What Is Not Data Integrity in Document Management?

In this article, you will learn what is not Data Integrity Management System and what is the difference between data quality and data security according to ALCOA and the 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.

Let’s start with what is “data integrity”.  It means the degree to which data are complete, consistent, accurate, trustworthy, and reliable and that these characteristics of the data are maintained to support the quality of drug products throughout their life-cycle from the point of development through commercialization.

Then, what data integrity isn’t.

With so much talk about data integrity, it’s easy for the true meaning to be muddled.

Often data security and data quality are incorrectly substituted for data integrity, but each term has a distinct meaning.

Data integrity is not data security.

Data security is the collection of measures taken to keep data from getting corrupted. It incorporates the use of systems, processes, and procedures that keep data inaccessible to others who may use it in harmful or unintended ways. Breaches in data security may be small and easy to contain or large and cause significant damage.

While it is concerned with keeping the information intact and accurate for the entirety of its existence, the goal of data security is to protect information from outside attacks. Data security is but one of the many facets of data integrity. Data security is not broad enough to include the many processes necessary for keeping data unchanged over time.

Data integrity is not data quality.

Does the data in your database meet company-defined standards and the needs of your business? Data quality answers these questions with an assortment of processes that measure your data’s age, relevance, accuracy, completeness, and reliability.

Much like data security, data quality is only a part of data integrity, but a crucial one. It encompasses every aspect of data quality and goes further by implementing an assortment of rules and processes that govern how data are entered, stored, transferred, and much more.

At CIQA, we can help you in technological aspects of achieving Data Integrity as well as the regulations (FDA, PDA, etc) for achieving data integrity compliance.

ALCOA is used by regulated industries to evaluate its compliance with data integrity and is essential to ensuring Document Control Management (DCM) and Good Documentation Practices (GDPs).

ALCOA applies to paper and electronic data.  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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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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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