Qualification of HVAC Systems As Per WHOAditya Sharma
Qualification of HVAC Systems As Per WHO
Documentation requirements to assist in commissioning, qualification and maintenance
Objectives
Commissioning
Qualification
Design conditions and normal operating ranges set to achievable limits
OOS results recorded
Qualification – examples of aspects to consider
Schedule of tests to demonstrate continuing compliance
Cleanroom monitoring program (1)
Cleanroom monitoring program (2)Particles and Microbiological contaminants
Definition of Conditions
examples of aspects to consider in qualification (OQ, PQ)
Maintenance
Inspecting the air handling system
Qualification of HVAC Systems As Per WHOAditya Sharma
Qualification of HVAC Systems As Per WHO
Documentation requirements to assist in commissioning, qualification and maintenance
Objectives
Commissioning
Qualification
Design conditions and normal operating ranges set to achievable limits
OOS results recorded
Qualification – examples of aspects to consider
Schedule of tests to demonstrate continuing compliance
Cleanroom monitoring program (1)
Cleanroom monitoring program (2)Particles and Microbiological contaminants
Definition of Conditions
examples of aspects to consider in qualification (OQ, PQ)
Maintenance
Inspecting the air handling system
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.
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
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.
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
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.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
An exploration of the topic of Data Integrity including consequences of international regulatory collaboration on the subject, highlights of recent overseas and international guidance documents, as well as common misconceptions.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
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.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
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.
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.
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
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.
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
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.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
An exploration of the topic of Data Integrity including consequences of international regulatory collaboration on the subject, highlights of recent overseas and international guidance documents, as well as common misconceptions.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
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.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
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.
Beamex CMX and GAMP good automated manufacturing practicesChristian Schrøder
This presentation will run you through Beamex CMX calibration software, used in GMP/GAMP environment and how it can help, to get rid of a lot of uncertainties
GMP This white paper is about Electronic Batch Records (EBR) and the role they play in creating a fully digital pharmaceutical manufacturing environment that complies with 21 CFR Part 11.
GxP is a set of regulations and quality guidelines formulated to ensure the safety of life
sciences products while maintaining the quality of processes throughout every stage of
manufacturing, control, storage, and distribution. The GxP standards were established by the
Food and Drug Administration for a range of compliance related activities and are recognized
as:
G: Stands for good
x: Variable
P: Stands for practices
visit : https://www.agaramtech.com/
Calibration, preventative maintenance, Asset Management in Bio-Med Applications. How to comply the FDA validation and Part 11 requirements? computer software for calibration/PM and asset management processes.
To learn about more details, please check out this article.
https://www.qualcy.com/blog/calibration-management-software-asset-management/
Providing SharePoint Solutions in an FDA Regulated EnvironmentDeb Walther
This talk explains to the IT Professional the reasons behind the FDA regulations and what must be considered when implementing SharePoint in a GxP environment.
21 CFR Part 11
- Introduction
- Part 11: Electronic Records & Electronic Signatures :-
Subpart A - General Provisions
Subpart B - Electronic Records Subpart C – Electronic Signatures Good Manufacturing Practices Quality Management Documentation
- Range of requirements for written procedures Standard operating procedures (SOPs)
- Format for standard operating procedures (SOPs) Forms for recording data
- Master formulae
- References
Thank you !!!
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
1. Computerized system validation
Jadhao Pravin H (M.Pharm 1st Year)
Department of Quality Assurance
School of Pharmacy, SRTMU Nanded
Cell No. 9604542553
Email. pjadhao54@gmail.com
2. Computerized system validation
Validation-(as per USFDA)
To established document evidence which provide high
degree of assurance that specified process will be
consistently produced product meeting its predetermined
specification and quality attribute.
Computerized system validation (CSV) is the
documented process of assuring that a computerized
system does exactly what it is designed to do in a
consistent and reproducible manner.
3. CSV Regulations & Guidelines
• US FDA Compliance Policy Guidelines (CPGs)
• Drugs
21 CFR Part 211 (211.68) – Automatic, Mechanical or
Electronic
Equipment (cGMP for Finished Pharmaceuticals)
Guide to Inspection of Computerized Systems in Drug
Processing, Feb 1983
Guide to Inspection of Pharmaceutical Labs (July 1993)
21 CFR 314 (314.70) – Supplements and other changes to an
approved application (Applications for FDAApproval to
Market a new Drug)
Computerized System in Drug Establishments (Feb, 1983)
4. ELECTRONIC RECORDS
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.
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
5. Electronic Records& the law.
• 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.
6. What are ElectronicSignatures
• 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.
7. Audit Trails
• 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’svirtually 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.
8. 21 CFRPart 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.
9. What is Part11
• 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.
10. 21 CFRPart 11 - abrief history
• 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.
11. Scopeof Part 11
• 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…
12. Open vs. Closed Systems
• 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.
13. Good Automated Manufacturing Practice
(GAMP)
• The Good Automated Manufacturing Practice (GAMP)
Forum was founded in 1991 by pharmaceutical industry
professionals in the United Kingdom to address the
industry’s need to improve comprehension and evolving
expectations of regulatory agencies in Europe. The
organization also sought to promote understanding of
how computer systems validation should be conducted in
the pharmaceutical industry.
14. • Computer system validation following GAMP guidelines requires users
and suppliers to work in concert so that responsibilities regarding the
validation process are understood. For users, GAMP provides a
documented assurance that a system is appropriate for the intended use
before it goes “live.” Suppliers can use GAMP to test for avoidable
defects in the supplied system to ensure quality product leaves the
facility.
• If a life sciences company wishes to use GAMP guidelines to set up its
validation systems, some of the elements may already be in place.
Certain aspects, such as the maturity of the hardware or software, must
be taken into consideration to check whether these elements are
“industry proven.” To test the validity of elements in the system, the
appropriate hardware, infrastructure and network must be in place.
When beginning the testing environment, the test author should
understand the testing environment in terms of;
15. • * Correct hardware (peripherals and interfaces);
* Software (validated tools, software configuration);
* Data units (inputs, outputs, quality and quantity of
data);
* Procedures (especially for user acceptance testing);
and
* People (training and experience), (GAMP Good
Practice Guide, pg. 69).