6 Types of Data Integrity as per cGMP Document Management.

In this article, you will learn about the 6 types of Data Integrity as per cGMP FDA requirements.  Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your GMP records activities fast and easily.

Types of Data Integrity as per cGMP Document Management

There are two (2) major types of data integrity: physical integrity and logical integrity.

Both are a collection of processes and methods that enforce in both hierarchical and relational databases.  Within the logical integrity exists (4) four additional types of data integrity.

1. Physical Integrity

Physical integrity is the protection of data’s wholeness and accuracy as it’s stored and retrieved. When natural disasters strike, power goes out, or hackers disrupt database functions, physical integrity is compromised. Human error, storage erosion, and a host of other issues can also make it impossible for data processing managers, system programmers, applications programmers, and internal auditors to obtain accurate data.

2. Logical Integrity

Logical integrity keeps data unchanged as it’s used in different ways in a relational database. Logical integrity protects data from human error and hackers as well, but in a much different way than physical integrity does.

There are four types of logical integrity.

2.1. Entity Integrity

Entity integrity relies on the creation of primary keys, or unique values that identify pieces of data, to ensure that data isn’t listed more than once and that no field in a table is null. It’s a feature of relational systems that store data in tables that can be linked and used in a variety of ways.

2.2. Referential Integrity

Referential integrity refers to the series of processes that make sure data is stored and used uniformly. Rules embedded into the database’s structure about how foreign keys are used ensure that only appropriate changes, additions, or deletions of data occur. Rules may include constraints that eliminate the entry of duplicate data, guarantee that data is accurate, and/or disallow the entry of data that doesn’t apply.

2.3. Domain Integrity

Domain integrity is the collection of processes that ensure the accuracy of each piece of data in a domain. In this context, a domain is a set of acceptable values that a column is allowed to contain. It can include constraints and other measures that limit the format, type, and amount of data entered.

2.4. User-defined Integrity

User-defined integrity involves the rules and constraints created by the user to fit their particular needs. Sometimes entity, referential, and domain integrity aren’t enough to safeguard data. Often, specific business rules must be taken into account and incorporated into data integrity measures.

For more information about ALCOA for electronic records, press here.

For more information questions and answers about Data Integrity and Compliance With Drug CGMP Guidance for Industry press here.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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To see the complete list of the most popular quality procedures templates, click here.

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REFERENCES:

For more information about Data Integrity, refer to:

httpss://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance-With-Current-Good-Manufacturing-Practice-Guidance-for-Industry.pdf

TITLE 21–FOOD AND DRUGS

SUBCHAPTER A–GENERAL

PART 11  ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

httpss://clarkstonconsulting.com/insights/guidance-data-integrity/

https://www.climet.com/data-integrity/

https://www.biopharminternational.com/data-integrity-electronic-records-according-21-cfr-part-11

httpss://www.pda.org/docs/default-source/website-document-library/chapters/presentations/missouri-valley/data-integrity-issues-concernse703e9d7a8c4657391feff0000cd242a.pdf?sfvrsn=4

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://www.fda.gov/media/118202/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40

QS Regulation and Guidance • Quality System Regulation and Preamble

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Inspection Guide – Pages 8, 15, 21, 22 and 23

httpss://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm