Clinical Trials Computer Systems
Guidance and Regulations
Part 11 of Title 21
Background
Regulations for acceptance by FDA of:
• Electronic records
• Electronic signatures
• Handwritten signatures executed to
electronic records
Application of FDA Guidance
FDA guidance applies to:
• Computerized data management systems for
data required by the FDA
• Transmission of clinical data required to be
submitted to the FDA
• Training of personnel
• Internal/ external security safeguards
• Source documentation and retention
• Standard operating procedures for data
security
Who is Subject to Part 11?
Persons who have chosen to maintain
records or submit designated information
electronically, e.g., Current Good
Manufacturing Practice (CGMP)
Computer Systems for Clinical Trials
• Laboratory Information Management Systems
(LIMS)
• Systems that automatically record data by
integrating data from another source like an
EMR
• Electronic Case Report Forms
• Electronic Patient Reported Outcomes
• Adverse Event Reporting Systems
LIMS
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21 CFR part 11 compliant as required
Sample tracking
User certification
Full auditing, audit trail features
Reporting
Sample scheduling
Bar coding
LIMS
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Sample and data management
Test sample flow during QC
Improved data analysis
Data trending and reporting
Track and manage laboratory testing
activities
• Track samples through the laboratory
workflow
System Validation
Controls and Requirements
• System Validation
o
Device meets all requirements and user expectations
• Security
o
Limit system access to authorized individuals
• User requisites: education, training, and
experience
• Written policies that hold individuals
accountable for actions initiated under their
electronic signature
Electronic Records
• What:
– Records that are required to be maintained in
electronic format in place of paper format
– Records that are relied on to perform regulated
activities
– Records submitted to the FDA in electronic format
– Electronic signatures equivalent of handwritten
signatures, initials, and other general signing
• Why
– To document events and actions required by
predicate rules (e.g., approved, reviewed, and
verified)
Signature Methods
Accepted by the FDA
• Scanned signatures
• Digital signatures
• Flattened digital signatures. A flattened
digital signature must include:
o the printed name of the signer
o the date and time when the signature was
executed
o the reason for signature
Electronic Signature
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Generated by applying each person’s network
profile identification
Standard signature process including at least two
components (identification code and password)
Each signature has to be unique to one individual
It has to be certified
Cannot be reused or reassigned to another
individual
Must be linked to its respective record
Conclusions
The purpose of FDA’s regulatory
requirements and guidance is to:
• Guarantee that electronic records used
in drug manufacturing are accurate,
complete, and current
• Ensure that reliable data is used to
sustain a product’s safety and
effectiveness
Thank you!