Getting Started a Data Integrity Management System (ALCOA)

In this article, you will learn how to establish a Data Integrity Management System using an ALCOA approach as per FDA requirements.  Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your training activities fast and easily.

The Data Integrity Management System is the overall process and procedures that are designed and intended to guarantee the accuracy, completeness, and consistency of data.

According to the FDA, ALCOA is the acronym used in clinical research standing for:

• Attributable,
• Legible,
• Contemporaneous,
• Original and
• Accurate

Data integrity also refers to the safety of data in regard to regulatory compliance — such as GDPR compliance — and security.

It is maintained by a collection of processes, rules, and standards implemented during the design phase.

When the integrity of data is secure, the information stored in a database will remain complete, accurate, and reliable no matter how long it’s stored or how often it’s accessed.

Data integrity also ensures that your data is safe from any outside forces.

Getting Started a Data Integrity Management System

Data Integrity Management System is the methodology of protecting data against improper maintenance, modification, or alteration.

Protecting the integrity of your company’s data using traditional methods can seem like an overwhelming task. Secure, cloud-based data integration platforms offer a modern alternative that provides a real-time view of all of your data. With industry-leading cloud integration tools, you can connect multiple source data applications and get access to all of your company’s data in one location.

It includes data authenticity.

Integrity assures the accuracy of the information, including its authenticity and trustworthiness. Information with low integrity concerns may be considered unimportant to precise operational functions or not necessary to vigorously check for errors. Information with high integrity concerns is considered critical and must be accurate in order to prevent a negative impact on University activities.

Data Integrity Management System with high relevance and concerns include:

1. The static and dynamic data entered, which must be accurate and unaltered in order to ensure proper application function.
2. The system logs, which must be accurate and unaltered in order to ensure proper detection of intrusions and system changes.

Consider the following situations when starting a Data Integrity Management System:

1. Whether data must remain accurate and uncorrupted
2. Whether data must be modified only by certain people or under certain conditions
3. Whether data must come only from specific, trusted sources

Data integrity and data availability are both factors in data’s criticality, or how essential that data is to the University’s operations.

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.

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.

For more information questions and answers about Data Integrity Management System 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 Data Integrity Management System.

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.

GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)

REFERENCES:

For more information about Data Integrity Management System, 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