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.
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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 firstname.lastname@example.org.
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Three (3) Options to Create Document Control Management DCM Procedures:
Bronze Option. You Can Create Your Own Quality Procedures, using a Template.
You can download samples of the Document Control Management DCM procedure templates in .pdf format.
To see the complete list of the most popular quality procedures templates, click here.
In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.
Silver Option. We Can Bring You a Formal Training on FDA ALCOA Guidance for Data Integrity.
This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools. It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant. Request a quote now.
Gold Option. We Can Create Customized Quality Procedures.
One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.
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For more information about Data Integrity, refer to:
TITLE 21–FOOD AND DRUGS
PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
QS Regulation and Guidance • Quality System Regulation and Preamble
Inspection Guide – Pages 8, 15, 21, 22 and 23
Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]