Conference Posters - 2020

Spreading Quality Culture in a Research Environment through the Involvement of Staff: Two Experiences Developed at the University of Barcelona R.M. Vilanova, S. Mata, M. García, C. Navarro Quality Research Service (QRS), Agency for Quality Assurance, University of Barcelona

Qualification of internal auditors among academics and technical staff 7

years QRS experience

Qualification pathway •ISO 9001 knowledge •Audit skills •ISO 9001 applied to the specific Organization •1-2 audits as observer •1 audit for qualification (supervised by a different senior auditor)

Qualification revision Before annual audit programme: •Auditor qualified if audits performed last two years •Otherwise back to requalification process

13 qualified auditors

Calibration of common use laboratory equipments 25

Training content

Formal evaluation A minimum score of each item should be achieved: •Academic background •Quality training •Experience in quality systems (last 3 years) •Experience in quality audits (last 3 years) •Knowledge of internal processes of the audited organization

50 technicians participants joining UB training plan in 4 years

years QRS experience

•Measurement equipment in a quality system •Basic concepts of equipment calibration •How to calibrate common used equipment: balances, piston pipettes, refrigerators, freezers, oven and incubators •Practical cases: calibration of pipettes and thermohygrometer, characterization of isothermal chambers and use and care of standards (temperature probes, weights, spectrophotometer filters, CO2 analyzer).

Lending QRS certified standards to UB staff for calibration 5 different faculties

Increasing number of standards hires per year

68 active users 7 different faculties/institutes

90 80 70 60 50 40 30 20 10

Continuous feedback 6 workshops of internal auditors since 2014 25 % of internal audits by auditors included in the programme

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These two experiences, calibration of common use equipment and internal audits, give us the opportunity to involve UB staff. We trained and qualified staff of the UB to conduct these activities. The result has been a very satisfactory experience by both QRS and UB staff: 25% of audits performed by non RQS staff and increase of use of standards in last years for equipment calibration and involvement of 7 different faculties and research institutes. This successful partnership allows UB staff to serve as ambassadors of quality culture to research group.

Quality Assurance when introducing New Information Communication Technology JSQA GLP Division, Study Group 3, Subgroup 2 Akira Yamazaki (Kyowa Kirin Co., Ltd.), Hiroe Takeshima (TAIHO PHARMACEUTICAL CO., LTD.), Noriaki Katanosaka (SEKISUI MEDICAL CO., LTD.), Masaki Aota (Astellas Pharma Inc.), Masako Takayama (Mitsubishi Tanabe Pharma Corporation), Norihiro Omae (FUJIFILM Corporation)

IoT (Internet of Things )

Introduction With recent technological innovation, computer systems using new technologies are being developed. For example, the Internet of things (IoT), which provides measurement and control via the Internet, is being introduced into home appliances and analytical equipment, and in addition, Computer Vision that aims to help machines make sense of images is also being developed. However, these new technologies are not yet widely used in GLP facilities in Japan.

Therefore, in order to promote the use of new technologies in GLP facilities in Japan, we examined what new technologies can be used in each process of GLP study.

New ICT systems related to study processes Conduct

Plan

Report Deviation Management

Change Management (Amendment)

Data QC

Result Table

Analysis and Evaluation

Record of Raw Data

Experiment

Material Ordering

(Animal, Reagent etc...)

Preparation of Experiment

RPA

IoT

Expected System

Study Support System

Phase

Material Ordering

A system that can automatically order materials necessary for experiments, such as laboratory animals and reagents.

Chromatographic Experiment to The chromatographic equipment Equipment Analysis and can be monitored and controlled Management Evaluation by the mobile terminal.

System Record of System for digitizing handwritten Raw Data to characters through a camera and Digitizing System Deviation interpreting handwritten records.

Management Pathological Analysis and Evaluation System Evaluation

A system that has completed AI learning on pathological evaluation.

Applications

[e.g.: Handwritten Records Digitizing System] <Principle>

Network Sensing

Scanning

<Example> Handwritten sheet Device Items to be verified on CSV Concept

Project: Verification Operation: Change control

Expected Usage

Compute Handwritten r Vision Records

AI

Sensor

Archive

★Examples of New ICT Systems on GLP ICT

Computer Vision

[e.g.: Chromatographic Equipment Management System]

Points to be checked by QA personnel

• When using a measurement device that can control a mobile device, the mobile device and the measurement device should not be validated separately, but they should be validated as one computerized system.

• Requirements for that system include, but are not limited to: →No access by unauthorized person during control using wireless communications →Data should not be stored in the mobile device. →It is not interfered with by other applications in the mobile device.

• It should be verified that the measurement equipment is controlled by an authorized user and not by an unauthorized user.

• Changes in the model of the mobile device that controls the measurement equipment should be handled in accordance with the change control procedure.

• When installing a new application on that mobile, it should be verified that it is not affected by the change control procedure.

• Control of mobiles for ensuring security • Change control procedures, including process for changing mobile device models or installing new applications • Confirmation of the operation according to the procedure

Conclusions

Ophthalmology Animal No. 101 Timing: Week 4 Finding: No Finding* Corneal Opacity * Description error 01 Apr. 2020 (Signature)

Signal processing

Sensing and Signal processing

OCR Data

Scanning and OCR False recognition or reading error

Ophthalmology Animal No. IOI Timing: Week 4 Finding: He=ξη ・］* * Description error 01 Apr. 2020 ＊＊＊＊

Reorganization True copy (Discard the handwritten sheets)

Electric data Ophthalmology Animal No. 101 Timing: Week 4 Finding: Corneal Opacity ↓ <Audit trail> Due to description error, this finding was changed from No Finding to Corneal Opacity on 01 April 2020 by Akira Yamazaki.

Not recognized as an audit trail

Items to be verified on CSV Concept

• • •

Project:

•

Computer vision is used to convert the content recorded on paper into electronic data to create a true copy.

Corrected records containing a single or double line, will be converted into an audit trail.

After obtaining a true copy, the original paper records are discarded.

After the handwritten records are collected and learned, it is confirmed that the system can recognize letters to the same degree as a person.

If corrected on a single or double line, the original entry is legible and corrected entry is converted into an audit trail.

The types of available scanners should be identified.

Configuration and/or Coding in supplier

•

Project:

It should be verified that the system provides adequate character recognition and audit trail creation when using the company's scanners.

Operation / Retirement

Before the original paper records are discarded, QC checks should be made to ensure that the true copy is equivalent to the paper record. QC checks should be performed in accordance with the risk-based approach. For example, it may be possible to omit checking the handwritten records of preparers for whom authentic copies have been properly obtained in the past.

Verification

Points to be checked by QA personnel

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• •

CSV records during project phase as well as those during operation and retirement phase The risk-based QC checks before the original paper records are discarded

We examined the applicability of the new ICTs to the GLP studies and the expected validation method. It was concluded that even a system using new ICTs would be validated by the conventional method in principle.

However, there are some differences: • For IoT-based systems, it is important to ensure security during wireless communications. In addition, it should be ensured that change control related to mobile devices is appropriate.

• Computer vision-based systems should be checked to ensure that true copies are properly made so that the original paper records can be discarded. This includes verifying that QC checks are properly performed at the time the original paper records are discarded.