Source: https://www.softwarecpr.com/category/news/page/77/
Timestamp: 2020-08-14 11:44:22
Document Index: 317681803

Matched Legal Cases: ['art 11', 'art 820', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

News Archives - Page 77 of 85 - SoftwareCPR
Lilly 483 Response
March 8, 2001Amy SellersNews
/Docs/Lilly483Response031801.pdf
Military Software Safety Handbook – 12/31/99
March 4, 2001Alan KusinitzNews
/docs/MilitarySoftwareSafetyHandbookssshdbk.pdf
Nuclear Regulatory Commission Software Reviews
http://www.nrc.gov/NRC/NUREGS/SR0800/CH7/b14v15.htm
Eli Lilly & Company 483
February 23, 2001Amy SellersNews
483Company: Eli Lilly & Company City and Sate: Indianapolis, IN FDA District: Detroit, MI Dates of Inspection: 1/29-2/9, 21, 22, 23/01 18. SOP #001-001757 “Process Control System Security” is used as a global document to describe the guidelines for maintaining the security of the process control systems and related documents for Parentaeral Products Operations. However,...
Ergolight Usability Design and Testing Tool
February 11, 2001Alan KusinitzNews
http://www.ergolight-sw.com/www/Common/company.html
Aventis – LIMS Security
January 22, 2001Amy SellersNews
Company: Aventis Behring L.L.C.Date: 1/22/01 Product: Biological products Product category: Human Drugs Failure to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)] in that changes were not implemented to restrict access and entry...
January 14, 2001Alan KusinitzNews
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...
Extensive Pharmacia Drug LIMS Validation WL
January 11, 2001Amy SellersNews
Company: Pharmacia Corp. Product name: Sterile drug products Product category: Human drugs Date: 1/11/01 The xxxx operation uses both the _____ System and _____ network computer software programs for materials and data management functions. The _____ performs functions typical of a laboratory information management system. The quality control unit uses this program for disposition of...
Pharmacia Drugs Network Software
Company: Pharmacia Corp. Product name: Sterile drug products Product category: Human drugs Date: 1/11/01 The xxxx operation uses both the yyyy System and zzzz network computer software programs for materials and data management functions. The —- performs functions typical of a laboratory information management system. The quality control unit uses this program for disposition of...
FDA Software Standards Recognition 2000
December 28, 2000Alan KusinitzNews
Earlier this month FDA recognized UL 1998 for software. It followed up in the second half of the month by publishing new supplmentary information sheets for all recognized software standards that explains the recognition and how each could be used to reduce software documentation in submissions. Subscribers to SoftwareCPR.com can login, go to the Library...
December 6, 2000Amy SellersNews
Societa Italiana Mediciniali Scandicci 12/6/00 APIs …The computer systems used to control and/or monitor production, reconcile raw materials, assign batch numbers, and control solvents, have not been validated. The validation of the computer system used to control the … process is incomplete…. We have also reviewed your November 3, 2000 written response to the FDA-483…...
SOL Pharmaceuticals – electronic records
November 21, 2000Amy SellersNews
SOL Pharmaceuticals – Active pharmaceutical ingredients – Human Drugs For example, values in at least two … areas were altered. Altered values were written under computer generated values on the … and used in the potency calculations. Review of the electronic data confirmed the incorrect values, which were part of your submission to DMF Your...
Spolana a.s Active Pharmaceutical Software Val
October 30, 2000Amy SellersNews
The _____ systems calibrated by an outside contractor did not include verification of the precision (% RSD) of the autoinjector at more than one injection volume, the flow rate below 1 ml/min, or the wavelength accuracy for the wavelength regions used for testing of _____. In addition, the _____ software programs had not been verified...
compiler val. Sun Nuclear – structural testing
October 12, 2000Amy SellersNews
“Your firm failed to adequately validate software integral to the IVD, IVD wireless and … devices as required by 21 CFR 820.75. For example, structural testing of the software is not completed or documented, there are no software validation protocols available, and the compilers were not validated (FDA 483, Item #5).” SoftwareCPR keywords: Product software,...
September 26, 2000Alan KusinitzNews
/docs/SCPRed/SoftwareCPR-Newsletter092600.PDF
September 14, 2000Amy SellersNews
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...
Oak Rubber – Gloves
Oak Rubber Inc. 9/14/00 Examination gloves A failure to validate the manufacturing process and the computer system used to maintain the product inventory and shipping information. FDA New Orleans District SoftwareCPR Keywords: production software
Paradigm Medical Industries – Part 11
August 30, 2000Amy SellersNews
Failure to maintain accurate, complete, and current records of device accountability [21 CFR 812.140(b)(2)]. There is no documentation of the number of_____ and _____ manufactured and distributed, the number of copies of the controlling software made, or the disposition of each copy of the software. There are no records showing to which sites the device...
Baxter Healthcare Corp. – Part 11
August 11, 2000Amy SellersNews
Company: Baxter Healthcare Corp. Date: 8/11/00 Product: Drug Products Failure to conducted and/or document input/output checks of the _____ computer system. [21CFR211.68] In addition, we further request details regarding steps your firm is taking to bring your electronic cGMP records into conformance with the requirements of 21 CFR Part 11; Electronic Records; Electronic Signatures. Part...
Ophthalmic Instruments Division
July 24, 2000Amy SellersNews
21 CFR 820.184 (d), requires the Device History Record (DHR) to contain or refer to the location of records that demonstrate that the device is manufactured in accordance with the Device Master Record (DMR). Our investigator noted that the wavelength spectrum printout at 200 mWatts (mW) of laser power was not kept nor filed in...
Dermal Tone Inc.
July 12, 2000Amy SellersNews
We are writing to you because we have obtained information that has revealed a serious regulatory problem involving a product known as “Dermal Tone,” which is marketed by your firm. The Dermal Tone is promoted and sold on the Internet at www.dermaltone.corn. See enclosed website material dated 6/29/00. This website material states that “The Dermal...
Integrity Pharmaceutical Corp. – Part 11
July 11, 2000Amy SellersNews
Failure to have appropriate controls over computer or related systems to assure that changes in records are instituted only by authorized personnel, as required by 21 CFR 211.68(b). For example, see FDA-483 observation 12.
AAMI Software Standard Comment Resolutions6/29/00
July 3, 2000Alan KusinitzNews
/Docs/sw68cdv-roc3.PDF
June 24, 2000Alan KusinitzNews
The link above provides the slides and notes of a presentation made by David Manalan reqarding FDA’s Quality System Inspection Technique. David is an associate of SoftwareCPR and you can reach him at DManalan@softwarecpr.com or 978-266-1220. BOSCON manalan QSIT
Poly Implants Protheses Sa – software validation
June 22, 2000Amy SellersNews
Failure to establish and maintain procedures for validating the device design to include validation and to perform design validation under defined operating conditions on initial production units, lots, or batches, or their equivalents; and failure to ensure that devices conform to defined user needs and intended uses and to include testing of production units under...
Obsolete- Oxygen Conserving Device 510(k) Rvw
http://www.fda.gov/cdrh/ode/guidance/583.pdf
Canix Sterilizer – software validation
June 20, 2000Amy SellersNews
Failure to develop, conduct, control and monitor production processes; failure to review the associated data and documentation for finished devices prior to release; failure to validate processes adequately; failure to establish and maintain procedures for implementing corrective and preventive action; failure to validate computer software adequately; and five other violations. Failure to validate computer software...
Sani-Pure Food Laboratories – Part 11
June 14, 2000Amy SellersNews
The computer software your firm uses to determine metals analysis is deficient. It has no security measures to prevent unauthorized access of the software, no audit trails, and data can be copied or changed at will, with no documentation of the copying or changes. Your procedures do not require the documentation of calculation or entry...