I recently attended a webinar titled “10 Killer Applications for Digital Signatures in the Life Sciences Enterprise,” in which Rodd Schlerf from ARX, the maker of CoSign, discussed how various departments in a life sciences organization can make use of digital signatures.
Although the list I gathered below from the webinar is just a glimpse of the types of documents you can sign with a digital signature solution, they are, in fact, rather common.
Corporate Governance / Back Office
- Board actions
- Corporate communications
- Public reports
- Disbursements
- Payroll
- Capital appropriate approvals
- Purchasing
- Performance reviews
- Employment benefits
- Time sheets
QA and Validation Documents
- SOPs
- Work instructions
- Training records
- Requirements documents
- Specifications
- Test plans
- Validation documentation
Electronic Lab Notebooks (ELN)
- Documentation supporting research, experiments, and procedures
- Documents to enhance collaborative research teams, as well as discoveries used as legal evidence for patent applications and litigation
Lab Reports
- Certificates of analysis / authenticity
Monitoring Reports
- Site visit reports
- Site close-out reports
- Letters
Point of Sale / Service
- Periodic and annual field service reports for installed medical device equipment
- Pharmaceutical sales representative documents
Product / Patient Portals
- Patient assistance and reimbursement forms
- Financial disclosures
- Informed consents
eClinical Collaboration Portals
- Protocals
- Sample CRFs
- Informed consents
- Trial agreements
- IRB approvals
- 1572s
- Regulatory approvals and notifications
- CVs
- Financial disclosures
- Certificates of analysis
- Delegation of duties
- Training records
- Monitoring reports
- Safety letters
Electronic Batch Records (EBRs)
- Recipe
- Manufacturing instructions
- Electronic batch record
Contract Lifecycle Management (CLM)
- Contracts
- Agreements
Please join Perficient on December 11, 2014 as we deliver Implementing Digital Signatures in a FDA-Regulated Environment, a webinar in which we’ll discuss the benefits of a digital signature solution, how 21 CFR Part 11 applies to it, and what we’ve learned from implementing CoSign for our own life sciences practice.
To learn how we can help you implement a digital signature solution for your organization, please contact us today.
…all of which makes one wonder if there is a shorter list of “Documents That Life Sciences Companies CANNOT Sign With Digital Signatures.”