B Braun Medical Inc., Going Paperless…
What will be covered
• Background of B Braun Medical Inc.
USA Calibration Program
• FDA Calibration Requirements
• Going Paperless decision and journey
Cover
B Braun Medical Inc., Going Paperless…
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
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B Braun Medical Inc., Going Paperless…
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
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B Braun Medical Inc., Going Paperless…
FDA Calibration Requirements
The two main B Braun calibration requirements by the
FDA can be found in the following Code of Federal
Regulations (CFR’s).
• Part 211, cGMP for finished pharmaceuticals,
Section 211.68 Automatic, mechanical, and
electronic equipment.
• Part 820, cGMP for Medical Devices, Section 820.72
Inspection, measuring, and test equipment.
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B Braun Medical Inc., Going Paperless…
FDA Calibration Requirements
• Part 211, cGMP for finished pharmaceuticals,
Section 211.68 Automatic, mechanical, and
electronic
equipment.
(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.
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B Braun Medical Inc., Going Paperless…
FDA Calibration Requirements
• Part 820, cGMP for Medical Devices, Section 820.72
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.
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(2)Calibration records. The equipment identification, calibration dates, the individual performing each calibration, an
B Braun Medical Inc., Going Paperless…
FDA Calibration Requirements
• Part 820, cGMP for Medical Devices, Section 820.72
Inspection, measuring, and test equipment, cont’d.
(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.
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B Braun Medical Inc., Going Paperless…
FDA Calibration Requirements
• Both CFR’s state if measuring and test equipment is
used to manufacture product:
• Periodically calibrate per written procedures
• Maintain calibration records
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B Braun Medical Inc., Going Paperless…
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
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B Braun Medical Inc., Going Paperless…
Why Go Paperless?
Pro’s and Con’s of a calibration program paperless
system
Pro’s:
• Good for the environment
• Improves efficiency, reduces costs
• Improve compliance (audit trail, data entry
errors, OOT’s, 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
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B Braun Medical Inc., Going Paperless…
Why Go Paperless?
Pro’s and Con’s of a calibration program paperless
system
Con’s:
• Requires power, LAN or WAN
• Software compatibility issues
• Computer security
• Develop/Execute validation protocols
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B Braun Medical Inc., Going Paperless…
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 Braun’s case (total of all 5 sites in RAM)
• #of Assets
36,000
• # of Assets require Calibration 13,750
• # of Calibrations (9/1/12 to 9/1/13)
17,000
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B Braun Medical Inc., Going Paperless…
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.
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B Braun Medical Inc., Going Paperless…
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 (MDT’s)
• 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
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B Braun Medical Inc., Going Paperless…
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.
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B Braun Medical Inc., Going Paperless…
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.)
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B Braun Medical Inc., Going Paperless…
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 emailed to over 400 B Braun personnel
throughout the US and DR.
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B Braun Medical Inc., Going Paperless…
Why Go Paperless?
• B Braun has continued the paperless journey by:
• Utilize Template Data Sheets (validated excel
spreadsheets) to record data and perform
calculations MDT’s can not perform or used
when many parameters are calibrated per one
asset. These data sheets are attached to the Cal
Work.
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B Braun Medical Inc., Going Paperless…
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.
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B Braun Medical Inc., Going Paperless…
Why Go Paperless?
• Process to scanning documents :
• Scanned document in PDF (Portable Document
Format)
• Scan with color on and OCR’ed (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
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B Braun Medical Inc., Going Paperless…
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.
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B Braun Medical Inc., Going Paperless…
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
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B Braun Medical Inc., Going Paperless…
Thank you for your time
Jeffrey Sedor
Metrology/Drafting Manager
B Braun Medical Inc.
2525 McGaw Avenue
Irvine, CA 92614-5895
(949) 660-3085
Fax (949) 660-3295
jeffrey.sedor@bbraun.com
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