What will be covered Background of B Braun Medical Inc. USA Calibration Program FDA Calibration Requirements Going Paperless decision and journey B Braun Medical Inc., Going Paperless… Cover

Background of B Braun Medical Inc. Calibration Programs (across 5 sites) Computer program used for tracking purposes only (some sites were not validated therefore audit observations, or not Y2K compliant) All calibrations were recorded on paper data sheets and filed, large number of file cabinets Cumbersome, inefficient, labor intensive Report generation time consuming B Braun Medical Inc., Going Paperless… [1]

Background of B Braun Medical Inc. Calibration Programs (across 5 sites) Data analysis time consuming Human error, data entry errors No audit trail, ensure cal. standards not past due Assign/Review/Approval process slow Ink fades over time Paper lost or damaged B Braun Medical Inc., Going Paperless… [2]

FDA Calibration Requirements The two main B Braun calibration requirements by the FDA can be found in the following Code of Federal Regulations (CFRs). Part 211, cGMP for finished pharmaceuticals, Section Automatic, mechanical, and electronic equipment. Part 820, cGMP for Medical Devices, Section Inspection, measuring, and test equipment. B Braun Medical Inc., Going Paperless… [3]

FDA Calibration Requirements Part 211, cGMP for finished pharmaceuticals, Section Automatic, mechanical, and electronic equipment. B Braun Medical Inc., Going Paperless… [4] (a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.

FDA Calibration Requirements Part 820, cGMP for Medical Devices, Section Inspection, measuring, and test equipment. a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented. B Braun Medical Inc., Going Paperless… [5]

FDA Calibration Requirements Part 820, cGMP for Medical Devices, Section Inspection, measuring, and test equipment, contd. B Braun Medical Inc., Going Paperless… [6] (b)Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision.….. (1)Calibration standards. Calibration standards…traceable to SI… (2)Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.

FDA Calibration Requirements Both CFRs state if measuring and test equipment is used to manufacture product: Periodically calibrate per written procedures Maintain calibration records B Braun Medical Inc., Going Paperless… [7]

Why Go Paperless? To meet FDA calibration requirements, there are two choices: Paper system Paperless system* (*maybe not 100%, but close is good) Both can meet FDA requirements, though the choice is yours B Braun Medical Inc., Going Paperless… [8]

Why Go Paperless? Pros and Cons of a calibration program paperless system Pros: Good for the environment Improves efficiency, reduces costs Improve compliance (audit trail, data entry errors, OOTs, mistake proof, review and signatures) Reduce storage space/cost (files, file cabinets, outside storage facility cost) Quick retrieval of calibration data Automate time consuming task (i.e report generation) Improve data analysis B Braun Medical Inc., Going Paperless… [9]

Why Go Paperless? Pros and Cons of a calibration program paperless system Cons: Requires power, LAN or WAN Software compatibility issues Computer security Develop/Execute validation protocols B Braun Medical Inc., Going Paperless… [10]

Why Go Paperless? If the number of assets that require periodic calibration is small and/or calibrations performed only by calibration vendors, a paper system could meet the FDA calibration requirements. In B Brauns case (total of all 5 sites in RAM) #of Assets 36,000 # of Assets require Calibration13,750 # of Calibrations (9/1/12 to 9/1/13)17,000 B Braun Medical Inc., Going Paperless… [11]

Why Go Paperless? To effectively manage a FDA compliant calibration program over 5 sites with over 36,000 assets, 13,750 requiring periodic calibration, and approximately 17,000 calibrations performed each year, the only feasible solution for B Braun was to implement a Calibration Management System (CMS) software, i.e. BMRAM. B Braun Medical Inc., Going Paperless… [12]

Why Go Paperless? In addition to some of the BMRAM Calibration Management System off the shelf capabilities: Measurement Data Templates (record data) Out of tolerance identification (MDTs) Events Due/Events Past Due (i.e. Recall/Delinquent) Reports Reverse Traceability Report Meets 21 CFR Part 11 Electronic Records; Electronic Signatures Ensure calibration standards are not past due and last calibration in tolerance B Braun Medical Inc., Going Paperless… [13]

Why Go Paperless? B Braun has continued the paperless journey by: B Braun (PA): scanned over 6,730 assets records and attached to respective asset in BMRAM, thus eliminating 10 file cabinets B Braun (PA): scan and attach various forms, vendor calibration reports, and out of tolerance forms. Once scanned, verified, and attached to asset or cal work in BMRAM, paperwork is recycled. B Braun Medical Inc., Going Paperless… [14]

Why Go Paperless? B Braun has continued the paperless journey by: B Braun (CA): scan and attach Lost and Broken forms Once scanned, verified, and attached to asset in BMRAM, paperwork is recycled. B Braun (CA): Scan and attach vendor calibration reports and out of tolerance investigations and notifications for quick access. CA Quality group hesitant to fully utilize scan and attach of GMP data due to previous scanning issues (de-speckle setting which removed dots on each page plus decimal places.) B Braun Medical Inc., Going Paperless… [15]

Why Go Paperless? B Braun has continued the paperless journey by: Created over 90 subscriptions which cover 5 sites each with various business units to run the EventsDueNext30Days and EventsPastDue Reports every Monday morning. These reports are ed to over 400 B Braun personnel throughout the US and DR. B Braun Medical Inc., Going Paperless… [16]

Why Go Paperless? B Braun has continued the paperless journey by: Utilize Template Data Sheets (validated excel spreadsheets) to record data and perform calculations MDTs can not perform or used when many parameters are calibrated per one asset. These data sheets are attached to the Cal Work. B Braun Medical Inc., Going Paperless… [17]

Why Go Paperless? B Braun has continued the paperless journey by: Utilize various BMRAM calibration label reports that print calibration labels via a label printer which reduces cost and improves compliance by having labels that can be clearly read and do not fade, even in bright sunlight. B Braun Medical Inc., Going Paperless… [18]

Why Go Paperless? Process to scanning documents : Scanned document in PDF (Portable Document Format) Scan with color on and OCRed (Optical Character Recognition) Save file in specified location with appropriate filename Verify number of pages and contents of each page Once verified, recycle paper or shred per company policy B Braun Medical Inc., Going Paperless… [19]

Why Go Paperless? B Braun future paperless plans: Scan, verify, attach various documents to active assets and cal work which are currently filed. Recycle paperwork and folders. Scan, verify, and attach various documents to retired assets. Recycle paperwork and folders. Develop process to use Adobe Pro to insert Reviewed by, name, signature, and date on electronic vendor calibration reports versus stamping and hand writing on report, then scan, verify, and attach to cal work. B Braun Medical Inc., Going Paperless… [20]

Conclusion The benefits of a paperless Calibration Management System program far outweigh the cost depending on the number of assets that require periodic calibration and if these calibrations are performed by calibration vendors only or by a combination of calibration technicians and vendors. Improved compliance Improve productivity Reduce cost Reduce human errors Good for the environment B Braun Medical Inc., Going Paperless… [21]

Thank you for your time Jeffrey Sedor Metrology/Drafting Manager B Braun Medical Inc McGaw Avenue Irvine, CA (949) Fax (949) B Braun Medical Inc., Going Paperless… [22]