A record is simply a completed document that provides empirical evidence that a process was followed.

Records must be controlled so that they are preserved and not adulterated.

Every organization needs a procedure for their records management program.

The procedure needs to include how records are

• Identified
• Stored
• Secured
• Integrity Maintained
• How long they are retained
• How they are dispositioned

While most organizations these days will utilize an electronic system for document controls, records are often still paper based.

Even if the organization invests in electronic manufacturing solutions, executed qualification protocols, pest control reports, and other sub-contacted activities will often be paper-based.