Agent Inventory
Detailed listing of biological agents, quantities, storage location, and authorized personnel to support accountability and risk assessments.
Use the Biosecurity Assessment Questionnaire to document biosafety controls, prioritize corrective actions, and meet institutional or federal expectations. Electronic execution is generally enforceable under ESIGN (15 U.S.C. ch. 96) and UETA; exceptions include wills, certain court orders, and other statutory exclusions.
Primary users include biosafety officers, laboratory managers, institutional compliance teams, and external reviewers conducting risk evaluations.
Stakeholders include operations, facilities, IT, human resources, and funding or contracting officers who rely on questionnaire data for decisions.
Detailed listing of biological agents, quantities, storage location, and authorized personnel to support accountability and risk assessments.
Physical and logical access measures, badge systems, visitor policies, and role-based permissions that limit exposure to agents and data.
Documentation of required biosafety, security, and incident response training for personnel, including dates and course identifiers.
Procedures for reporting exposures, spills, theft, or other security events, plus contact points and escalation timelines.
Protocols for biological waste segregation, sterilization, disposal, and equipment decontamination to reduce cross-contamination risk.
Location and retention of SOPs, inspection logs, maintenance records, and audit trails that support regulatory review.
| Field | Configuration |
|---|---|
| Template | Create reusable form template with required and conditional fields. |
| Approval order | Set sequential or parallel routing to biosafety, facilities, then final approver. |
| Authentication | Require email and optional SMS code or advanced signer methods for high-risk items. |
| Retention policy | Automatically archive completed forms to secure records storage with retention tags. |
Choose a platform that supports PDF/DOCX uploads, secure storage, and an audit trail for all signer actions.
Submit with program startup or funding application deadlines
Conduct a full reassessment at least once per year
Update questionnaire within days after reportable incidents
Align questionnaire updates with grant reporting cycles
Respond within specified timeframe in audit notices
Collect supporting documents and complete draft responses for internal review.
Biosafety officer verifies technical accuracy and flags gaps.
Authorized official certifies and signs the final questionnaire.
Store completed form and attachments in secure records with retention tags.
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free Trial | 7-day free trial | No | No | Yes, limited | Yes, limited |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |
Optica standardized assessments across multiple sites to reduce variability and improve audit readiness.
A clinical center used the questionnaire to document lab controls for patient-safety reporting.