Many Pharmaceutical companies struggle to ensure revenue growth due to underperforming, paper-based processes. Moreover, they deal with challenges linked to productivity, operational efficiency, compliance-related issues, and return on investment. Another notable challenge is managing mammoth data in paper systems that are hard to analyze, access, and report.
If these challenges sound familiar, it helps to rethink your present business processes and standard operating procedures. Fast-growing pharmaceutical companies are moving towards powerful, agile, and simple electronic business management systems to gain a competitive edge over their competition.
A cross-functional pharmaceutical company has departments like inventory, procurement, quality assurance, receiving, and shipping that might be uncoordinated. Most companies nowadays are embracing a paperless environment to boost operational efficiency, meet regulatory standards, cut down costs, and, most notably, maintain complete visibility. Switching to a process that appreciates electronic signatures can help adapt to the changing quality standards and make your pharmaceutical company stay current in the market.
eSignature Benefits In the Pharmaceutical Industry
Digital transformation in pharmaceutical companies is typically discussed in the context of manufacturing, production, and R&D. However, it is crucial to acknowledge that process inefficiencies can result from other areas as well, like sales, HR department, or daily operations.
Below are the benefits of implementing an eSignature tool like Foxit eSign aka eSign Genie to manage high volumes of paperwork in your pharmaceutical company.
Benefits of Electronic Signatures in The Pharmaceutical Sector
Electronic signatures are broadly recognized as an effective and modern way of obtaining signatures most industries. With the number of businesses bringing their services online, electronic signatures continue to grow in popularity.
Below, we will highlight the benefits of electronic signature in pharmaceutical company:
Efficient Regulatory Compliance for Pharmaceutical Companies
Being a pharmaceutical professional, you already know how compliance teams face a world of drug laws that are both complex and costly to manage. Pharmaceutical companies are required by FDA 21 CFR Part 11 to put controls in place, including audit trails, system validations, and documentation for systems and software involved in the electronic data processing. Corporate Integrity Agreements mandate internal processes and disclosure requirements.
Ensuring compliance requires managing a plethora of signatures from the start of the process until completion and usually includes documents, workflows, and individuals outside the corporate network. Doing so with paper and pen-and-paper signature is a burden and adds risk and cost.
Switching from wet-ink signatures to e-signatures can greatly ease the burden of compliance and allow pharmaceutical firms to easily work with consultants, physicians, and experts outside the organization. Individuals simply sign electronically, from any device, at any time. Automated reminders help ensure compliance as they notify your recipients to sign a document before it expires or become invalid. The intuitive dashboard lets you track precisely who has signed and hasn’t. Not forgetting that e-signature solutions offer complete document retention capabilities.
Streamline Clinical Tials
Pharmaceutical companies collect a sizeable number of signatures, especially during clinical trials. Directives and regulations like the 21CFR part 11 oversee signature requirements through the process, from weekly patient reviews, informed consent, electronic lab notebooks, clinical operations, and physician compliance paperwork showing that the proper protocols have been followed.
Using paper to capture signatures on all these documents tends to be costly, error-prone, and increases your risk of non-compliance. Pharmaceutical organizations thus need effective and secure alternatives to managing clinical trials.
With electronic signature in pharmaceutical, patient consent forms, weekly waivers, investigator agreements, site contracts, and consultancy agreements can all be managed electronically. Participants can complete required paperwork and electronically sign from any device: laptops, tablets, or even smartphones. This saves a lot of time.
What’s more, the forms library and document templates offered by most electronic signature software integrate with customer management systems (CRM), like Salesforce, allowing you to distribute the appropriate forms with ease. Lastly, automated reminders help ensure thorough, easy, and consistent compliance.
Easy Management and Maintenance Key Opinion Leaders (KOL) agreements
As a pharmaceutical company, no one understands your drug better than you. However, you can’t do all physician presentations and marketing by yourself. You appreciate the importance of KOLs and what they can bring to your success. From drug discovery and clinical trials to post-approval, KOLs are valuable strategic partners.
But maintaining compliance with directives like the Physician Sunshine Act and the 21 CFR Part 11 requires strict accounting of payments to these Key Opinion Leaders. Corporate Integrity Agreements, which impose specific internal compliance programs, evaluations, and disclosure obligations, make the process much more difficult. Manufacturers of pharmaceutical products and medical devices seek a KOL agreement solution that satisfies regulatory and other compliance standards with minimum costs and hassle.
electronic signature in pharmaceutical help streamline the KOL agreement process while ensuring regulatory compliance with HIPAA, 21 CFR Part 11, Physician Sunshine Act, and other regulations. Participants can register online and capture their e-signatures before an event. E-signature tools like Foxit eSign aka eSign Genie provide robust authentication features, including time stamps, digital certificates, phone-based authentication, and other levels of verification in case you need it.
The forms library and templates let you easily select the right KOL agreements. E-signatures also offer complete reporting, a comprehensive audit trail, and document retention capabilities.
Improve Pharmaceutical Sales and Sample Management
HIPAA, 21 CFR Part 11, and the Prescription Drug Marketing Act (PMDA) each have stringent requirements regarding the correct use and distribution of samples. Pharmaceutical organizations must ensure they have appropriate procedures and policies in place for compliance purposes.
They are required to monitor all samples from the moment they leave the manufacturing site until they are delivered to physician’s offices. Some pharmaceutical companies have Corporate Integrity Agreements from the Department of Health and Human Services (HHS), demanding specific internal compliance reviews, programs, and disclosure obligations. Completing these processes with wet ink signatures and paper forms is a cumbersome, time-consuming endeavor that usually overburdens pharmaceutical compliance teams and salespeople.
Using electronic signatures from Foxit eSign aka eSign Genie software can help ensure compliance when it comes to sample management. The software help mitigate risks by offering alerts about suspicious compliance issues or records involved with a contract. The form library further ensures you can always access the most recent version of the required forms or agreements. Furthermore, the Foxit eSign aka eSign Genie’s online dashboard gives you additional visibility into the process; therefore, you can see who signed what document and when.
Automating HR Processes
Like any other HR department, Pharmaceutical companies’ HR professionals are faced with signing, sending, and collecting a mountain of documents and forms. Missed signatures translate to risk for the organization. From onboarding documents to benefits enrollment to acknowledgment of organization policies, the effort needed to track and maintain these contracts is significant.
Electronic signature helps HR departments in Pharmaceutical companies make key processes like recruitment, onboarding, and benefits enrollment paperless. This saves money and time, increases compliance, reduces errors, and, importantly, enhances employees’ experience.
For instance, new hires can electronically sign NDAs and other onboarding forms. Also, HR departments can conduct 1-9 verifications and electronically manage contractor agreements.
Examples of Pharmaceutical Documents that Accept eSignature
- Clinical trial enrollment
- Patient consent forms
- R&D documentation
- Quality inspections
- New drug applications (NDAs)
- Clinical trial protocol
- Investigational new drug filings (INDS)
- Safety inspections
- Trademark registrations
- Electronic batch records
- Incident reporting
- Lot traceability
- Recall notifications
- Adverse event reporting
- Order processing
- Partnership programs
- Sales contracts
- Chain of custody
- Patient assistance program
- Simple management
- Field service reports
Legal and Compliance
- Nondisclosure agreements (NDAs)
- Patent submissions
- Standard operating procedures (SOPs)
- Trademark registrations
- Outside counsel agreements
- Internal compliance
- Purchase orders
- Master service agreements
- RFPs and bid packages
- Supplier contracts
- Vendor onboarding
- Renewal agreements
- Candidate recruitment
- New hire onboarding
- Contractor agreements
- Training compliance
- Policy acknowledgments
- Compensation agreements
- Benefits enrollment
eSignatures In Pharmaceutical Companies
Pharmaceutical companies are among the most regulated companies in the world. They are subject to strict legal scrutiny and must retain evidence of due diligence for clinical trials. Usually, the development of a new drug takes years and costs millions of dollars before licensing, with multiple stages involved.
As such, the process entails a considerable amount of paperwork. Most of this documentation is sensitive, comprises valuable intellectual property (IP), and requires to be retained for a while for regulatory purposes.
Sharing, approving, and storing documents securely used to be demanding operations. However, highly electronic signing solutions like Foxit eSign aka eSign Genie are transforming this process. Printing, scanning, photocopying, and physically storing agreements is no longer necessary. Decision-making is faster and global collaboration is made easier. Above all, compliance is easily enforceable when using eSignature solutions like Foxit eSign aka eSign Genie.