enKap community

Engaged. Knowledge. Application

Software Supplier Auditing CONTENT Package

Includes a Webinar Recording, Powerpoint Training Presentation, Audit Checklist, frequenty asked questions and answers.

➢ 1.Software Auditing: It's Not Just About Compliance (One Hour Webinar Recording)

➢ 2.Software Auditing: It's Not Just About Compliance (PowerPoint Training Presentation)

➢ 3.Supplier Audit Tool Creation Checklist

➢ 4.Frequently Asked Questions and Answers

Click here to view complimentary excerpt

1.& 2. Software Auditing: It's Not Just About Compliance (One Hour Webinar Recording and PowerPoint Training Presentation)

➢The typical software supplier audit for a FDA-regulated company (what I’ve seen)

➢What I really want to know about my suppliers & why the typical audit is not enough

➢Can just anyone do software audits?

➢Timing is everything

➢Which areas do I audit?

➢An interesting audit tool used by Boston Scientific

➢All that comes before, or preparing for the audit

➢In the room: Questions and answers – some tips: The Players: the prima donna, the talker, the “lawyer,” the obstructionist, the executive, the angry young man

➢The aftermath of the audit: dealing with identified risks

Supplier Audit Tool Creation CHECKLIST

This four-page document can be utilized by industry professionals to help create their own supplier software audit checklist.

Frequently Asked Questions and Answers DOCUMENT

Click here to view complimentary excerpt

Our subject matter expert answers the questions listed below:

➢Isn’t auditing against 21 CFR enough to meet regulatory obligations for software supplier audits?

➢When should software supplier audits be conducted?

➢How long should software supplier audits take?

➢What constitutes objective evidence in a software supplier audit?

➢Who should be in the room during an audit?

➢What happens if a software supplier fails an audit?

Instructor: Eric Henry, former Corporate Software Quality, Boston Scientific

Software Supplier Auditing CONTENT Package is only $99.00





Comment

You need to be a member of enKap community to add comments!

Join enKap community

Contact enKap

Phone: +1-561-308-3093

To e-mail enKap - click here

Members

enKap Terms and Conditions

enKap Terms and Conditions

All sales are final

Legal Disclaimer

This product and any of its enclosures, attachments or appendices, references to online information, conferences or preparations of materials in a variety of formats are created to provide you with accurate and authorative information concerning the subject matter covered. However, this product and any other ancillary items disseminated in connec-
tion with same are not necessarily prepared by a person licensed to practice law in a particular jurisdiction.
enKap, Inc. is not engaged in rendering legal advice, and this product is not a substitute for the advice of an attorney. If you require legal or other expert advice, you should seek
the services of a competent attorney or other professional.
enKap, Inc. necessarily is not, cannot and will not be liable for any claims, damages, or regulatory legal proceedings initiated as a consequence of you, the customer, modifying,
altering, adding to or deleting portions of any product initially provided by enKap, Inc.
Once any original document provided by enKap, Inc. to you, whether in print or electronic format, has been manipulated or customized by you, then the responsibility for the
document’s accuracy, correctness, and compliance are solely yours.
If any action, claim for damages, or regulatory proceedings is commenced against enKap, Inc. as a consequence of your alteration or modification, etc. of the document templates
or other originally provided materials, then and in that event, you agree to indemnify enKap, Inc. for such claims, and for any attorney’s fees expended by enKap, Inc. in connec-
tion with defense of same.

© copyright 2012 enKap

© 2012   Created by enKap.

Badges  |  Report an Issue  |  Terms of Service