records

In industrial and regulated manufacturing environments, records are documented evidence of activities, decisions, or results. They capture what actually happened in a process, system, or organization at a specific point in time.

Records can be paper-based, electronic, or a combination of both. They are typically created during normal operations and then retained for a defined period to support traceability, investigations, audits, and regulatory reviews.

What records usually include

Depending on the process and industry, records commonly include:

• Production and batch records (e.g., materials used, equipment, operators, timestamps)
• Quality and test records (e.g., inspection results, deviations, nonconformances, CAPA actions)
• Maintenance and calibration records (e.g., work orders, calibration results, service reports)
• Training records (e.g., who was trained, on what content, and when)
• Change and configuration records (e.g., change requests, approvals, implementation details)
• IT/OT system records (e.g., audit trails, access logs, event logs, backup logs)

Records vs documents

In many quality and compliance frameworks, a distinction is made between:

• Documents: Describe what should be done (procedures, work instructions, specifications, policies).
• Records: Show what was actually done and what results were obtained (completed forms, logs, signed checklists, electronic audit trails).

Both can exist in the same system, but records are frozen once created and are not edited in the same way as controlled documents. Corrections to records are usually traceable and reasoned, rather than replacing the original entry.

Operational role of records

In manufacturing systems and integrated IT/OT environments, records are generated and stored across multiple platforms, such as MES, ERP, LIMS, QMS, maintenance systems, and data historians. Operationally, records are used to:

• Demonstrate conformity to specifications, procedures, and standards
• Support batch release and product disposition decisions
• Enable root cause analysis, CAPA, and continuous improvement activities
• Provide evidence during internal and external audits or inspections
• Support traceability and genealogy of materials, equipment, and product

Records in the context of standards

Many standards, including ISO-based quality and management system standards, use the term “records” to refer to retained documented information that provides evidence of results. These standards typically specify what records must be kept, how long they should be retained, and at a high level how they should be controlled, protected, and retrievable.

Common confusion

• Records vs raw data: Raw sensor or process data becomes a record when it is captured, associated with context (for example, time, equipment, batch), and retained as evidence. Not all transient data is treated as a formal record.
• Records vs reports: A report is often a compiled or summarized view of underlying records. The source records are usually the primary evidence.

Related manufacturing examples

• A completed electronic batch record (EBR) in an MES that logs each step, material lot, and sign-off.
• A calibration record showing when a scale was calibrated, by whom, what standard was used, and the results.
• An audit trail record in a QMS showing who changed a specification and when.