FDA 21 CFR PART 11 COMPLIANCE

What is Part 11

21 CFR Part 11 (Part 11) applies to electronic records and electronic signatures that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or any FDA regulation.

Official Name

US Food and Drug Administration Code of Federal Regulations, Title 21, Part 11?

Other Names

·????????21 Code of Federal Regulation Part 11

·????????21 CFR Part 11

·????????Part 11

·????????CFR Part 11

Electronic Records/Electronic Signatures

·????????Every piece of data for Clinical Trials is handled or transmitted electronically

·????????Scientifically, the integrity and non-repudiation of electronic records must be ensured

·????????Regulatory agencies inspect Sponsors, Investigators, CROs, and Vendors to ensure CFR 21 Part 11 is being met

·????????Signatures and Records are Different

o??Electronic Record is data, field, document, page

o??Electronic Signature is computer representation of a handwritten signature

·????????Ensure the integrity and non-repudiation of electronic records

·????????Allows the ability to attach signature(s) to electronic records

·????????Reduces process time and cost

?Scope of Part 11

·????????Effective since April 1997

·????????Affects databases, file storage, images

·????????Electronic data collection at Investigators, CROs, and Vendors

·????????Complexity of Auditing

·????????Data Validity

·????????Business Practices

?Components of Electronic Records

All Electronic records fall under Part 11

·????????Audit Trails (11.10e)

·????????Limited Access (11.10d)

·????????Authority Checks (11.10g)

·????????Document Controls (11.10k)

·????????Generate copies of data (11.10a-b)

·????????Operational Workflow (11.10f)

·????????Data Validity Checks (11.10h)

·????????Training (11.10i)

·????????Written Policies (11.10j)

·????????Validation of systems (11.10a)

·????????Closed system plus encryption and protection for records (11.30).

If the persons responsible for the content of electronic records also have control of system access, the system is ‘closed’. If the person responsible for content of electronic records do not have control of system access, the system is ‘open’ (i.e. internet). Open systems require the added assurance that records are protected from point of creation to receipt

Components of Electronic Signatures

Biometric (retina scans, voice recognition, fingerprint) (11.200 b)

·????????User ID/Password (11.200a)

·????????Record Binding - signature is embedded /linked to the record (11.70)

·????????Security - Controls, uniqueness, periodic checks, management, safeguards (11.300)

Approach to Part 11 Requirements

·????????Limiting system access to authorized individuals

·????????Use of operational system checks

·????????Use of authority checks

·????????Use of device checks

·????????Determination that persons who develop, maintain, or use electric systems have the education, training, and experience to perform their assigned tasks

·????????Establishment of and adherence to written policies that hold individuals accountable for actions initialed under their electric signatures

·????????Appropriate controls over system documentation

·????????Controls for open system corresponding to controls for closed system

·????????Requirement related to electric signatures

FDA 21CFR11 inspection questions

·????????Who is allowed to input data？

·????????Who is allowed to change data？

·????????How can you tell who entered the data？

·????????How do you know which data had been changed？

·????????When do you lock down the data input？

·????????Can you do the following actions？

“Show me some data, show me you can see the history of the data, show me you control the data life cycle.”

·????????Is the system validated and are the requirements met？

·????????Can you show me the results of the validation activities？

·????????Does the validation include: “Pass/fail, signature, date/time stamp”; and “objective evidence - screen prints or page printouts with a link to the direction that generated the output.”？

Part 11 Advantages

·????????Speed, audit ability and accountability

·????????Paperless records and collection and storage

·????????Data guarantees

·????????Authenticity, Data integrity, Non-repudiation, Confidentiality of records

·????????Electronic record audit trail

·????????Easy access to electronic records

Implementation of CFR 21 Part 11

·????????All systems that manage data for clinical trials need to be compliant

·????????Need to have your organization’s interpretation of Part 11 documented and how you plan to move forward with it

·????????Creation of a checklist for ensuring Part 11

·????????Don’t create documents just to meet Part 11 Make sure that you take advantage of what it does to build in data integrity??????????????

Summary

·????????Part 11 is important to all systems in Clinical Trials

o??Electronic data collection and eClinical systems

·????????Ensure all your vendors document how the system is Part 11 compliant

·????????Be prepared for audits

o??Administrative controls

o??Procedural controls

o??Technical controls

·????????Quality & integrity are key outcomes of Part 11