Standard Operating Procedure: Good Documentation Practices (GDP)

Purpose and Scope

Good Documentation Practices (GDP) are essential to ensure the integrity, reliability, and traceability of data across all operational workflows. This SOP defines the mandatory requirements for recording, managing, and maintaining documentation to meet regulatory standards and internal quality assurance goals. This policy applies to all personnel responsible for generating, reviewing, or archiving documentation, whether in hard-copy or electronic format.

Phase 1: General Documentation Principles

• ALCOA+ Compliance: Ensure all data is Attributable, Legible, Contemporaneous, Original, and Accurate (plus Complete, Consistent, Enduring, and Available).
• Use of Approved Ink: All manual entries must be made using permanent, non-fading, black or blue ink. Pencil, erasable ink, or felt-tip markers are strictly prohibited.
• No Obscuring Data: Never use correction fluid (e.g., White-Out), tape, or over-writing to mask information. If an entry is incorrect, a single line must be drawn through it, leaving the original entry legible.
• Documentation Speed: Record all data at the time the action is performed. Backdating or "provisional" recording is a violation of data integrity.

Phase 2: Correcting Errors

• The Single-Line Strike: Draw a single line through the incorrect information so it remains visible.
• Correction Justification: Write the reason for the correction next to the mistake (e.g., "clerical error," "transposition error").
• Audit Trail: Initial and date the correction.
• Authentication: If the person correcting the entry is not the original author, note the relationship and ensure the correction is co-signed by the party responsible for the original data.

Phase 3: Electronic Documentation and E-Signatures

• Unique Credentials: Never share system login credentials. Every user must have a unique ID and password.
• System Integrity: Only use validated software systems for recording operational data. Ensure all electronic signatures are mapped to the specific user account.
• Time-Stamping: Ensure the system clock is synced with the official company time server to ensure accurate, automated time-stamps.
• Backup Protocols: Confirm that all electronic records are automatically saved to a redundant, secure, and backed-up server.

Phase 4: Review and Archiving

• Second-Person Review: All critical documentation must undergo a peer review to verify data accuracy and procedural adherence before final submission.
• Page Integrity: In bound logbooks, do not remove pages. If a page is damaged, document the reason and attach the damaged piece to the log.
• Storage Conditions: Physical documents must be stored in a climate-controlled, fire-rated, and access-controlled environment to prevent degradation.
• Retention Schedules: Adhere strictly to the company’s Master Retention Schedule; do not destroy documents before the minimum legal retention period has expired.

Pro Tips & Pitfalls

• Pro Tip: Treat every document as if it will be audited by an external regulator tomorrow. If it isn't documented, it didn't happen.
• Pro Tip: Use "N/A" for empty fields. Leaving a field blank creates ambiguity regarding whether the data was missed or simply not applicable.
• Pitfall - The "Batch Entry" Trap: Avoid waiting until the end of the day to record activities. Memories fade, and the "Contemporaneous" requirement of ALCOA+ is violated.
• Pitfall - Illegible Signatures: If your signature is merely a squiggle, ensure your printed name or a digital signature stamp is present for identification purposes.

FAQ

Q: Can I use correction tape if I rewrite the information neatly over it? A: No. Correction tape completely obscures the original entry, which prevents auditors from seeing the history of the data. This is a critical data integrity violation.

Q: What should I do if I run out of space on a page for a log entry? A: Do not crowd the margins. Use an official "continuation sheet," reference the original document, and ensure the continuation sheet is physically attached or digitally linked to the parent record.

Q: Are "ditto marks" (") allowed to save time when repeating entries? A: Absolutely not. Ditto marks are prone to misinterpretation and do not meet the standard of clear, unambiguous documentation. Every entry must be written out fully.