FOI


Implications & Practical Advice from the Blood Establishment Computer Validation Guidance

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When the FDA released the guidance for “Blood Establishment Computer Validation”, you probably logically thought it didn’t apply to you. While the focus of guidance is explicitly blood establishment computer systems, it represents the FDA’s current expectations for validation of high risk computer systems and includes some of the most explicit requirements released by the FDA for computer system validation. If you haven’t studied this document, you’ve missed a missed a thorough and pragmatic case study of FDA’s current expectations for computer validation of high impact computer systems. The guidance includes specific elements that should be included in validation procedures and cites specific methods and testing that should be performed on these systems.

What You Will Learn

  • Specific validation testing cited in the guidance
  • Practices that should be included in your validation procedures
  • System documentation your organization should be maintaining
  • Expected validation deliverable content, including validation plans, risk assessments and validation reports
  • For enterprise level projects, which validation activities can be performed for the entire organization and which activities must be performed at each site
  • Validation activities the FDA expects after system changes

On Wednesday, October 30 at 1:00pm EST, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about this new computer system validation guidance, including a discussion of the testing, system documentation, validation and change control procedures that your organization needs to have implemented to ensure compliance.

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.



Part 11 Compliant Data Management: Doing it Right in the Real World

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FDA requires your investigational drug or medical device data to comply with all of the provisions of 21 CFR Part 11. But how can you generate compliant, reliable data in today’s environment of fewer staff, a disappearing consulting budget and little time for training?

Correctly managing drug or medical device data takes a variety of resources that sponsors, especially smaller firms, rarely have entirely in-house. But business has to run on a realistic budget. How can you balance the necessary requirements with the cost of compliance?

A key tool to minimizing costs and regulatory risks is to find your data management resource gaps…and efficiently fill them.

On Tuesday, April 2 at 1:00pm EDT, join FOI as Russell Barbare, Clinical Operations Manager with Ofni Systems, presents a 90-minute discussion of how to evaluate the skill sets you already have in place for drug or medical device data management – and how you can leverage this knowledge to identify and fill compliance gaps. You’ll hear practical advice on how to implement potential solutions and down-to-earth suggestions for maintaining necessary control in your clinical process.

What You Will Learn

  • The skills you must have available to implement 21 CFR Part 11 and similar regulatory requirements
  • How to maintain control of your compliance
  • The areas most sponsors should probably outsource
  • Practical considerations when dealing with data management budgets
  • How to avoid often-overlooked compliance gaps that could damage your product development

What You Will Get

  • A summary of many of the skills required to produce high quality data
  • Options for data management expenditures
  • Links or references to regulations and resources mentioned in the presentation
  • Practical advice from an instructor who has been involved in drug and medical device data management from preclinical work to final submissions
  • Time for questions and answers

Who Should Attend

  • Clinical data management
  • Regulatory affairs
  • Quality assurance/quality control
  • Clinical software developers
  • Information technology
  • Executives providing input into data management
  • Staff who participate in data management hiring decisions

To Register for this Conference

Click here to register. For more information, or to register over the phone, call FOI Services at 800-654-1147 (+1-301-975-9400 outside the U.S. and Canada).

About Your Instructor

Russell Barbare has spent over decade of experience in clinical trial data management, first as a Data Management Specialist with Gad Consulting Services and subsequently moving to his current position as Clinical Operations Manager with Ofni Systems Inc. This experience has contributed to a large number of successful regulatory filings, covering aspects of development from INDs/IDEs to NDAs/PMAs. Russell has worked on virtually every aspect of clinical data management, including study data collection plans; site and lab auditing; database design and implementation; clinical data software design; regulatory compliance including 21 CFR Part 11 and GxP implementation; data cleaning and extraction; safety, efficacy, and pharmacokinetic analysis; report writing and regulatory submissions. If you would like to know more about the coverage of this presentation, you are invited to contact Russell directly at Russell.Barbare@ofnisystems.com.



Part 11 Isn’t Enough Anymore: Software Compliance for International Markets

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It’s essential to ensure your computer systems are in compliance across your global markets…but where do you start?

As the trend of companies moving to international markets continues, the quality systems used to support GxP operations must move to comply with a wider array of international requirements…and relying on 21 CFR Part 11 to ensure compliance may no longer be enough to meet a country’s validation provisions. When EU Annex 11 was updated last year, it added several new requirements for computer system compliance – and some of these requirements are not addressed in Part 11.

Are you confident you can evaluate your own compliance with international requirements for using electronic records and electronic signatures?

On Monday, March 4 at 1:00pm EST, join FOI Services and Ofni Systems for a 90-minute teleconference for a practical introduction to computer system compliance in international environments. You’ll hear about validation requirements which vary from country to country for manufacturing, clinical and laboratory systems and how they affect password controls, user level security, data security and audit trails, and more…and you’ll increase your understanding of what to look for that isn’t covered by 21 CFR Part 11.

What You’ll Learn

  • How the changes to Annex 11 affect your own GxP compliance
  • Which international regulations apply to your computer systems (and which don’t)
  • The regulations you absolutely can’t overlook
  • Procedures to help you document your compliance
  • The essentials of compliance for electronic records and signatures
  • Requirements to consider before buying computer systems for international GxP use

What You’ll Receive

  • Copies of, or links to, essential documents, including “Annex 11: Computerized Systems” and “EMEA ICH Guideline for Good Clinical Practice”
  • A checklist to determine if your systems are in compliance with international requirements for computer systems
  • A checklist to help identify the gaps in your systems’ international compliance
  • An experienced and approachable instructor
  • Time for questions and answers

Who Should Attend

  • Everyone involved in system validation
  • Anyone selecting computer systems intended for GxP environments
  • Information technology professionals responsible for files or network locations storing GxP data
  • Quality professionals who organize, document and verify system compliance
  • Executives evaluating requirements of prospective markets

To Register for this Conference

Click here to register. For more information, or to register over the phone, call FOI Services at 800-654-1147 (+1-301-975-9400 outside the U.S. and Canada).

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.



Spreadsheet Validation: Ensuring Compliance with 21 CFR Part 11

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Software specifically intended for managing manufacturing processes and FDA submissions may very well be too complex and expensive for your firm’s needs – commonly available spreadsheet programs like Microsoft Excel could be a much better choice. But how can you create, validate and use off-the-shelf spreadsheet programs in your regulated environment without violating the provisions of Part 11?

Easy-to-create and surprisingly powerful and flexible tools for data storage, spreadsheets are so common they may seem almost invisible. But regardless of the program(s) you use, FDA expects the controls to be in place to ensure that GxP processes are validated and compliant with 21 CFR Part 11. FDA will look at your spreadsheets…it’s critical that you are prepared to prove your own Part 11 compliance.

You can confidently harness the versatility, functionality, ease-of-uses and economy spreadsheets offer – and still remain in compliance with FDA’s regulatory requirements.

On Thursday, February 7 at 1:00pm EST, join FOI Services and Ofni Systems for a 90-minute teleconference for specific, practical advice on creating FDA-compliant spreadsheets, spreadsheet validation methodology and maintaining spreadsheets in GxP environments. You’ll even receive first-hand observations describing how FDA manages their own spreadsheets!

What Others Have Said about the Presenter:

  • “This course gave us additional insight into what we could be doing be doing better.”
  • “Super!”
  • “Instructor was very knowledgeable and put the right emphasis on the key points.”

What You’ll Learn:

  • How to design your spreadsheets to facilitate compliance and validation
  • The part of a spreadsheet with the highest regulatory risk – and how to address it
  • How FDA validates its own spreadsheets
  • The expected contents of a spreadsheet validation package
  • How to write spreadsheet requirements and specifications to facilitate good testing
  • What must be included during spreadsheet validation testing
  • The most common deviations discovered during spreadsheet validations, and how to focus your testing to detect these common mistakes

What You’ll Get:

  • Tips to facilitate compliant spreadsheet design
  • A checklist to determine if your spreadsheets are compliant with 21 CFR Part 11
  • Practical examples of requirements, specifications and test scripts
  • Links to a sample spreadsheet validation package, including functional requirements, design specification and executed test scripts.
  • A copy of the white paper “MS Excel Spreadsheet Validation” prepared by Ofni Systems
  • A copy of a FDA Laboratory Information bulletin describing their experience  with spreadsheet compliance software.
  • A trial copy of ExcelSafe, which provides audit trails, password protection, user-level security and electronic signatures to MS Excel spreadsheets
  • An  experienced and approachable instructor
  • Time for questions and answers

Who Will Benefit:

  • Managers and staff responsible for providing valid GxP data for spreadsheets
  • Anyone who designs (or is considering designing) spreadsheets for use in GxP environments
  • Regulatory professionals expected to defend the compliance of spreadsheets
  • Quality professionals who audit company regulatory compliance or are responsible for the procedural requirements required for spreadsheet compliance
  • Information technology professionals responsible for the administration of files or network locations storing spreadsheets incorporating GxP data
  • Computer validation professionals in GxP environments
  • The executives ultimately responsible for developing and maintaining a corporate culture of compliance, including those overseeing regulatory affairs, compliance, operations and strategic planning

To Register for this Conference:

Click here to register. For more information, or to register over the phone, call FOI Services at 800-654-1147 (+1-301-975-9400 outside the U.S. and Canada).

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.



Getting Started with Validation –
What To Validate, When to Validate, How to Prove You Validated It – 11/15/2012

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Getting started with computer validation can seem like an expensive and impossible task. Too often, organizations only perform validations as a reaction to observations, validating systems one by one. Even if this addresses the immediate observation, the next audit reveals yet another system that is out of compliance creating a history of non-compliance. One of the secrets of computer system compliance is that a well-controlled compliance program adds value to your organization. While validation may seem like a cost, an efficient validation program enhances the value your organization by improving quality to your suppliers, reducing business and regulatory risks, and supporting the training and administration required to allow your organization to grow and thrive.

Attendees will learn the following:

  • Which out your computer systems need to be validated… and which do not.
  • The documentation FDA auditors expect to demonstrate your computer systems have been validated and are operating in a compliant manner.
  • The differences between validation, qualification, user acceptance testing, and internal quality, and when each is appropriate.
  • The regulations that your computer systems must comply with, and the procedures that document that compliance.
  • The procedures required to ensure compliance with 21 CFR 11 and Annex 11.
  • What to ask for when purchasing computer systems that will be used in GxP environments.
  • Industry best practices to maximize your validation resources.
  • How to bring System Owners, Users, and Quality together to improve your business..

On Thursday, November 15, 2012 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about desktop database compliance and validation, including specific, practical advice on creating compliant desktop databases, validation methodology, and maintaining desktop databases in GxP environments.

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.



21 CFR Part 11 Compliance and Validation for MS Access Databases – 3/8/2012

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Ofni Systems will address validation and 21 CFR 11 with regard to usage of desktop databases, such as MS Access. Hundreds of 483s and warning letters are received each year by companies who did not design or validate their databases and spreadsheets to meet Part 11 requirements. By properly securing your databases, you can allow a much wider audience to use and benefit from every database within the organization.

The following topics will be covered in detail:

  • Learn what the FDA will look for during audits
  • How to define requirements quickly.
  • How to document inputs, code, and security settings.
  • Details on when and where to use electronic signatures.
  • Inactivity timeouts and controls for users and passwords.
  • Managing change control and common change control mistakes to avoid.

On Tuesday, March 8 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about desktop database compliance and validation, including specific, practical advice on creating compliant desktop databases, validation methodology, and maintaining desktop databases in GxP environments.

Audience Suitability

  • Managers and staff who are responsible for providing valid GxP data for databases
  • Anyone who designs desktop databases for use in GxP environments
  • Regulatory professionals who must defend the compliance of desktop databases
  • Quality professionals who may audit desktop databases or are responsible for administrating procedural requirements required for spreadsheet compliance
  • Information technology professionals responsible for administrating files or network locations storing desktop databases containing GxP data
  • Computer validation professionals working with desktop databases for use in GxP environments
  • Executives who are planning their company’s futures

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.



Designing & Evaluating 21 CFR 11 Compliant Access Databases

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Ofni Systems will address validation and 21 CFR 11 with regard to usage of desktop databases, such as MS Access. Many drug and device firms find that Microsoft Access is a perfect software package for database management with familiar, easy-to-use features, good functionality and smooth integration with other common software. But what should you do to be sure your Access databases are Part 11 compliant? FDA requires evidence of your validation efforts, and regulated industry routinely sees the consequences of non-compliance-–every year, hundreds of 483s and warning letters are issued to companies who did not design or validate their databases to meet these requirements. If you’re using Microsoft Access for your databases, you have very specific Part 11 concerns, and you need to take special care to ensure you have the appropriate audit trails, security, and electronic signature requirements in place.

The following topics will be covered in detail:

  • Learn what the FDA will look for during audits
  • How to define requirements quickly.
  • How to document inputs, code and security settings.
  • Details on when and where to use electronic signatures.
  • Inactivity timeouts, and controls for users and passwords.
  • Managing change control and common change control mistakes to avoid.

On Tuesday, January 10, 2012 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about desktop database compliance and validation, including specific, practical advice on creating compliant desktop databases, validation methodology and maintaining desktop databases in GxP environments.

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.



Spreadsheet Validation: 21 CFR Part 11 Compliance – 2/3/2011

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Software intended for the management of manufacturing processes and FDA submissions may very well be too complex, expensive, and laden with features unnecessary in your environment. Commonly available spreadsheet programs like MS Excel may really be most appropriate – but how can you create, validate and use off-the-shelf programs in GxP environments without violating the provisions of Part 11?

Easy-to-create and surprisingly powerful and flexible tools for data storage, spreadsheets are so common that they can almost seem invisible. However, GxP data stored within spreadsheets must be maintained in accordance with all applicable regulatory rules, especially 21 CFR 11; Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets, but expects controls to be in place to ensure that spreadsheets used in GxP processes are compliant with 21 CFR 11 and are validated. As FDA enforcement of 21 CFR 11 increases, uncontrolled spreadsheets represent an area of increased regulatory concern.

Register for FOI Services’ Spreadsheet Validation: 21 CFR Part 11 Compliance!

You can learn how to harness the versatility and functionality of spreadsheets, giving you and your organization all of the benefits of electronic data systems while remaining compliant with all regulatory requirements.

On Thursday, February 3 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about spreadsheet compliance and validation, including specific, practical advice on creating compliant spreadsheets, spreadsheet validation methodology and maintaining spreadsheets in GxP environments.

What You’ll Learn

  • How FDA validates their own spreadsheets
  • How to design your spreadsheets to facilitate compliance and validation
  • The part of a spreadsheet that has the highest regulatory risk (and how to address it)
  • The expected contents of a spreadsheet validation package
  • How to write spreadsheet requirements and specifications that facilitate good testing
  • What must be included during spreadsheet validation testing
  • The most common deviations discovered during spreadsheet validations (and how to focus testing to detect these common mistakes)

What You’ll Get

  • Tips to facilitate compliant spreadsheet design
  • A checklist to determine if your spreadsheets are compliant with 21 CFR 11
  • Practical examples of requirements, specifications and test scripts
  • Links to a free sample spreadsheet validation package, including functional requirements, design specification and executed test scripts.
  • A free copy of “MS Excel Spreadsheet Validation”
  • A trial copy of ExcelSafe, which provides audit trails, password protection, user-level security and electronic signatures to MS Excel spreadsheets
  • An experienced and approachable instructor
  • Time for questions and answers

Audience Suitability

  • Managers and staff who are responsible for providing valid GxP data for spreadsheets
  • Anyone who designs spreadsheets for use in GxP environments
  • Regulatory professionals who must defend the compliance of spreadsheets
  • Quality professionals who may audit spreadsheets or are responsible for administrating procedural requirements required for spreadsheet compliance
  • Information technology professionals responsible for administrating files or network locations storing spreadsheets containing GxP data
  • Computer validation professionals working with spreadsheets for use in GxP environments
  • Executives who are planning their company’s futures

 

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.



Spreadsheet Validation: 21 CFR Part 11 Compliance – 9/1/2010

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Software intended for the management of manufacturing processes and FDA submissions may very well be too complex, expensive, and laden with features unnecessary in your environment. Commonly available spreadsheet programs like MS Excel may really be most appropriate – but how can you create, validate and use off-the-shelf programs in your regulated environment without violating the provisions of Part 11?

FDA is well aware of the wide utility of spreadsheets, but expects the controls to be in place to ensure that spreadsheets used in GxP processes are validated and compliant with 21 CFR Part 11. In today’s environment of renewed FDA enforcement of Part 11, uncontrolled spreadsheets represent an area of increased regulatory concern and scrutiny.

You can learn to confidently harness the versatility and functionality of spreadsheets. You, your colleagues and your organization can take advantages of all of the benefits of the ease-of-use and economy spreadsheets offer – and still remain in compliance with FDA’s regulatory requirements. Key points that will be covered include:

  • How to design your spreadsheets to facilitate compliance and validation
  • The part of a spreadsheet with the highest regulatory risk – and how to address it
  • How FDA validates their own spreadsheets
  • The expected contents of a spreadsheet validation package
  • How to write spreadsheet requirements and specifications to facilitate good testing
  • What must be included during spreadsheet validation testing
  • The most common deviations discovered during spreadsheet validations, and how to focus your testing to detect these common mistakes

Presented by Ofni Systems, Validation Manager, Ofni Systems
Teleconference, Presented by FOI Services