Quality and records — Do quality standards in many industries permit properly controlled electronic documents to serve as permanent records (e.g., with audit trails, access control, and retention policies)?

Introduction / Context:
Quality management systems depend on reliable records. With digital transformation, standards and company policies often recognize electronic documents as official records—provided controls ensure authenticity, integrity, and retrievability over the retention period.

Given Data / Assumptions:

• Claim: properly controlled electronic documents can be permanent records.
• Controls include versioning, audit logs, security, and backups.
• Applies to drawings, procedures, test data, and approvals.

Concept / Approach:
The key is control, not media. Systems that enforce access rights, track changes, provide time-stamped approvals, and preserve records in durable formats meet the intent of quality standards. Electronic signatures and immutable audit trails provide traceability equal to or better than paper, and retention plans ensure long-term availability.

Step-by-Step Solution:
1) Identify record requirements: authenticity, integrity, availability.2) Map controls: EDMS/PLM provide controlled change, approvals, and metadata.3) Validate retention: backups, archives, and file-format strategies cover longevity.4) Conclude that properly controlled electronic documents qualify as permanent records.

Verification / Alternative check:
Internal and external audits commonly accept controlled electronic records when policies and systems demonstrate adequate safeguards and traceability; many organizations are paperless for engineering documents.

Why Other Options Are Wrong:

• Incorrect: Ignores widely adopted digital record practices.
• Drawings only / paper originals only / short-term only: Controls, not document type or age, determine acceptability.

Common Pitfalls:
Relying on uncontrolled network folders; lacking retention schedules; failing to validate file readability over time; insufficient backup and disaster recovery planning.

Final Answer:
Correct