Gain the latest insight (2013) into 21 CFR Part 11 Compliance from AITalent's latest Webinar.
Discover:
Part 11 – What it is not, the myths.
Part 11 – What it is, the facts.
Part 11 – What does the future hold?
Find out more: www.aitalent.co.uk
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Complying with 21 CFR Part 11 - Understanding the role of predicate ruleJasmin NUHIC
To obtain knowledge and understanding of 21 CFR Part 11 as how it applies to you as well as be advised of consequences which may result in failing to comply with this regulation.
This presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that establishes requirements for electronic records and electronic signatures in the context of FDA-regulated industries, including pharmaceuticals, biotechnology, medical devices, and food and beverage. The regulation is titled "Electronic Records; Electronic Signatures" and is intended to ensure the reliability, integrity, and authenticity of electronic records and signatures used in FDA-regulated activities.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Complying with 21 CFR Part 11 - Understanding the role of predicate ruleJasmin NUHIC
To obtain knowledge and understanding of 21 CFR Part 11 as how it applies to you as well as be advised of consequences which may result in failing to comply with this regulation.
This presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that establishes requirements for electronic records and electronic signatures in the context of FDA-regulated industries, including pharmaceuticals, biotechnology, medical devices, and food and beverage. The regulation is titled "Electronic Records; Electronic Signatures" and is intended to ensure the reliability, integrity, and authenticity of electronic records and signatures used in FDA-regulated activities.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
In the work from home era, we all realized how important it is to digitize our important documents and what a lifesaver digital signatures are. With everything now getting electronically stored, electronic signatures and documentation are slowly replacing the paper-based system. That means we must now get ready to expand our digital storage plans rather than buying new filing cabinets...
Excel spreadsheets how to ensure 21 cfr part 11 compliancecomplianceonline123
Learn to create a GxP compliant Excel spreadsheet application. Understand how to validate Excel spreadsheets with minimal documentation. Learn to configure Excel for audit trails, security features, and data entry verification.
21 CFR Part 11, commonly referred to as “Part 11” is a set of rules that specifies what is required for electronic records and signatures. The regulatory framework outlines the management of records in Electronic Quality Management Systems for Life Science and other FDA-regulated industries.
Why is it called 21 CFR Part 11?
What is 21 CFR Part 11? CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.
What are the 21 CFR rules?
21 CFR Rules set out guidelines on the usages and management of electronic records as well as electronic signatures. As such, as the user of electronic data records, you are guided by 21 CFR rules so that you can have optimal benefits from the data and also act in integrity.
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.
(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.
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The FDA published 21 CFR Part 11 in 1997 to regulate electronic records and electronic signatures. Technology has advanced considerably since 1997, but the regulation still applies and is more critical than ever. Due to the COVID-19 pandemic and most firms transitioning to remote work, companies need to make sure that their system is compliant with the regulation. Once a QMS record is scanned, uploaded to a server, or otherwise electronically stored it automatically falls under the scope of 21 CFR Part 11 despite there also being a paper record...
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21 CFR Part 11 Compliance
1. 21 CFR Part 11 Compliance
Webinar
Stephen Gibney | Bruce Walcroft
2. • Introductions
• Part 11 –
– Exploring the Myths
– Revealing the Facts
– What Does the Future Hold?
• Validation Requirements
• Live Examples
• Questions
Agenda
21 CFR Part 11 Compliance
3. Stephen Gibney (sgibney@aitalent.co.uk)
• Quality & Document Manager @ AITalent.
• Previously,
• Software Quality Assurance Manager at SPD,
(Clearblue Product Range, Smartcheck INR),
• QAV Specialist in biopharmaceutical manufacturing
control systems, (Enbrel/Pravner),
• Software Engineer in financial and telecoms software
development (Personal Finance & SMSC, 3g network
performance monitor systems)
Please allow me to introduce myself
21 CFR Part 11 Compliance
uk.linkedin.com/in/
stephengibney
4. • Myth 1 – Every computer system/software used
in the life science industry comes under the remit
of part 11.
• Not all software used in life science industries is
Part 11 regulated.
– First ask, is the software used for a Quality or
Production system? If not then Part 11 does
not apply. e.g. Payroll software is not part 11
regulated.
Part 11 What it is not - The “Myths”
21 CFR Part 11 Compliance
5. • Myth 2 – all Quality & Production systems need
to be Part 11 compliant,
• First ask, are records retained, signed or
submitted electronically?, if not then Part 11
does not apply to the system.
• If the master record is retained in paper format
then Part 11 does not apply.
Part 11 What it is not - The “Myths”
21 CFR Part 11 Compliance
6. • Myth 3 – It applies to every single piece of
processing equipment/sub-system.
• First ask, does the system hold all of the record?
• If a system only generates part of a record or
meta data and transmits this record part to a
higher level system then the lower level system is
not Part 11 and the higher level system that holds
the complete record is the Part 11 system.
• Example Meta Data System,
• PLC, microcontroller, etc…
Part 11 What it is not - The “Myths”
21 CFR Part 11 Compliance
7. • Myth 4 - all computerised systems that keep electronic
records must be made to be part 11 compliant.
• If the system does keep electronic records but it is
older then 1997, then it can be deemed to be a legacy
system and Part 11 may not apply.
• FDA employs enforcement discretion for legacy
systems.
• Example Legacy Systems
– Manufacturing Systems implemented prior to
1997.
– Careline systems implemented prior to 1997.
Part 11 What it is not - The “Myths”
21 CFR Part 11 Compliance
8. • Myth 5 – Part 11 applies to Medical Device Software
• Medical device software, either embedded in a
medical device or software that is a medical device in
it’s own right is not Part 11.
• However, software that is used to calibrate, service or
maintain a medical device maybe Part 11, as this
software is used for a quality purpose. e.g. complaint
investigation software.
Part 11 What it is not - The “Myths”
21 CFR Part 11 Compliance
9. • Myth 6 – Part 11 is only about technical controls for
the Computerised Systems within the Life Science
Industry.
• There are several procedural controls within Part 11
that must be implemented by companies using Part 11
systems.
Part 11 What it is not, the “Myths”.
21 CFR Part 11 Compliance
10. Part 11 - Revealing the Facts
21 CFR Part 11 Compliance
11. • What does it mean?
– 21 – Chapter of US Federal Law – Food, Drug
& Cosmetics Act circa 1906,
– CFR - Code of Federal Regulation – US Federal
Government Law,
– Part 11 – That part of 21 CFR that deals with
electronic records & electronic signatures.
21 CFR Part 11 - ????
21 CFR Part 11 Compliance
12. • U.S. Federal Regulation to ensure electronic
records are trustworthy,
• Part 11 applies to all FDA regulated industries,
where electronic record keeping, signing and
submitted is used for systems with a Quality
and/or Production purpose that where
implemented post 1997.
What is Part 11
21 CFR Part 11 Compliance
13. Paper Record Change
Electronic Record Change
• Five score and seven years ago our fathers
brought forth on this continent, a new nation,
conceived in Liberty, and dedicated to the
proposition that all men are created equal.
Paper vs. Electronic Record Changes
21 CFR Part 11 Compliance
14. • Created in 1997 due to the increasing adoption of
computerised electronic keeping in life science
industry and concerns with the integrity and
robustness of electronic records at that time.
• Enforced by the Food & Drug Administration FDA.
• PART 11 applies to all Drug and Medical Devices
manufacturers that sell into the United States
and use electronic records & electronic
signatures.
21 CFR Part 11 - a brief history
21 CFR Part 11 Compliance
15. The current Part 11 covers;
– Electronic Record Keeping – any quality or
production record held electronically.
– Electronic Signatures - any approval of a quality or
production record that is committed electronically.
– Electronic Submissions -
NDAs, 510(k)s, PMAs, etc…
Scope of Part 11?
21 CFR Part 11 Compliance
16. Electronic Record,
• Any record required for a Quality or Production
purpose that is held electronically.
• e.g. Batch Records, Training Records, Customer
Complaint Records, etc…
What are Electronic Records?
21 CFR Part 11 Compliance
17. Electronic Signature,
• Comprised of two parts,
• First part - publically known identifier
• Second part - known only to the owner of the
esig,
• First part is typically a username to identify the
user uniquely and trace to their job role and
training record to verify that their authority level
and competence to sign for that job role.
• Second part is typically a Password (can be
biometric data) to ensure that it is actually the
right person signing.
What are Electronic Signatures?
21 CFR Part 11 Compliance
18. • Quality and Production paper records are legal
documents they can be and often are submitted
as evidence in legal proceedings,
• Altering/tampering with a paper record is fraud.
• Electronic Records are the equivalent of paper
records,
• Altering/tampering with an electronic record is
the same as forging a paper record, it’s fraud.
Electronic Records & the law.
21 CFR Part 11 Compliance
19. • Signing a Quality or Production paper record with
someone else’s name is fraud,
• Electronic Signatures are the equivalent of
handwritten signatures,
• Using someone’s else electronic signature to sign
an electronic record required by the FDA is the
same as forging some one else’s signature to sign
a paper record, it’s fraud.
Electronic Records & the Law.
21 CFR Part 11 Compliance
20. • FDA has over 100 years of expertise inspecting paper
records, they can easily detect fraud with paper records,
• They known what they are looking for and can tell at a
glance if a paper record has been tampered with
• It’s harder to detect fraud with an electronic record, it’s
virtually impossible at a cursory inspection.
• Computer Generated Time stamped Audit Trails are used
to give credence and providence to electronic
records/electronic signatures.
• Have to be able to provide a copy of the audit trail
associated with a particular electronic record to an FDA
Inspector either on paper/electronically the Inspectors
request.
Audit Trails
21 CFR Part 11 Compliance
21. • Closed Systems: those systems where a company can
verify the identify of all users before granting access to
an ERES system. Only electronic signatures required,
e.g. username & password combination.
• Open Systems: those systems where a company
cannot verify the identify of all users before granting
access to an ERES system. Digital signatures are
required in addition to electronic signatures, e.g.
digital certificates, HTTPS, etc…
• This is to ensure that the person is who they say they
are.
Open vs. Closed Systems
21 CFR Part 11 Compliance
22. • Onus is on the company using electronic signatures as
the equivalent of hand written signatures to write to
FDA to inform them that the company intends to use
an ERES system.
• Company using an ERES system, must verify and record
the verification of the identify of the user before
granting an signature.
• Train the user’s not to share their esignatures with
anyone else, companies quite often make this a
disciplinary offence.
Procedural requirements
21 CFR Part 11 Compliance
23. • Reading the regulatory wind.
• FDA employ enforcement discretion with the current
Part 11.
• Requirements for record keeping most likely to move
under the applicable predicate rules.
• e.g. Electronic records for Medical Device
Manufacturers would come under 21 CFR Part
820.186 Quality system record instead of 21 CFR Part
11 Subpart B--Electronic Records.
• Requirements for electronic signatures will form new
‘core’ Part 11 version.
Future
21 CFR Part 11 Compliance
24. All Part 11 systems require validation
Regulation
• CFR - Code of Federal Regulations Title 21
Guidance Documents
• Guidance for Industry - Computerized Systems Used in
Clinical Trials
• Guidance for Industry Part 11, Electronic Records;
Electronic Signatures - Scope Application
• General Principles for Software Validation
Validation of Part 11 Systems
21 CFR Part 11 Compliance
26. • Part 11 –
– Exploring the Myths
– Revealing the Facts
– What Does the Future Hold?
• Validation Requirements
• Live Examples
Recap
21 CFR Part 11 Compliance
28. Thank You
21 CFR Part 11 Compliance
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