Application of Electronic Records & Signatures in Calibration Management Software

K

kdsaggi

#1
BACKGROUND

Effective August 20, 1997, the Food and Drug Administration (FDA) issued 21 CFR Part 11, setting forth criteria under which the agency will accept, under certain circumstances, electronic records and electronic signatures as equivalent to paper records and handwritten signatures. Part 11 allows firms to take advantage of electronic technology, and to have electronic records considered equivalent to traditional paper records.
Such systems will need to be validated to ensure accuracy, reliability, and consistency, and they will need security checks and audit trails to verify that records are accurate and that changes are recorded. Electronic signatures are subject to additional requirements, to ensure that a signature can only be used by its genuine owner, and that the act of signing a document electronically is equivalent to a traditional handwritten signature.
Calibration Management Software (CMS) is database software designed specifically to help companies meet the calibration record-keeping requirements of 21 CFR Parts 211 and 820. Many Commercial Off The Shelf (COTS) software packages are available. The features and specifications of CMS that help ensure compliance with Parts 211 and 820 will also simplify compliance with Part 11. These features include password-based
security and time-stamped audit trails. In addition, the software should include an Electronic Signature feature designed to help meet the requirements set forth in Part 11.
The cGMP’s state in numerous instances that records of calibration and maintenance information must be maintained, and these records are subject to document controls that include, among other things, signatures of the reviewing or approving party.
Record Requirements The following are just some of the instances where calibration and maintenance records are mentioned in the cGMP’s.
• Complete records shall be maintained of the periodic calibration of laboratory
instruments, apparatus, gauges, and recording devices…. [211.194(d)]
• Records shall be kept of maintenance, cleaning, sanitizing, and inspection as
specified…. [211.67(c)]
• Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented. [820.72(a)] In light of the regulations reviewed above, and other FDA regulations, CMS should be designed so that users may electronically sign each Equipment History record, and any
changes to those records. The electronic signature must be initiated by the user logged onto the CMS.
Because the use of electronic records and electronic signatures is not required by Part 11, the software does not require the use of electronic signatures. To help users comply with the requirements of Part 11, it is recommend that you establish procedures to ensure that each Equipment History record and each change to those records is signed by the
responsible or approving party.

OVERVIEW OF CMS FEATURES FOR PART 11 COMPLIANCE

CMS software should be designed specifically to help users meet the requirements of the Current Good Manufacturing Practices set forth in Parts 211 and 820. In addition, the software should includes features designed to help users meet the requirements of Part 11, Electronic Records and Electronic Signatures. Some of these features include:
• Security
• Audit Trail
• System & Database Logs
• Equipment History Records
• Electronic Signature Button
• Electronic Signature Log
• Validation and Procedural Documentation Security

The software should feature a multiple-level, password-based security system that allows an organization to limit system, database, and record access to authorized users. System administrators can, if desired, further limit authorized users’ rights to add, edit, delete or even view records. If an organization is using multiple databases (for instance, one for production instruments and one for R & D), a user can be granted different rights to each
database.
Audit Trail The software should feature an audit trail to track changes made to the system data. The audit trail records the date and time of a change, as well as the original field value and the changed field value. When password security is used, the audit trail also records the name of the user making changes and the reason for the change. Each record has its own audit trail record. In addition to the audit trail records for each Equipment Master and Equipment History record, the software should maintain logs that reflect changes to each database and to the system as a whole. These logs are similar to audit trail records, in that they will record an activity, its date and time, and the ID and name of the user responsible for the change. History Records The CMS should record a separate history record for each activity performed on a piece of equipment. For instance, there is a record of each calibration performed on an instrument. In addition, if users track maintenance, inspections, etc., there will be a history record for each of these activities. The history record includes the date of the activity, and can include who performed the activity, comments, approvals, and measurement data. If the electronic signature feature is used, the history record will also
include the electronic signature of a user, so that each calibration (or maintenance, etc.) record will be linked to an electronic signature specific to that record.
Electronic Signature The software should offer an electronic signature mechanism. When a user selects this mechanism, an Electronic Signature dialogue box will appear, prompting the user for the User ID and a password. To electronically sign a record, the user will have to enter information into both of these fields. As indicated in Part 11, when a user signs additional records in a single, continuous period of controlled system access, the User ID field will be filled, and the user will be prompted for a password. When the User ID and password have been entered, the user will be prompted for a meaning for the signature (for instance, Review, Approval, Responsibility, or Authorship). Upon completion of a signature, a Confirmation Box will appear. Each electronic signature and its reason will be linked to a specific history record. Electronic Signature Log An electronic signature log should be made available. The electronic signature log displays the date and time that the signature was executed, as well as the User ID and User Name of the person signing the record, and the reason for the signature. This information is also recorded in the record’s audit trail.

Validation Documentation


Section 11.10 of Part 11 requires persons using closed systems (like COTS Calibration Management Software) to employ procedures and controls to ensure the authenticity, integrity, and confidentiality of electronic records and electronic signatures. One such control is the validation of systems to ensure accuracy, reliability, and consistent intended performance.
The vendor should be able to provide both validation protocol and software quality assurance documentation.

CONCLUSION

By covering the many aspects of Part 11 and proper selection, implementation and validation of the software it is possible to have a Part 11 compliant Calibration Management System.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
J Has the facility been inspected? question in Certificate to Foreign Government application Other US Medical Device Regulations 0
Cats Clause ISO 9001:2015 7.1.5 Monitoring and measuring resources: Application to training providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Can you import medical device not FDA approved into the USA under an IND application? US Food and Drug Administration (FDA) 2
E Do I need test reports for all standards mentioned in my 510k application? Other Medical Device Related Standards 8
S Taiwan QSD application Other Medical Device Regulations World-Wide 1
shimonv Where do you place Human Factors report in a 510(k) application? Other US Medical Device Regulations 3
Jessesun The application of ozone sterilization in medical treatment US Food and Drug Administration (FDA) 0
L API Q1 Application Oil and Gas Industry Standards and Regulations 2
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
D Dental application - medical product or not? Other US Medical Device Regulations 8
T Including a class 1 camera in the 510k application of class 2 therapeutic technology? US Food and Drug Administration (FDA) 18
shimonv Can you submit a traditional application for a class I device? Other US Medical Device Regulations 7
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 2
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
G Application to Chartered Quality Institute - MCQI ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 4
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
U GMDN CODES application ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
R CAMBODIA - Application of AMDD Other Medical Device Regulations World-Wide 3
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P SOUP anomaly evaluation for MMA (Mobile Medical Application) IEC 62304 clause 7.1.3 IEC 62304 - Medical Device Software Life Cycle Processes 6
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
Cats Clause ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational EU – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Medical Device and FDA Regulations and Standards News 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
Sidney Vianna Informational ISO 18091 - Guidelines for the application of ISO 9001 in local government Other ISO and International Standards and European Regulations 1
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
D I'm new in IMDS special using the IMDS application Manufacturing and Related Processes 8
M Medical Device News NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” Medical Device and FDA Regulations and Standards News 0
S IATF 16949 9.1.1.3 Application of statistical concepts - Our technicians are quizzed for statistical knowledge IATF 16949 - Automotive Quality Systems Standard 3
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
M Some possible misunderstandings on the application of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
K Need feedback: FMEA Web Application FMEA and Control Plans 5
I FAR Part 43 and Application to 17025 Accredited Cal Lab Federal Aviation Administration (FAA) Standards and Requirements 2

Similar threads

Top Bottom