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Topic: Computerized system validation


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In the News (Thu 21 Mar 19)

  
 GUIDE TO INSPECTIONS OF
In the past, vendors who submitted their computerized systems to this type of review and were found to be satisfactory, received a letter stating that FDA found the computerized system, as evaluated, to meet the intent of the regulations.
Computerized systems are used not only for the generation of LACF processing records, but for control functions such as: formulation control, process deviation calculations, process temperature, process pressure, process timing and container closure examination.
However; as long as the computerized system controls or records part of or the entirety of a manufacturing process, the manufacturer is responsible for establishing that the computerized system functions as it was intended to function.
www.fda.gov /ora/inspect_ref/igs/foodcomp.html   (9623 words)

  
 Chapter Newsletter   (Site not responding. Last check: 2007-11-02)
Validation of computerized systems used in producing, managing, and reporting data for pharmaceutical activities is required by the US Code of Federal Regulations, Title 21, parts 210 and 211, as well as in other related pharmaceutical areas which will not be included in this article.
The user requirements, system specifications, and validation requirements for all computerized systems must be defined as if the application were to be custom-developed by the end user, and these requirements and specifications should be referenced during the vendor and product audit process.
Computer-related system validation, as defined in the PDA Technical Report No. 18, is "establishing documented evidence which provides a high degree of assurance that a specific computer-related system will consistently operate in accordance with pre-determined specifications." To accurately assess the validation status of a system, the validation requirements must be clearly defined and documented.
www.ispe.org /boston/articles/arch5-0599.htm   (1037 words)

  
 Validating Computerized Systems - Pharm Tech Europe
The area concerning computer systems is described in Annex 11 "Computerized Systems," part of which requires that computer systems are validated from an early stage.
However, it does contain an important statement, which frequently causes problems: "Validation should be considered as part of the complete life cycle of a computer system." Often, the responsible personnel are not aware of this and assume that validation is a single process that takes place at the end of the development phase.
The fact that validation requires extensive documentation must be made clear from the outset, because the quality of a system decreases without this documentation (Figure 4).
www.ptemag.com /pharmtecheurope/article/articleDetail.jsp?id=83306   (906 words)

  
 Definitions
Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may have affected the product's characteristics.
Repeating the validation process or portions of it in order to demonstrate that no changes have occurred which could alter the performance of the original validated equipment or process.
Validation is establishing documented evidence which provides a high degree of assurance that a specific system (an interacting or interdependent group of items that function together to achieve a specific function), process, or facility will consistently produce a product meeting its predetermined specifications and quality attributes.
www.cqionline.com /knowledge/definitions.html   (1184 words)

  
 Computer Validation
Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained.
Validation of the APAP computerized process control system is incomplete in that specific critical finctions have not been tested or validated.
Lack of proper validation protocols and the maintenance of complete and accurate documentation of the performance of the validation protocols and an analysis of the results for the computerized system, Plasma Center Module [21 CFR 606.160 and 21 CFR 211.68(b)].
www.validation-solutions.com /csv1.php   (1103 words)

  
 ISA | Food & Pharmaceuticals Abstracts   (Site not responding. Last check: 2007-11-02)
The validated state of applications supported by the Internetwork may be compromised if the latter is not maintained in a demonstrable qualified state of control.
Within the FDA regulated environment, the process for demonstrating the fitness for intended use of a computerized system, known as computerized system validation, is generally applicable to the highest OSI layer - the application layer.
However, the validated state of a computerized system is directly dependent on the health and fitness of the lower OSI layers, which requires qualification.
www.isa.org /Content/NavigationMenu/Professionals_and_Practitioners/Conferences_and_Exhibitions/ISA_Process_Control_Conference/Food_and_Pharmaceuticals_Abstracts.htm   (4266 words)

  
 Welcome to AAPS   (Site not responding. Last check: 2007-11-02)
Computer system validation is defined as establishment of evidence that a system does what it was designed to do and will continue to do so in the future.
To achieve these objectives, many pharmaceuticals are challenged to find the best way to deliver and document computer validation in a consistent and cost effective manner.
By following the procedures illustrated throughout the course, students will gain the confidence needed to ensure that the validation process will be properly documented at the time of internal and corporate audits as well as meeting the ever challenging regulatory requirements.
www.aaps.ca /csv4004.htm   (383 words)

  
 IMC Validation Consulting   (Site not responding. Last check: 2007-11-02)
Computerized systems are our technical specialty whether it is hardware or software, PC or PLC, old or new, or a proprietary system.
We have validated laboratory equipment from simple (but CPU controlled) conductivity instruments to sophisticated PC-controlled intruments like spectrophotometers and gel scanners.
Our validation group of associates has the the experience in the field to make your process validation successful.
www.prtc.net /~imc001/services-validation.htm   (391 words)

  
 Computerized System Validation Policy   (Site not responding. Last check: 2007-11-02)
All computerized systems develop, deliver and/or maintain by PACIV, Inc. are validatable to meet or exceed the newly revised cGMP’s regulations of the FDA such as current Good Manufacturing Practices (cGMP’s) 21 CFR Sections 68, 210, 211.68, 501, 502, 512, 701, 704 and 820 and Part 11.
All CSV deliverables will be defended from any regulatory agency (internal/external) inspection up to the retirement of the system.
To reach a validated computer system, seven (7) stages must be completed as documented evidence that provides a high degree of assurance that the system is reliable doing what it was designed to do.
www.paciv.com /pages/csv_policy.htm   (227 words)

  
 US Data Management - Services
That the IT based systems are compliant with the current interpretations of the regulations has been and will continue to be a concern of FDA regulated life science companies.
US Data Management LLC provides talented people, intuitive tools and a sound methodology to ensure that systems and operating environments are properly assessed and that people working with and around regulated computerized system understand their respective responsibilities.
Content and Document Management Systems: The USDM team is well versed in the proper implementation and validation of the most respected content and document management systems available today for FDA regulated life science companies.
www.usdatamanagement.com /services.html   (1306 words)

  
 Computerwork.com - Deerfield, Illinois - Sr. Informatics Specialist -- WLV   (Site not responding. Last check: 2007-11-02)
Participate in system upgrade projects to ensure data integrity is maintained.
Must have experience working in regulated environments and computerized system validation; including but not limited CFR 21 Part 11.
Must be able to work with management, regulatory agencies, and customers to provide and configure vigilance systems and data in accordance with current and emerging trends, requests, and developments.
www.computerwork.com /jobsearch/jbdetail_print.cfm?job_id=1333375   (403 words)

  
 Spreadsheet Validation Made Easy (Oct. 5, 2005)
Last year's validation seminar made such a difference that drug and device companies have asked for another chance to train staff who use spreadsheets.
With recent FDA white papers stressing spreadsheet validation and Form 483s and observations zeroing in on spreadsheets, this training is critical for anyone who uses spreadsheets for anything from data collection to QA/QC.
His previous roles in ABB were in the introduction and implementation of 21 CFR Part 11 and computerized system validation projects and initiatives for many key blue-chip pharmaceutical clients.
www.fdanews.com /wbi/conferences/spreadsheet.html   (449 words)

  
 Fog Horn Consultancies - What we do - Content Services
The implementation of system and procedural controls are mandated to reduce human, eliminate vested interests and potential fraudulent situations.
The first requirement of 21 CFR Part 11 is “ Validation of systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records”
To validate computer systems and ensure that they remain in validated state, procedural and technical controls have to be put in place.
www.foghorninc.com /whatwedo_content.htm   (289 words)

  
 Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
The plan typically describes work to be done, resources required, methods to be used, the configuration management and quality assurance procedures to be followed, the schedules to be met, the project organization Project in this context is a generic term.
Best industry practices and FDA Guidance documents indicate that in order to demonstrate that a computer or computerized system performs as it purports and is intended to perform, a methodical plan is needed that details how this may be proven.
The Purpose section should clearly state that the intention of the document is to provide a Standard Operating Procedure to be used to specify the requirements for the preparation of a Project Plan for a new or upgraded software application, computer or computerized system along with the required activities and deliverables.
www.authorhouse.com /BookStore/ItemDetail.aspx?bookid=16607   (1321 words)

  
 [No title]
The system a lab uses to manage its data may be as simple as a paper filing system of hand written forms or as elaborate as a client/server application on top of a relational database management system (RDBMS) and utilizing the latest in wireless network and pen computing technologies.
The computerized LIMS may be as simple as a "single user" system using one desktop computer used to "login" samples and manually enter data in a spreadsheet-like interface with simple text reports of results given to clients.
It is essential for those who work with LIMS as system administrators, managers or end users to have reliable sources of information and expertise in many disciplines including: database programming; (relational) database management system concepts and theories; laboratory processes or operating procedures; statistics and regulatory practices and protocols to mention a few.
lims.taratec.com /lims/lims.199910   (13518 words)

  
 Globeinvestor.com: Ross Systems Announces a Strategic Services Partnership with US Data Management for Computer Systems ...
For these companies, computer system validation is key to ensuring their systems meet overall business objectives and comply with industry regulations.
By embedding the same validation methodology to the installation, testing plans for operation and executing performance testing of the Ross iRenaissance financial systems, companies can streamline their Sarbanes-Oxley compliance initiatives at a far lower cost.
USDM uses proven and recognized methodologies for computerized system validation, helping organizations ensure that the systems they use are monitored, controlled and capable of performing their intended functions in a reliable and reproducible manner.
www.globeinvestor.com /servlet/WireFeedRedirect?cf=GlobeInvestor/config&vg=BigAdVariableGenerator&date=20050614&archive=bwire&slug=20050614005144   (1139 words)

  
 Management   (Site not responding. Last check: 2007-11-02)
Gates is continually assessing new technology (e.g., peer-to-peer systems, Internet II, etc.) for their ability to enhance the delivery and quality of the company's courseware.
Prior to joining Bell Atlantic, he was involved with the conception and development of a personnel management system which was deployed by the US Army.
Handoko has an extensive computer validation and project management experience in the pharmaceutical and biotechnology industry in the last 7 years.
www.learnwright.com /website/managementTeam.htm   (682 words)

  
 Supply & Demand Chain Executive > Research > Archived Articles > Ross, US Data Management Partner on ...
Many of the processes and procedures for computer system validation to meet the predicate rules for CFR 21 are nearly identical for Sarbanes-Oxley financial IT system controls and compliance.
By embedding the same validation methodology to the installation, testing plans for operation and executing performance testing of the Ross iRenaissance financial systems, companies can streamline their Sarbanes-Oxley compliance initiatives at a lower cost, Ross said.
USDM provides services around computerized system validation, helping organizations ensure that the systems they use are monitored, controlled and capable of performing their intended functions in a reliable and reproducible manner.
www.isourceonline.com /article_arch.asp?article_id=7269   (697 words)

  
 Seminars   (Site not responding. Last check: 2007-11-02)
The seminar addresses enabling technologies and mechanisms to ensure that the system remains compliant throughout its lifetime.
The session addresses evaluating the quality of validation deliverables, and is applicable to both internally developed and vendor supplied systems.
It includes a discussion of the issues surrounding computer system validation, and reviews the scope of required validation activities.
www.validassoc.com /serv02.htm   (437 words)

  
 "Labcompliance Info: IVT Computer System Validation Conference. The Most Successful Computer Validation Event Ever "   (Site not responding. Last check: 2007-11-02)
The IVT Annual Computer System Validation conference in Washington was attended by more than 330 people.
GAMP categories two to five as defined in GAMP4 have been expanded into seven categories A to G. This was necessary to address the large variety of lab equipment and systems.
For example, category A is defined as equipment that does not produce raw data, test results or process records but may need calibrations, for example ovens, centrifuges and incubators while category B produces records but they are not stored, for examples, pH-meters and balances.
www.labcompliance.com /info/2004/040405-gamp-lab.htm   (338 words)

  
 Home   (Site not responding. Last check: 2007-11-02)
To offer the most advance, efficient, and complete validation services with knowledgeable and competent personnel to make the client comply with today's FDA / ISO requirements in an effective, easy and rapid manner working within the client needs and capabilities as partners throughout the whole validation process.
We will work with you in equipment and facility design review, computerized system validation, aseptic processing design, calibration programs, environmental monitoring programs, Clean Room certification, GMP audits and sterilization processes.
We can provide your organization with a full range of validation professionals whose backgrounds include engineering, computerized systems, biochemistry and microbiology with extensive industry and technical experience.
www.validationcompliance.com   (291 words)

  
 cGTP Conference Phoenix Arizona - May 2003   (Site not responding. Last check: 2007-11-02)
Systems ranged from a hospital-wide integrated deviation system to a homegrown laboratory-only system, to a multi-site centralized deviation system.
Safa Karandish provided real-life experiences of the trials and tribulations of validating a commercial laboratory software system (StemLab) and developing and validating a system based on a multipurpose database (FoxPro).
Each institution established a validation team and created a master plan including descriptions, specification, requirements, risk analysis, programming and testing, training, maintenance, installation, security, disaster plans, change control and validation plan.
www.celltherapy.org /techtalk/2003/May2003-2.htm   (1010 words)

  
 Kevin Resume'   (Site not responding. Last check: 2007-11-02)
Demonstrated management and technical abilities in the validation of both sterile and non-sterile facilities.
Provided technical guidance for a variety of equipment and computerized systems.
Audited and performed retrospective validation on legacy manufacturing and packaging equipment to comply with FDA regulations.
www.totalserafin.com /Kevin_resume'.htm   (560 words)

  
 Control Engineering - Computerized system validation training   (Site not responding. Last check: 2007-11-02)
If your job (position) is one that holds you responsible for how your company’s or plant’s computerized control systems perform, you should keep reading.
For those seeking ways to put the ideas I presented in the article to work, ISPE and EduNeering are offering a series of online computer system validation training courses to anyone wanting to take them.
The most recent course, ''Requirements for computerized system validation and compliance,'' will be of special interest to those who manage the validation of computer systems in regulated life sciences industries.
www.manufacturing.net /ctl/index.asp?layout=article&articleid=CA317131   (373 words)

  
 EduQuest.net
Which computerized systems FDA has an interest in or regulates – and why,
What FDA expects to see in a validated computerized system.
Auditing the maintenance phase of a validated computerized system.
www.eduquest.net /csv.htm   (279 words)

  
 Nita DuRocher's Resume   (Site not responding. Last check: 2007-11-02)
Over thirty years experience in the computerized control systems.
Responsible for field supervision of all validation personnel.
Presented computerized system CFR 21 Part 11 seminars in various forums.
www.duallcontrols.com /NitaResume.html   (464 words)

  
 US Data Management, LLC   (Site not responding. Last check: 2007-11-02)
US Data Management performs computerized validation services and application development for the biomedical industry.
We were formed especially to implement "quality" orientated information technology based solutions that have both compliancy and efficiency prioritized.
We specialize in computerized system validation, electronic signatures and records, clinical trials management systems, computerized system security issues, and electronic document management systems.
www.basas.com /pages/j_usdatamanage.htm   (171 words)

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