Tag

part11
http://www.fda.gov/ohrms/dockets/dockets/04p0429/04p-0429-let0001-vol1.pdf
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Recipient: General Electric Inc.Product: X-ray and fluoroscopic systems Date: 3/31/05 For example, your firm uses electronic database systems to document, track, and control corrective and preventive actions. The Correct Action/Preventive Action System procedure, _____, does not reference the use of these database systems, nor does it describe the steps necessary to close corrective and preventive...
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Company: Sooil Development Co. Ltd.Product:Insulin infusion pump Date: 11/24/04 Failure to document the results of the design validation in the design history file, as required by 21 CFR 820.30(g). For example, the documentation of the bolus and basal infusion testing involving the dispensing software was incomplete. Additionally, as part of your software validation, the report...
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Company: John Sjoding AB Date: 6/29/2004 Product: dental endosseous implants and attachments Failure to have changes in documents reviewed and approved by an individual in the same function or organization that performed the original review and approval, as required by 21 CFR 820.40(b). For example, on October 16, 2003, the K.A. Rasmussen as. Document Number...
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Recipient:Cordis Corporation Product: Sirolimus-Eluting Coronary Stent Date: 4/1/2004 Failure to validate with a high degree of assurance, processes, including changed processes, that cannot be fully verified by subsequent investigation and test, as required by 21 CFR 820.75(a) & (c). For example: The automated [redacted] data acquisition system, used to ensure the integrity of the analytical...
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Company: Michigan Instruments Inc.Product: Thumper Model 1007 Mechanical CPR System Date: 3/23/04 You failed to perform or document the verification or validation of production process changes, such as the Inspiratory Time Test Specification, _____ on 12/17/2002 and the _____ software changes on 11/7/2000 (FDA-483 #11, c. and # 11, i) as required by 21 CFR...
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On 10/23/03, Alan gave a presentation on risk based approaches to Part 11 as recommended in the final FDA guidance.  A copy of the slides are at the link provided. Also available on the site are the slides from Joe Famulare (FDA’s Part 11 lead) presented at this conference. scpred_AKusinitz-Part11AdvamedRiskslides102303
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached document is a reprint of a chapter from an AABB book. The book is titled "Information Technology in Infusion Medicine".  The chapter is on 21 CFR Part 11 Electronic Records;Electronic Signatures and was authored by Alan Kusinitz,...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR has prepared an audit checklist for assessing compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures regulation.  The checklist is intended for use by expert assessors knowledgeable in the regulation, its preamble, history, and current enforcement...
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/docs/MurrayPart11PresentationFoodSafetySummitMarch2003.PDF
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance and Part 11 Representative (John Murray) gave the first presentation on FDA's changes in its approach to Part 11.  The slides from this presentation can be...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The document at the link provided is a SoftwareCPR training aide on Part 11. It provides information and explanation of the Feb 2003 FDA redirection of its Part 11 regulation. It includes a summary of the areas of Part...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. A one page memory jogger for key sections of the Part 11 rule is at the link provided.  This is a SoftwareCPR training and auditing aide. This was updated Feb 2003 to highlight items for which FDA is changing...
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FDA issued a formal federal register notice announcing a new draft guidance for Part 11 titled “Part 11, Electronic Records, Electronic Signatures Scope and Application”. This notice also: officially withdraws not only all earlier draft Part 11 guidance documents but it also withdraws the Part Compliance Policy guide formally announces FDA’s intent to reexamine its...
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Today, FDA issued a new Part 11 guidance draft that reduces the scope and burden of Part 11 significantly.  It essentially suspends enforcement on legacy systems existing prior to the rule’s effective date in 1997 and eliminates: enforcement related to audit trails, electronic copies, and maintenance of electronic records by focusing on meeting the intent...
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ADVAMED and NEMA sent a letter to Dr. Feigal (Director of FDA’s Device Center) raising concerns about Part 11 based on a recent meeting with FDA. They are objecting to the return of Part 11 responsibility to the drug center with no formal device center involvement and the potential that the drug center will issue...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR suggestions for a validation or Part 11 master plan are that it be a high-level plan not providing detailed document or protocol formats. Generally it is best if a master plan is a transient document.  It gets constructed...
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ADVAMED provided a white paper to FDA as part of the Part 11 Industry Coalition. This paper proposes that health and safety risk be used to properly interpret and apply Part 11 and that this approach would resolve some of industry’s issues rather than an approach focused on fraud. ADVAMED BLiebler Part11 Risk Paper
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On Nov 12, 2002 FDA released its 5th draft Part 11 guidance “Electronic Copies of Electronic Records”. The date in the document itself is August 2002. This draft is at the link provided. It addressed content, format, and integrity requirements for provision of records in electronic form to FDA.It: – allows that electronic copies do...
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/docs/FDAPart11DraftArchivingGuidance00d-1539-nad0001.pdf
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http://www.fda.gov/ohrms/dockets/dockets/00d1538/00d1538.htm
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Company: Earlham CollegeDate: 07/29/2002 Product: Prenatal vitamins In addition to the above listed violations, our Investigator noted that the laboratory is using an electronic record system for processing and storage of data from the atomic absorption and HPLC instruments that is not set up to control the security and data integrity in that the system...
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483Company: American Red Cross City and Sate: Baltimore, MD FDA District: Baltimore, MD Dates of Inspection: 4/22-6/21/02 4. Failure of the quality control unit to determine root cause and prevent recurrence of significant deviations related to BSD 73.200M, “Shipping” version 1.7 January 2001. Between October 22, 2001 and April 23, 2002, the Chesapeake Region recorded...
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/docs/NEMAPart11DraftValidationGuidanceComments.pdf
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/docs/SCPRed/SoftwareCPR-Part11GlossaryGuidanceCommentRecord.PDF
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http://www.21cfrpart11.com/pages/sol_prov/solution_providers.htm
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Recipient:Christ Hospital Product: blood bank Date: 9/27/2001 During an inspection of your unlicensed blood bank, conducted on July 26, 30 and August 1, 2001, our investigator documented violations of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act and Title 21, Code of Federal Regulations 211 and 600-680, as follows: Failure to conduct validation...
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Recipient:Dentsply International, Inc Product: dental handpieces and dental accessories Date: 9/26/2001 The inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System regulation...
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WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking. FDA has released it as a draft validation Guidance on Part 11 Electronic Records; Electronic Signatures. These guidance documents were developed by FDA’s Part 11 Compliance Committee. This is a draft, and industry comments will be important in shaping the final guidances. Submit...
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Company: Lee Memorial Health System Date: 8/27/2001 Product: unlicensed blood banks The inspection revealed failure of your blood bank to adequately determine the suitability of persons to serve as whole blood donors. One donor (unit [redacted]) tested repeatedly reactive for HIV 1-2 in screening tests-performed on March 21, 2001 and was never placed in deferral....
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483Company: Schering-Plough Prodcuts, LLC City and State: Las Pierdas, PR FDA District: San Juan, Puerto Rico Dates of Inspection: 5/1-6/5-2001 You have not developed validation/qualification master plans encompassing process, cleaning computer and analytical method validation as directed by the Corporate Quality Assurance Guideline titled Master Plans for Validation/ Qualification issued 10/12/1999. You failed to have...
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The Validation Times Vol III, No. 5 May 2001 reported that James McCormack of FDA : 1. Indicated that the first two FDA Part 11 Guidances may be issued as early as June 2001. These would be the Glossary and Validation guidances. Scope would not be addressed. Other guidances would follow over a period of...
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/Docs/SCPRed/CDRHInfo-collection-reqmtsExcerpts.PDF
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Company: Zeus Scientific Inc.Date: 3/27/01 Product: IVD test kits In addition to the above,your firm failed to validate the electronic documentation system used to record corrective action requests (CARs) prior to implementation. The electronic record requires electronic signature,for which there is no timestamp on the record. Also, you failed to certify to the FDA that...
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Last fall John Taylor, Director, FDA Office of Enforcement took over as leader of the agency’s Part 11 Compliance Committee. As of January 2001: 1. The draft guidances on Validation and Glossary of Terms are now in formal review at the agency. This does not mean they are close to final. 2. FDA has suspended...
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In 2000, a coalition of trade associations was formed to provide input to FDA regarding interpretation of Part 11. This unusual effort across industries has been undertaken due to the global nature of the rule and the cost and impact of compliance to the rule depending on interpretation. The initial group of six national trade...
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The Good Automated Manufacturing Practice (GAMP) organization issued a final draft for review of a guidance for achieving Part 11 compliance for Electronic Records;Electronic Signatures. It is available at the link provided or go to www.gamp.org for more information.. GAMP Part11 draft Note: this is not an FDA Guidance. It was written by an industry...
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Crystal Medical Technology 9/14/00 Dental Implant Devices The inspection revealed deviations from Part 820 including failure to have a manufacturing validation study protocol and to validate software manufacturing equipment and the autoclave sterilization cycle, failure to conduct internal audits, incomplete Device Master Records and Standard Operating Procedures, no Design Plan, no change control procedures and...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 21 CFR Part 11 Electronic Records and Electronic Signatures is a short rule with a lengthy and informative preamble.  The attached training aid provides section of the rule side by side with relevant excerpts of the preamble with some...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached document is a SoftwareCPR training aid with commentary and explanation of 21 CFR Part 11 Electronic Records; Electronic Signatures by SoftwareCPR.  Note the date of this document as this is an evolving area. erecordsesigscommentary09012000-346
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/docs/ASQBiomedicalDivisionPart11comments.PDF
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