Data Integrity
2. Inadequate user privileges to users in computerized systems
Data integrity refers to the accuracy, completeness and consistency of GxP data over its entire life cycle.
The steps involved in data integrity starts from
1. Data generation and recording - sop's for collecting data, meta data, set parameters etc.
2. Transform - controls the correct data, prevention of false data
3. Collate - verification of electronic data by chemist, verification of validated spreadsheet calculations
4. Review and report - verification by second person, verification of audit trail
5. Archive - electronic data, archival path and instant retrieval
21 CFR Part 11 Regulations
First publication on cGMP requirements are introduced by Regulatory authorities in 1963 as the Code of Federal Regulations (CFR) Part 211.2(b) This provides guidance on the importance of backups and good documentation practices like master formulas, specifications, test records, master production records and batch production records.
In 2018, FDA has published guidelines on data integrity.
21 CFR rules provides guidance on management of electronic records in pharmaceutical industries. 21 CFR Part 11 compliance however discusses on managing electronic data as well as electronic signatures.
21 CFR Part 11 regulation is important as huge electronic data is generated in the manufacturing and analytical laboratories.
21 CFR Part 11 compliance ensures that the electronic data generated are accurate, valid, reliable, confidential and is equivalent to paper documents.
One of the most importance of data integrity and security is that the electronic data generated must be accurate and consistent and will be maintained throughout its life-cycle.
In order to meet the integrity, the data must have 5 qualities based on ALCOA principle
1. Attributes - Who and When the data is generated
2. Legible - Readable and Durable data
3. Contemporary - Online data generation
4. Original - True form of the data
5. Accurate - Complete, Error free
21 CFR Part 11 Requirements related to computer usages are
1. Retention of electronic records securely and easy retrievals.
2. Use of secure electronic signatures
3. Use of validated computerized systems
4. Limited authorized access to systems and records
5. Time stamped audit trails
6. Use of device / operation checks
7. Training and qualification of users
The advanced data integrity features are
1. Documentation of instrument configuration and software
2. Automated instrument qualification
3. Secure metadata and ensure data integrity
4. Enhanced audit trail functions
5. Compliance control for unattended operations
Implementation of 21 CFR Part 11
Form a team comprising members of IT department, QA personnel and Laboratory staff
Create awareness for 21 CFR Part 11 among the users the accountability of electronic signatures
Make a master plan and SOP for risk assessment
Determine the risk category for each system as low, medium or high.
Define a priority schedule to bring all computer systems into Part 11 compliance
Prepare a procedure on Part 11 controls and requirements for each system in the laboratory
Develop an implementation plan to bring systems into Part 11 compliance
Develop procedures for limited system access to authorized people which includes a password policy
Prepare procedures for implementation of audit trails, data integrity, archiving plan
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