Regulatory Compliance & Monitoring

Import new regulations and monitor regulatory changes to maintain your library in sync and to trigger a revision workflow.

• Import new regulations through Excel import or via API
• Import regulatory changes through Excel import or via API
• The EPC will automatically generate a new draft version of your regulations, while maintaining your previous regulations
• Regulations and process owners will be notified of changes, and asked to review changes
• Approval cycle is embedded and lifecycle management allows owners to review in-text all changes that were made.

Content Security & Accountability

• Manage your content independently to ensure data safety during the entire lifecycle
• Adapt your approval workflows to embed full accountability through the lifecycle
• Review all changes, all versions of a content fragment in-text, and with visual highlighting of changes.
• Impact Analysis of all changes
• Digital signature verification on all approvals to ensure that secure identity verification (IAMS, Private & Public Keys, Vault, MHRA)
• Multi-factor authentication (MFA) supported, with for example a code being sent to your phone

FDA 21 CFR Part § 11 Compliance

• Accurate and complete copies of records for inspection throughout the records retention period
• Limit access, approvals, and use to authorized individuals and enforce permitted sequencing
• Secure, computer-generated, time-stamped audit trails to record the date of operator entries and actions
• Record changes do not obscure previously recorded information
• Secure and permanent links of all signatures with approver user and date/time information
• Signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.
• Ensures the authenticity, integrity, and confidentiality of electronic records
• Ensures that each electronic signature is unique
• Employ at least two distinct components + MFA (optional) for each signature for all
• Enforces workflows that doesn’t allow users to bi-pass two distinct component signature authentication within a single session
• Uniqueness of each combined identification code and password
• Employs transaction safeguards to prevent unauthorized use (MFA, Vault)
• Devices that bear or generate identification code or password information are tested

Content Harmonization & Change Management

• Upon publication of a regulation, notifications are issued to all content owners
• If low-impact, then publish changes after impact analysis
• Otherwise, conduct an impact analysis to evaluate impact of changes
• Determine whether impacts are Major or Minor on all connected content (processes, documents, etc.)
• Can trigger individual fragment review processes to ensure that all changes are evaluated individually
• Unless otherwise indicated, changes to downstream content is stricly controlled until the harmonization is completed, validated and approved.
• Content owners are responsible to ensure that all data is harmonized, can visually see highlighted changes and can see content that was flagged as potentially out-of-date.