 Disruption Questions by Gartner

Business Function
“Outside-In” COVID-19 Business Disruption Questions
“Inside-Out” COVID-19 IT Disruption Questions
Supply Chain
Can we inspect raw materials at a different source?
Can we predict the upstream/downstream shortages and address “panic stockpiling?”
Can we postpone or reschedule production at key production stages where there is optimal bandwidth on extended shelf and storage options?
Can we redistribute critical inventory or materials at a regional and country levels to ensure fast final-mile delivery in remote/critical need locations?
How do gain visibility into upstream (supplier) and downstream (customer) disruption or demand spikes?
How do we ensure our supply chain partners (i.e., suppliers, CMOs, logistics providers) are able to function at necessary capacities?
What is the response and agility of governments and regulators to adopt special measures to streamline distribution?
What are the IT implications of working remotely for your supply chain partners?
Which new data sources are on the horizon for integration?
What supply chain systems will be impacted?
Can we still support product serialization and broader compliance obligations with current IT systems?
Can we source or inspect raw materials and intermediates at different locations using current systems ?
Safety and Serious Adverse Event Reporting
How will potential lack of COVID-19 testing impact surveillance and reporting on active trials?
Can we expect an uptick in adverse events, given COVID-19 concerns among healthcare providers?
Are the effects of our products on a COVID-19 patient clearly understood?
Are existing safety case management capabilities impacted by COVID-19 containment measures? Do we need to consider moving this to another provider?
Can our existing case management facility handle any uptick in case volume? Does this need to be augmented by external services?
Regulatory Affairs and Operations
Will we be able to support our preregulatory filing meetings in virtual settings?
Will this impact regulatory submissions? How about agency review timelines?
Does existing regulatory intelligence capability provide the means to make informed decisions?
What virtual conference tools must be in place to enable uninterrupted regulatory affairs operations?
What remote and virtual meeting tools are needed to ensure continued operation of submission processes?
Do regulatory country and regional affiliates have the tools needed to continue uninterrupted operations?
Do central regulatory decision makers have the regulatory intelligence tools required?
Quality
Will we still be able to access our quality systems in remote-fashion? From any device? How does this vary with respect to on-premises vs. cloud deployments?
Will we be able to update our procedures and other quality documents? Measurement capability? Tracking?
What is the regulatory agency approach to inspections during the crisis? Can such inspections be supported remotely?
Are current quality IT systems impacted?
What is the impact on current QMS and quality documentation processes like witnessing batches, signatures in notebooks and visual inspection capabilities?
What, if any, impact exists with respect to QMS integration with other business systems or production equipment?
Do deviation and quality management systems support tagging COVID-19 issues for visibility?
Product Design/Medical Device
Can product engineers continue to collaborate and annotate drawings with nonengineering teams?
Can we amend our policy for accessing sensitive prototype information from home?
Are the virtualized CAD and CAE viewers adequate for your remote product development?
Can existing PLM support the work processes?
Can nonengineers print and provide feedback for key drawings during reviews?
Which digital rights and permissions are impacted? Do you have product or design datasets that cannot be accessed?
Manufacturing
Can we operate manufacturing lines or MES components remotely? With less staff?
Can we amend the LMS content in the workflow and continue compliant equipment operation?
Do we have IT support for alternative manufacturing logistics partners?
Are the current suppliers and partners able to provide services and ongoing work?
Do the MES and EBR systems still function under new workloads and GMP environments?
Which suppliers are your alternatives? What is needed from an IT perspective?
Laboratories
Is there anyway for us to access instrument files and laboratory operations from home?
Can we still log into our lab informatics systems (ELN, LIMS, CDS, etc.)?
Can we get a snapshot of our time-sensitive reagents and logistics status?
Are asset maintenance and calibration schedules going to be delayed? What about outsourced lab IT partners?
Do we have a policy that allows for specialized on-site work?
Do we need to change our software licenses? Support model?
Which systems are GLP vs. non-GLP?
Do our workflows require bridge systems? Can it work in existing ELN, LIMS and CDS?
Which systems cannot be moved to the cloud for compliance, GxP or regulatory reasons?
Early Research and Drug Discovery
What is the impact of scientific meetings and industry event cancellations on innovation, projects, milestones and collaboration?
Will our scientific applications (such as bioinformatics and molecular modeling tools) work from home?
Which key applications and informatics datasets need to be accessible remotely?
Which scientific workflows are impacted by employee location?
Do we have the right types of software licenses to support remote work?
Commercial Operations
How will we maintain open lines of communications with healthcare professionals?
How can we align our processes and content to ensure coordinated messages across the organization?
How can we deliver effective training on our products and sales strategies? And collaborate on our strategic customer discussions?
In the short term, how can we leverage remote engagement capabilities while ensuring compliance with CRM processes?
Do we need to accelerate our content development and approval processes to deliver personalized content? In the short term, how can sales representatives assist in orchestrating personalizing messages to physicians?
How can we leverage virtual technologies to enable peer to peer physician education?
Do new mobile apps, digital engagement tools, such as chatbots and voice assistants, need to be rapidly augmented or accelerated?
What virtual training solutions must be in place to enable uninterrupted sales training?
Clinical Development
How does COVID-19 impact our recruitment, retention, and site startup activities?
How shall we manage the uptick in patients’ missing visits, dropping out, and resulting additional protocol deviations?
How will global clinical supply chain and logistics be disrupted during the crisis?
What if subjects cannot get to their sites? For example, what if they cannot take commercial flights due to government travel restrictions?
What about trial delays due to lack of site commitment, resources, staff, and reprioritization?
What will be the impact of missed subject visits, treatment, and trial procedures to protocol endpoints?
Do current eClinical systems support remote access for ongoing trials in the short term? Do they enable virtual subject, investigator, and monitoring visits?
If virtual subject, investigator, and monitoring visits cannot be managed in the short term, can IT provide these capabilities on future trials?
In the event of supply disruption, do trial supply management systems provide the forecasting and visibility to ensure supply management and rerouting as needed?
Does IT support capabilities to expand recruitment using new technology approaches with AI and real world data?
Do IT initiatives support patient engagement on trials for better retention, medication adherence, communication, consent, training and scheduling?
Does your IT strategy include digital and decentralized trials as a longer term goal?
Business Function
“Outside-In” COVID-19 Business Disruption Questions
“Inside-Out” COVID-19 IT Disruption Questions
Supply Chain
Can we inspect raw materials at a different source?
Can we predict the upstream/downstream shortages and address “panic stockpiling?”
Can we postpone or reschedule production at key production stages where there is optimal bandwidth on extended shelf and storage options?
Can we redistribute critical inventory or materials at a regional and country levels to ensure fast final-mile delivery in remote/critical need locations?
How do gain visibility into upstream (supplier) and downstream (customer) disruption or demand spikes?
How do we ensure our supply chain partners (i.e., suppliers, CMOs, logistics providers) are able to function at necessary capacities?
What is the response and agility of governments and regulators to adopt special measures to streamline distribution?
What are the IT implications of working remotely for your supply chain partners?
Which new data sources are on the horizon for integration?
What supply chain systems will be impacted?
Can we still support product serialization and broader compliance obligations with current IT systems?
Can we source or inspect raw materials and intermediates at different locations using current systems ?
Safety and Serious Adverse Event Reporting
How will potential lack of COVID-19 testing impact surveillance and reporting on active trials?
Can we expect an uptick in adverse events, given COVID-19 concerns among healthcare providers?
Are the effects of our products on a COVID-19 patient clearly understood?
Are existing safety case management capabilities impacted by COVID-19 containment measures? Do we need to consider moving this to another provider?
Can our existing case management facility handle any uptick in case volume? Does this need to be augmented by external services?
Regulatory Affairs and Operations
Will we be able to support our preregulatory filing meetings in virtual settings?
Will this impact regulatory submissions? How about agency review timelines?
Does existing regulatory intelligence capability provide the means to make informed decisions?
What virtual conference tools must be in place to enable uninterrupted regulatory affairs operations?
What remote and virtual meeting tools are needed to ensure continued operation of submission processes?
Do regulatory country and regional affiliates have the tools needed to continue uninterrupted operations?
Do central regulatory decision makers have the regulatory intelligence tools required?
Quality
Will we still be able to access our quality systems in remote-fashion? From any device? How does this vary with respect to on-premises vs. cloud deployments?
Will we be able to update our procedures and other quality documents? Measurement capability? Tracking?
What is the regulatory agency approach to inspections during the crisis? Can such inspections be supported remotely?
Are current quality IT systems impacted?
What is the impact on current QMS and quality documentation processes like witnessing batches, signatures in notebooks and visual inspection capabilities?
What, if any, impact exists with respect to QMS integration with other business systems or production equipment?
Do deviation and quality management systems support tagging COVID-19 issues for visibility?
Product Design/Medical Device
Can product engineers continue to collaborate and annotate drawings with nonengineering teams?
Can we amend our policy for accessing sensitive prototype information from home?
Are the virtualized CAD and CAE viewers adequate for your remote product development?
Can existing PLM support the work processes?
Can nonengineers print and provide feedback for key drawings during reviews?
Which digital rights and permissions are impacted? Do you have product or design datasets that cannot be accessed?
Manufacturing
Can we operate manufacturing lines or MES components remotely? With less staff?
Can we amend the LMS content in the workflow and continue compliant equipment operation?
Do we have IT support for alternative manufacturing logistics partners?
Are the current suppliers and partners able to provide services and ongoing work?
Do the MES and EBR systems still function under new workloads and GMP environments?
Which suppliers are your alternatives? What is needed from an IT perspective?
Laboratories
Is there anyway for us to access instrument files and laboratory operations from home?
Can we still log into our lab informatics systems (ELN, LIMS, CDS, etc.)?
Can we get a snapshot of our time-sensitive reagents and logistics status?
Are asset maintenance and calibration schedules going to be delayed? What about outsourced lab IT partners?
Do we have a policy that allows for specialized on-site work?
Do we need to change our software licenses? Support model?
Which systems are GLP vs. non-GLP?
Do our workflows require bridge systems? Can it work in existing ELN, LIMS and CDS?
Which systems cannot be moved to the cloud for compliance, GxP or regulatory reasons?
Early Research and Drug Discovery
What is the impact of scientific meetings and industry event cancellations on innovation, projects, milestones and collaboration?
Will our scientific applications (such as bioinformatics and molecular modeling tools) work from home?
Which key applications and informatics datasets need to be accessible remotely?
Which scientific workflows are impacted by employee location?
Do we have the right types of software licenses to support remote work?
Commercial Operations
How will we maintain open lines of communications with healthcare professionals?
How can we align our processes and content to ensure coordinated messages across the organization?
How can we deliver effective training on our products and sales strategies? And collaborate on our strategic customer discussions?
In the short term, how can we leverage remote engagement capabilities while ensuring compliance with CRM processes?
Do we need to accelerate our content development and approval processes to deliver personalized content? In the short term, how can sales representatives assist in orchestrating personalizing messages to physicians?
How can we leverage virtual technologies to enable peer to peer physician education?
Do new mobile apps, digital engagement tools, such as chatbots and voice assistants, need to be rapidly augmented or accelerated?
What virtual training solutions must be in place to enable uninterrupted sales training?
Clinical Development
How does COVID-19 impact our recruitment, retention, and site startup activities?
How shall we manage the uptick in patients’ missing visits, dropping out, and resulting additional protocol deviations?
How will global clinical supply chain and logistics be disrupted during the crisis?
What if subjects cannot get to their sites? For example, what if they cannot take commercial flights due to government travel restrictions?
What about trial delays due to lack of site commitment, resources, staff, and reprioritization?
What will be the impact of missed subject visits, treatment, and trial procedures to protocol endpoints?
Do current eClinical systems support remote access for ongoing trials in the short term? Do they enable virtual subject, investigator, and monitoring visits?
If virtual subject, investigator, and monitoring visits cannot be managed in the short term, can IT provide these capabilities on future trials?
In the event of supply disruption, do trial supply management systems provide the forecasting and visibility to ensure supply management and rerouting as needed?
Does IT support capabilities to expand recruitment using new technology approaches with AI and real world data?
Do IT initiatives support patient engagement on trials for better retention, medication adherence, communication, consent, training and scheduling?
Does your IT strategy include digital and decentralized trials as a longer term goal?

Once you have the answers to these questions, assess and prioritize short-, mid- and long-term plans. This will help your pharma business create the best possible resolutions to eliminate the extremely dynamic situation. For instance:

  • Short-term plans include all the critical or instant IT responses for the business. These should be now considered as ongoing “emergency” activities.
  • Mid-term plans include activities that need to be ready for when the COVID-19 pandemic begins to ease.
  • Long term plans include activities that need to be ready to address the post-COVID-19 situation.

MSB-Docs-Life-Sciences

Make sure to keep these plans dynamic as the end of COVID-19 pandemic is unpredictable till now. In the midst of all the disruptions caused by COVID-19 in the life sciences industry, MSB Docs came forward as a savior. Here’s how MSB Docs covered them all!

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