Record Retention
Table of Contents
Introduction
Record retention refers to the processes and policies surrounding the systematic creation, storage, maintenance, and disposal of records within an organization to meet legal, regulatory, and business requirements. In the life sciences, pharmaceutical, and biotech sectors, effective record retention is critical to ensuring compliance, supporting research and development, and ensuring patient safety.
Definitions and Concepts
- Retention Schedule: A predefined timeline outlining how long specific records must be kept based on their type and regulatory requirements.
- Archiving: The process of transferring inactive records to secure, long-term storage to preserve their integrity and accessibility.
- Destruction: The secure and permanent disposal of records that have exceeded their retention period and are no longer required.
- Electronic Records: Any records stored in a digital format, such as laboratory data, clinical trial results, or compliance documents.
- Audit Trail: A chronological record that traces the creation, modification, or deletion of a document, ensuring accountability and compliance.
Importance
In the life sciences, pharmaceutical, and biotech industries, record retention serves several critical functions:
- Regulatory Compliance: Meeting guidelines from agencies such as FDA, EMA, or WHO, which mandate specific record retention durations for quality, safety, and efficacy documentation.
- Legal Protection: Retaining records to support legal defense in cases of product liability, intellectual property disputes, or compliance investigations.
- Continuity of Research: Preserving historical data to support ongoing research, replicate results, or comply with clinical trial standards.
- Quality Assurance: Ensuring all production, testing, and compliance data are properly archived to maintain product integrity.
- Patient Safety: Having quick access to records during product recalls, adverse event investigations, or regulatory reviews.
Principles or Methods
Effective record retention for these industries is guided by several best practices and methodologies:
- Classification: Categorize records by type (e.g., clinical, regulatory, manufacturing, or financial) to determine appropriate retention periods.
- Retention Policies: Develop clear written policies detailing the handling, storage, and disposal of records in compliance with ISO 13485 and other relevant standards.
- Secure Storage: Use validated systems to store records in tamper-proof formats, including electronic record management systems (ERMS) for digital data.
- Periodic Audit: Conduct routine audits to ensure compliance with both internal policies and external regulatory requirements.
- Data Integrity: Ensure that all records are accurate, attributable, legible, contemporaneously created, original, and complete (following the ALCOA principle).
- Retention Periods: Adhere to industry-specific timelines, such as 25 years for clinical trial data or lifetime retention for medical device records.
Application
Record retention practices play a pivotal role in several areas within the life sciences, pharmaceutical, and biotech sectors:
- Clinical Trials: Retaining patient data, protocols, and study results for mandated periods to support regulatory filings and inspections.
- Drug Development: Maintaining documentation for Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP).
- Regulatory Submissions: Ensuring that documentation required for Investigational New Drug (IND) or Marketing Authorization Applications (MAAs) is available and compliant.
- R&D Operations: Storing research data to reproduce experiments, uphold IP claims, or support product development continuity.
- Pharmacovigilance: Ensuring adverse event reporting and corrective actions are documented for accountability and patient safety.