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21 CFR Compliance

To be 21 CFR compliant (most commonly 21 CFR Part 11 for electronic records and signatures), companies need to show that their systems and processes ensure data integrity, traceability and control. This is especially true in regulated industries like pharma, biotech, medical devices, and food and beverage.

 

How Coast Helps Customers Achieve Compliance

While regulatory compliance is ultimately achieved through a combination of software, procedures and training, Coast provides the foundation required for regulated teams to manage instrument maintenance, calibration, service documentation and operational workflows while maintaining compliant electronic records. Here are the key compliance capabilities that Coast supports:

1. Secure Electronic Records

Requirement: Structured electronic records for all maintenance and operational activities

How Coast supports it:

  • Immutable record history
  • Version tracking for record updates
  • System-generated timestamps
  • User attribution for all changes
  • Controlled record lifecycle

This ensures maintenance records remain accurate, traceable and inspection-ready.

2. Data Integrity (ALCOA+)

Requirement: Records must be attributable, legible, contemporaneous, original and accurate.

How Coast supports it:

  • Automatic user attribution on every action
  • Timestamps for all work order updates and completions
  • Required fields to ensure complete and accurate data entry
  • Digital records eliminate illegible handwriting and manual errors

3. Audit Trails

Requirement: Secure, computer-generated history of all actions and changes

All activity in Coast is automatically recorded through secure audit trails.

Audit trails capture:

  • Record creation
  • Record modifications
  • Field-level updates
  • Electronic signatures
  • Workflow status changes
  • User actions

Audit records include:

  • User identity
  • Timestamp
  • Previous value
  • Updated value

These logs provide complete traceability required during regulatory inspections.

4. Electronic Signatures

Requirement: Unique, secure and linked to records

Coast supports electronic signatures that meet the requirements of Part 11 signature attribution.

Electronic signatures are:

  • Linked to a unique user identity
  • Authenticated at the time of signing
  • Permanently associated with the record
  • Stored with timestamp and signature meaning

Typical use cases include:

  • Maintenance completion sign-off
  • Supervisor review
  • QA verification

5. Access Controls & Role-Based Permissions

Requirement: Limit system access based on roles and responsibilities.

How Coast supports it:

  • Role-based user permissions (admins, technicians, etc.)
  • Control over who can view, edit or approve records
  • Secure login tied to individual users

6. Secure User Authentication

Requirement: All regulated activities should be attributable to a specific individual.

All users in Coast are uniquely identified and authenticated.

Capabilities include:

  • Unique user accounts
  • Secure authentication controls
  • Role-based access permissions
  • Optional SSO integration
  • Session management and security controls

7. Time-Stamped Activity Records

Requirement: All regulated activities should be timestamped.

All regulated actions within Coast are automatically timestamped by the system.

Examples include:

  • Maintenance execution
  • Calibration activities
  • Record updates
  • Electronic signatures
  • Workflow approvals

System-generated timestamps ensure that records cannot be manipulated or backdated.

8. Record Retention & Inspection Readiness

Requirement: Secure storage and easy access to historical records

How Coast supports it:

  • Cloud-based storage with secure backups
  • Records are instantly searchable and retrievable
  • Maintains full asset and work order history over time
  • Audit-ready reporting
  • Data export for inspection review

9. System Validation (CSV)

Requirement: Prove the system works as intended

How Coast supports it:

  • Provides consistent, standardized workflows for repeatable execution
  • Generates reliable, timestamped records for validation evidence
  • Supports customer-led validation (IQ/OQ/PQ) with documented system behavior

Note: Customers are responsible for validating their use of Coast.

10. SOPs (Standard Operating Procedures)

Requirement: Controlled, documented procedures

How Coast supports it:

  • Attach SOPs, manuals, and instructions directly to assets or tasks
  • Ensure technicians follow procedures through checklists and workflows
  • Centralized documentation reduces version control issues

11. Change Control

Requirement: Controlled and traceable changes

How Coast supports it:

  • Audit trails capture all changes to records and workflows
  • Updates are tracked and time-stamped
  • Historical versions remain visible for review

12. Training & Accountability

Requirement: Users must be trained and accountable

How Coast supports it:

  • User-specific activity tracking ensures accountability
  • SOPs and instructions embedded in workflows support on-the-job guidance
  • Work history provides evidence of task execution and responsibility

Example Workflow Supported in Coast

Instrument Maintenance Record Lifecycle

Instrument Asset

      ↓

Scheduled Maintenance Task

      ↓

Technician Completion

      ↓

Electronic Signature

      ↓

Supervisor Review

      ↓

Audit Trail + Long-Term Record Storage

Each step produces a traceable electronic record tied to a specific user and timestamp.

 

Compliance Enablement for Regulated Operations

Coast is designed to support regulated teams across environments such as:

  • Clinical and diagnostic laboratories
  • Pharmaceutical manufacturing
  • Medical device production
  • Research and testing facilities
  • Asset-intensive regulated operations

The platform enables teams to digitize maintenance processes, improve operational visibility and maintain compliant electronic records.