Mika Javanainen, M-Files Corporation01.28.16
Many pharmaceutical companies are now on the path towards a full throttle mobile transformation. Smartphones and tablets are standard equipment for sales forces, automating everything from new hire training and field visit preparation with physicians, to travel route planning and more. Mobile apps are also offering employees a more convenient way to access documentation and business processes.
What pharmaceutical firms are finding is that mobile technology has the ability to transform virtually every line of business—from manufacturing and research to sales, distribution and customer service. But, as these companies embrace mobile strategies to improve productivity, cut costs and support product innovation, they must also shore up the potential vulnerabilities that can be exposed from the improper and unregulated use of this technology.
How can pharmaceutical companies capitalize on the benefits of going mobile without compromising regulatory Compliance and quality management practices? What protections should be put in place when priming for the mobile enterprise?
Quality and Compliance Considerations When Going Mobile
Pharmaceutical companies must remain vigilant in ensuring the ongoing integrity of their quality and compliance practices when evaluating mobile strategies, particularly those that involve the management of core content assets. The use of enterprise information management (EIM) systems with native mobile apps has become more pervasive since these solutions enable employees to easily manage, share and process information they’re authorized to access from anywhere at any time, whether online or offline. More importantly, unlike most enterprise file sync and share solutions, modern EIM mobile apps can enable convenient mobile access to content without compromising EU or FDA regulatory requirements.
As the use of mobile devices and apps continues to become increasingly mainstream for pharmaceutical businesses, the following quality and compliance-related issues should be carefully considered:
Compliant Workflows with eSignatures
Electronic signatures stand at the center of the FDA’s 21 CFR Part 11 regulation. Making electronic signatures executable from the field via mobile devices can eliminate business bottlenecks, create added efficiencies, and support employees for whom mobile devices represent their primary method of communication. For example, if R&D updates a drug-related SOP , a notification can be instantly triggered to alert the clinical research team. As a result, lab technicians in the field can use their mobile devices or tablets to review the updated policy and attest that they have read and understood the new policy by providing electronic signature verification. With an EIM system driving and automating these information processes, the result is streamlined lab and drug manufacturing workflows and improved efficiencies.
Managing Risks and Deviations
Mobile apps can help pharmaceutical workers capture risks and deviations on-site immediately as they occur. Cameras in mobile devices can be used to capture photographic evidence of issues, therefore expediting their resolution. Observing issues proactively leads to fewer deviations and issues, and mitigates risks before deviations occur—offering businesses a more efficient and cost effective method for problem identification and resolution.
Trusted Audit Trails
Pharmaceutical businesses were early adopters of enterprise content management (ECM) and EIM solutions. As a result, many EIM solutions can furnish a full audit log on all information assets managed, tracked and processed within the system. When mobile applications are fully integrated with the core Solution , the activities performed by mobile users are also tracked and can be provided as evidence during audits. Many EIM platforms can organize and manage all enterprise compliance-related documents and associated processes with complete version history, automatic permissions and workflow steps.
Mobile devices give users the power to access, manage, share and process information at their fingertips, enhancing the speed and accuracy of business operations. As pharmaceutical companies embrace mobile enablement, they must be mindful to deploy solutions that safeguard compliance-related documents and processes, leveraging the benefits of going mobile while mitigating the risks.
Mika Javanainen
M-Files Corporation
Mika Javanainen is Senior Director of Product Management at M-Files Corporation. Javanainen is in charge of managing and developing M-Files product portfolio, roadmaps, and pricing globally. Prior to his executive roles, Javanainen worked as a Systems Specialist, where he integrated document management systems with ERP and CRM applications. A published author, Javanainen has an executive MBA in International Business and Marketing.
What pharmaceutical firms are finding is that mobile technology has the ability to transform virtually every line of business—from manufacturing and research to sales, distribution and customer service. But, as these companies embrace mobile strategies to improve productivity, cut costs and support product innovation, they must also shore up the potential vulnerabilities that can be exposed from the improper and unregulated use of this technology.
How can pharmaceutical companies capitalize on the benefits of going mobile without compromising regulatory Compliance and quality management practices? What protections should be put in place when priming for the mobile enterprise?
Quality and Compliance Considerations When Going Mobile
Pharmaceutical companies must remain vigilant in ensuring the ongoing integrity of their quality and compliance practices when evaluating mobile strategies, particularly those that involve the management of core content assets. The use of enterprise information management (EIM) systems with native mobile apps has become more pervasive since these solutions enable employees to easily manage, share and process information they’re authorized to access from anywhere at any time, whether online or offline. More importantly, unlike most enterprise file sync and share solutions, modern EIM mobile apps can enable convenient mobile access to content without compromising EU or FDA regulatory requirements.
As the use of mobile devices and apps continues to become increasingly mainstream for pharmaceutical businesses, the following quality and compliance-related issues should be carefully considered:
Compliant Workflows with eSignatures
Electronic signatures stand at the center of the FDA’s 21 CFR Part 11 regulation. Making electronic signatures executable from the field via mobile devices can eliminate business bottlenecks, create added efficiencies, and support employees for whom mobile devices represent their primary method of communication. For example, if R&D updates a drug-related SOP , a notification can be instantly triggered to alert the clinical research team. As a result, lab technicians in the field can use their mobile devices or tablets to review the updated policy and attest that they have read and understood the new policy by providing electronic signature verification. With an EIM system driving and automating these information processes, the result is streamlined lab and drug manufacturing workflows and improved efficiencies.
Managing Risks and Deviations
Mobile apps can help pharmaceutical workers capture risks and deviations on-site immediately as they occur. Cameras in mobile devices can be used to capture photographic evidence of issues, therefore expediting their resolution. Observing issues proactively leads to fewer deviations and issues, and mitigates risks before deviations occur—offering businesses a more efficient and cost effective method for problem identification and resolution.
Trusted Audit Trails
Pharmaceutical businesses were early adopters of enterprise content management (ECM) and EIM solutions. As a result, many EIM solutions can furnish a full audit log on all information assets managed, tracked and processed within the system. When mobile applications are fully integrated with the core Solution , the activities performed by mobile users are also tracked and can be provided as evidence during audits. Many EIM platforms can organize and manage all enterprise compliance-related documents and associated processes with complete version history, automatic permissions and workflow steps.
Mobile devices give users the power to access, manage, share and process information at their fingertips, enhancing the speed and accuracy of business operations. As pharmaceutical companies embrace mobile enablement, they must be mindful to deploy solutions that safeguard compliance-related documents and processes, leveraging the benefits of going mobile while mitigating the risks.
Mika Javanainen
M-Files Corporation
Mika Javanainen is Senior Director of Product Management at M-Files Corporation. Javanainen is in charge of managing and developing M-Files product portfolio, roadmaps, and pricing globally. Prior to his executive roles, Javanainen worked as a Systems Specialist, where he integrated document management systems with ERP and CRM applications. A published author, Javanainen has an executive MBA in International Business and Marketing.
