Safe and traceable data management is provided in applications such as pharmaceutical manufacturing, biotechnology, health management, and medical institutions.
Make managing setting change history easier and more efficient in pharmaceutical production, quality assurance, and biopharmaceutical development!
The SMARTDAC+ GX/GP/GM Advanced Security option (/AS) provides safe and traceable data management in applications such as pharmaceutical manufacturing, biotechnology, health management, and medical institutions. The Advanced Security function supports the strict requirements of US FDA 21 CFR Part11, EU-GMP Annex11 and other associated guidelines for data management. It also supports data integrity in accordance with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) mentioned in PIC/S, WHO, MHRA and FDA guidance documents.
Pharmaceutical Regulations
- What is data integrity?
- What are electronic records and electronic signatures?
FDA21 CFR Part11
EU-GMP Annex11
ER/ES guideline
Details for Products That Comply with Pharmaceutical Regulations
What Is Data Integrity?
Due to the increasing number of findings during inspections related to data falsifications and misconduct concerning data integrity, regulatory authorities such as the FDA (U.S. Food and Drug Administration) and MHRA (UK Medicines and Healthcare products Regulatory Agency) are strengthening their oversight of data integrity and continuously issuing guidance.
Guidance
| Publication Date | Institution | Guidance Name |
|---|---|---|
| December 2018 | FDA | Data Integrity and Compliance with Drug CGMP: Questions and Answers |
| March 2018 | MHRA | ‘GXP’ Data Integrity Guidance and Definitions |
| July 2021 | PIC/S | GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS |
| October 2021 | WHO | Guideline on data integrity |
*As of May 2025
The fundamental principles of data integrity, known as “ALCOA+” - Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available – have been adopted across these guidance documents.
ALCOA+ Principles of Data Integrity
| Attributable | It must be clear who created the data. |
|---|---|
| Legible | Data must be legible to anyone. |
| Contemporaneous | Data must be recorded at the time of measurement. |
| Original | Copied data must be identical to the original data. |
| Accurate | Data and results must be accurate without any errors. |
| Complete | All necessary information must be available to reconstruct the situation. |
| Consistent | Data must be consistent and contain no contradictions. |
| Enduring | Data must be available during the retention period. |
| Available | Data must be accessible at any time during the retention period. |
What Are Electronic Records and Electronic Signatures?
When using electronic media for records and signatures in the manufacturing and development of pharmaceuticals, there are requirements to ensure that electronic records and signatures are equivalent to traditional paper records and handwritten signatures. There requirements are defined respectively in the three major regions: the United States, Europe, and Japan.
FDA 21 CFR Part11
Established by the FDA in 1997, this regulation sets forth the requirements for electronic records and electronic signatures to be accepted as equivalent to paper records and handwritten signatures. The text of Part11 is divided into three sections: Subpart A, Subpart B, and Subpart C.
| Composition | Content |
|---|---|
| Subpart A: General Provisions §11.1 Scope §11.2 Implementation §11.3 Definitions |
Provides definitions of terms used in relation to electronic records subject to 21 CFR Part 11. |
| Subpart B: Electronic Records §11.10 Controls for closed systems §11.30 Controls for open systems §11.50 Signature manifestations §11.70 Signature/record linking |
Provides the requirements and procedures for using electronic records. |
| Subpart C: Electronic Signatures §11.100 General requirements §11.200 Electronic signature components and controls §11.300 Controls for identification codes/passwords |
Provides the requirements for using electronic signature. Because individual identification is required, the clause applies even when electronic signatures are not utilized. |
Refer to eCFR :: 21 CFR Part 11 -- Electronic Records; Electronic Signatures
To summarize the provisions, the main requirements for the device or system are as follows.
EU-GMP Annex11
The EU pharmaceutical regulations consist of Volumes 1 through 9. Volume 4 covers GMP (Good Manufacturing Practice). GMP includes supplementary documents known as “Annex,” and Annex 11 summarizes the requirements related to computerized systems and their use. Annex 11 has been issued as the common EU guideline for CSV (Computerized System Validation). The main system requirements can be summarized as follows.
- Ensuring data accessibility, readability, accuracy, and preservation
- Audit trail (records of changes and their reasons)
- Security (physical and logical access control)
- Configuration, methods, and management of electronic signatures
Ministry of Health, Labour and Welfare ER/ES Guideline
This guideline, issued on April 1, 2005 by the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour, and Welfare, outlines the requirements for the use of electromagnetic records (electronic records) and electronic signatures in the approval or licensing of pharmaceuticals and related products. The main requirements for the devices and systems involved are summarized as follows:
- Ensuring the authenticity, legibility, and preservation of electronic records
- Audit trails (ensuring authenticity and recording of operations)
- Security (ensuring authenticity and identification of the signer)
- Structure, method, and management of electronic signatures
The ER/ES Guidelines set forth requirements that are essentially the same as those of Part 11. The guidelines state that “the reliability of electronic record systems is assumed to be ensured through computer system validation (CSV).”
SMARTDAC+ GX/GP/GM Main Functionality
SMARTDAC+ GX/GP/GM with Advanced Security Function is designed to comply with each guidance through the following functions, among others.
Audit Trail Function
Operation log is saved to a file along with measurement data. When settings are changed, it is possible to record the reason for the change along with the setting change operation. In addition, it is possible to confirm the details of the setting change from the Show difference of the setting difference.
Logical Security
SMARTDAC+ has four main security levels (two separate administrator roles, user and monitor user). Up to 200 persons can be registered. Access privileges can be assigned separately to each second administrator and user. Process owners/ system owners can be given access rights to functionality appropriate to their role.
Administrators with appropriate privileges can set and register other users’ login information and access privileges. For each user, the user name, user ID, password and password expiration period can be set. For the password, a minimum string length and minimum policy complexity can be set. Centralized management of user names and passwords using servers on the network is possible through Active Directory.
Electronic Signature
Measurement data can be displayed and confirmed on the GX/GP or the SMARTDAC+ Standard Universal Viewer software, and an electronic signature can be applied to that data. Three levels of signature are available: operator, supervisor and quality control. The signature along with information such as pass/fail and comments can be saved to the data for review and audit.
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Product lineup with the Advanced Security function
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Touch Screen GP10/GP20
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Touch Screen Paperless Recorder GX10/GX20
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