This document discusses how SAP can help pharmaceutical companies create a validation environment. It explains that pharmaceutical products must be safe and effective, requiring regulation by bodies like the FDA. Validation ensures processes consistently produce products that meet specifications. SAP follows a V-model for system validation, defining user requirements, functional specifications, and providing reports at each stage including design, installation, operation, and performance qualification to ensure the system performs as expected.
BatchMaster ERP for Pharmaceuticals is a complete, proven and cGMP compliant ERP built specifically for Pharmaceutical, Nutraceuticals, Vaccines, API, Bulk Drugs, Bio-Technology, Ayurveda, Medical Devices and similar industries. Taking care of Distribution, Manufacturing, Compliance, Financial and Quality needs of pharmaceutical & contract manufacturers, it is one complete solution helping around 2000 plus customers stay ahead in the race. Built on the strong foundation of SAP Business One, BatchMaster has been a leader in this domain from last 30 years.
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
BatchMaster ERP for Pharmaceuticals is a complete, proven and cGMP compliant ERP built specifically for Pharmaceutical, Nutraceuticals, Vaccines, API, Bulk Drugs, Bio-Technology, Ayurveda, Medical Devices and similar industries. Taking care of Distribution, Manufacturing, Compliance, Financial and Quality needs of pharmaceutical & contract manufacturers, it is one complete solution helping around 2000 plus customers stay ahead in the race. Built on the strong foundation of SAP Business One, BatchMaster has been a leader in this domain from last 30 years.
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
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.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
computer system is a latest validation system in pharmaceutical industries.
To compliance with the good laboratory practice and good manufacturing practice.
it`s part of 211CFR part 11.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
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.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
computer system is a latest validation system in pharmaceutical industries.
To compliance with the good laboratory practice and good manufacturing practice.
it`s part of 211CFR part 11.
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
Quality, quality concepts
Software Quality Assurance
Software Reviews
Formal Technical Reviews
SQA Group Plan
ISO 9000, 9001
Example
Internal and external attributes
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation.
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1. HOW SAP CAN HELP IN
CREATING VALIDATION
ENVIRONMENT FOR PHARMA
COMPANIES
2. INTRODUCTION
The pharmaceutical business is in charge of all the
improvement, generation and supply of
pharmaceutical items.
These items are required to save lives, avert infection
and aides in keeping up personal satisfaction.
Preparations must be safe and successful for patients
as well as the overall population. Preparation ought
to be such that there is no danger to life or symptom
included. It must protect buyers.
For this, we require administrative bodies who can
control the preparation procedure of these items.
3. REGULATION BODIES
There are International presumed organizations
who goes about as Regulated bodies for
Pharmaceuticals industry:-
Food & Drug Administration (FDA) –Relevant for US
Market mainly
European Medicines Evaluation Agency (EMEA) –
For European Region
Drug Controller General of India –For India
Following are the Regulation involved:
GCP (Good Clinical Practices)
GLP (Good Laboratory Practices)
GDP (Good Distribution Practices)
4. VALIDATION IN PHARMA
COMPANIES
Validation is a procedure of establishing reports which ensures that if
we follow a particular process consistently to produce a product we will
be able to meet predetermined specifications and attributes.
Following are the validations in Pharm Companies:
Process Validation: This includes acceptance of creating Process,
Plant & Machines, and Manufacturing Techniques and so forth.
Cleaning Validation: This includes acceptance of Labs, Production,
Packaging (Proof of clean), Equipment, Machinery, Instruments,
Cleaning Techniques and so forth.
Strategy Validation: This includes approval of Laboratory systems
(R&d… ), Quality Verification techniques, Analytical Equipment and so
forth.
Machine System Validation: This includes approval of Computer
Related Systems (wherever), Computer Systems & Operating systems,
Design, Installation, Performance and so forth.
5. V MODEL FOR SYSTEM VALIDATION
Companies like ArchitectSAP Solutions which are specialized
in providing SAP ECC Support Services follows below model
for establishing necessary SAP environment for pharma
companies:-
6. V MODEL
User Requirement Specifications (URS) : This step characterizes what client needs
from the framework and verifies that necessity is met
Functional Specifications: This step characterizes or makes an archive in client
justifiable arrangement focused around URS. This is produced by functional expert or
merchant or administration supplier.
Design Qualification DQ: This step gives a report which states that the machine
framework prerequisites have been obviously characterized and is sanctioned as URS.
It likewise gives report that states all extra framework particulars are produced,
investigated and approved.
Installation Qualification IQ: In this step record is given which gives the insurance
that all equipment establishment viewpoints are considered as per fitting codes and
sanction outline. Additionally programming establishment is likewise considered.
Operation Qualification OQ: In this step record is given which gives the insurance
that introduced framework functions as tagged.
Performance Qualification PQ: In this step report is given which gives the
assurance that whole framework executes as expected under all operating ranges.
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http://www.architectsap.com/blog/sap-ecc/sap-validation-environment-for-pharma-companies/
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7. V MODEL
User Requirement Specifications (URS) : This step characterizes what client needs
from the framework and verifies that necessity is met
Functional Specifications: This step characterizes or makes an archive in client
justifiable arrangement focused around URS. This is produced by functional expert or
merchant or administration supplier.
Design Qualification DQ: This step gives a report which states that the machine
framework prerequisites have been obviously characterized and is sanctioned as URS.
It likewise gives report that states all extra framework particulars are produced,
investigated and approved.
Installation Qualification IQ: In this step record is given which gives the insurance
that all equipment establishment viewpoints are considered as per fitting codes and
sanction outline. Additionally programming establishment is likewise considered.
Operation Qualification OQ: In this step record is given which gives the insurance
that introduced framework functions as tagged.
Performance Qualification PQ: In this step report is given which gives the
assurance that whole framework executes as expected under all operating ranges.
For More Information, Please visit:-
http://www.architectsap.com/blog/sap-ecc/sap-validation-environment-for-pharma-companies/
Or Follow us on:-
G+ , Facebook or twitter