Documentation Standards in Research Supply Chains
The role of traceability and documentation in maintaining research integrity.
Why Documentation Matters
Comprehensive documentation is fundamental to research integrity. It enables traceability, supports reproducibility, and provides the evidence base required for peer review and regulatory compliance. For research materials, documentation creates an unbroken chain of accountability from synthesis to laboratory use.
Core Documentation Components
Certificates of Analysis (COAs)
The primary quality document for research compounds. COAs provide analytical data confirming identity, purity, and specification compliance for each batch.
Learn more about COAs →Batch Records
Detailed records of the manufacturing process, including raw materials used, equipment, environmental conditions, and personnel. These records enable root cause analysis if quality issues arise.
Material Safety Data Sheets (MSDS)
Safety documentation required for proper handling, storage, and disposal of research materials. Essential for laboratory safety compliance and emergency response.
Chain of Custody Records
Documentation tracking material handling from production through delivery, including storage conditions, shipping methods, and transfer points.
Traceability Systems
Effective traceability requires systematic identification and tracking:
- Batch/Lot Numbers: Unique identifiers assigned to each production batch, enabling complete forward and backward traceability.
- Expiration Dating: Based on stability data to ensure materials remain within specification during the labeled shelf life.
- Storage Conditions: Documented temperature and environmental requirements for maintaining quality.
- Receipt Confirmation: Documentation of material receipt in acceptable condition.
Data Integrity
All documentation should follow ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available. These principles ensure documentation reliability for regulatory and scientific purposes.
Our Documentation Practices
Accessible COAs
COAs available on product pages. Historical COAs available upon request.
Batch Traceability
Every product labeled with batch numbers enabling complete traceability to production records.
Researcher Responsibilities
To maintain documentation integrity within your institution:
- Retain COAs and shipping documentation with laboratory records
- Record batch numbers in experimental notebooks and protocols
- Document storage conditions and any deviations
- Maintain records per institutional and regulatory requirements