Webinar IUCLID 6 Questions and Answers

IUCLID 6 Webinar IUCLID 6 Questions and Answers Distributed version: how to prepare for the upgrade in 2016? 13/3/2015

Webinar IUCLID 6 distributed version Q&A Page 1 Table of Contents 1. INTRODUCTION... 2 2. QUESTIONS AND ANSWERS... 3 2.1. Release schedule... 3 2.2. Software requirements... 4 2.2.1. Database... 4 2.2.2. Application server... 5 2.2.3. Operating Systems (OS)... 5 2.3. Hardware requirements... 6 2.4. Installation... 6 2.5. Migration... 7 2.6. IUCLID functions... 9 2.6.1. User management... 9 2.6.2. Backup... 10 2.7. Support, training... 10 2.8. IUCLID integration with other systems... 10

Webinar IUCLID 6 distributed version Q&A Page 2 1. INTRODUCTION The IUCLID 6 webinar took place on 13 March 2015. The objectives of this webinar, dedicated to the IUCLID distributed version users, were: - To inform this category of users about the coming changes (IUCLID 5 compared to IUCLID 6) and the timeline - Give specific guidance on the best way to be prepared and highlight the importance of the IUCLID 6 beta version This document contains the list of Questions and Answers addressed during the second half of the webinar. Question and answer pairs that will require follow-up from the IUCLID team are highlighted in this document.

Webinar IUCLID 6 distributed version Q&A Page 3 2. QUESTIONS AND ANSWERS 2.1. Release schedule Q1: When will it be possible to download IUCLID 6 beta version? A1: As presented in the beginning of this webinar, it is planned for May 2015. Q2: How long will be the time period between the IUCLID 6 final release and REACH-IT 3.x? A2: The current plan is to make IUCLID 6 available one month before the new version of REACH-IT goes live. Q3: Do you think it will be possible to continue to use REACH-IT version 2 and IUCLID 5 in case we are not ready for Q2 2016? A3: Once REACH-IT version 3 goes live in 2016, only the IUCLID 6 format will be accepted. Q4: What about the fact that a lot of companies will already have started before Q2 2016 to generate IUCLID files in version 5 to meet the final deadline in 2018. Why is a completely different program planned to be released just before the 2018 deadline? A4: Data generated with IUCLID 5.6 will be able to be transferred to IUCLID 6 via import or database migration. There are several reasons why IUCLID needs to be updated. The main ones being the need to upgrade technically the application in order to be able to support it in the coming years and the need to follow the latest development of the OECD Harmonised Templates and the evolution of regulatory requirements. This change has been planned to take place two years in advance of the 2018 REACH registration deadline in order to reduce the impact on companies. Q5: When can we start to implement ICULID 6 if the official version is not available? A5: The best way to prepare for the switch from IUCLID 5 to IUCLID 6 is to participate in the IUCLID 6 beta-version testing. IUCLID 6 beta is planned for May 2015. IUCLID 6 official release is planned for Q2 2016. Q6: Is the timeline of migration the same for Biocidal Products Regulation (BPR) dossiers as for REACH dossiers? A6: Yes, REACH-IT and R4BP systems should be updated to work with IUCLID 6 data at the same time in 2016.

Webinar IUCLID 6 distributed version Q&A Page 4 2.2. Software requirements Q7: Can we have a schedule for the official position concerning Software requirements? A7: This will be communicated officially with the release of the IUCLID 6 beta version 2.2.1. Database Q8: So PostgreSQL will not be supported for IUCLID6? A8: This is true; PostgreSQL will not be supported with IUCLID 6. Only JavaDB/Derby and Oracle will be supported. Q9: For the distribution version, will only Oracle be supported? No PostgreSQL anymore? A9: PostgreSQL will not be supported anymore. However, like in IUCLID 5, two different database types will be supported: JavaDB/Derby and Oracle. Q10: Is Oracle freely available? A10: Oracle is not freely available but IUCLID 6 can also be used with a free database version: JavaDB (also named Derby). Q11: It's not really clear for me whether Oracle 12 & Java 8 are required for IUCLID 6 to function or if IUCLID 6 will be able to function without Oracle 12 & Java 8? A11: IUCLID 6 will be able to function with Oracle 12, but another database system, Derby/JavaDB, can also be used. The complete list of supported environments will be communicated at the release time. Java 8 will be required but the beta version of IUCLID 6 will also work with Java 7. Q12: Is it possible to setup IUCLID 6 with Oracle 11g? A12: IUCLID 6 can work with Oracle 11g. However this combination will not be supported for the official IUCLID 6 release in 2016 as Oracle standard support will also be discontinued. Q13: Will the performance for Derby be comparable to PostgreSQL? A13: This is expected and should be confirmed during the performance testing that is currently taking place. Q14: Can PostgreSQL database still be used with GlassFish, IUCLID 6 and Chesar 3? A14: PostgreSQL will not be supported for IUCLID 6. Only JavaDB (Derby) and Oracle will be supported.

Webinar IUCLID 6 distributed version Q&A Page 5 Q15: Any recommendations on using Derby or Oracle from a database size perspective? A15: Recommendations will be communicated in the release notes of the IUCLID 6 beta version but our expectation is that the recommendations for Derby with IUCLID 6 will be similar to those available for PostgreSQL with IUCLID 5. Q16: Will Oracle 10g be compatible though it is not supported by Oracle anymore? A16: This may be the case but will neither be tested nor supported by ECHA. 2.2.2. Application server Q17: So Tomcat will not be supported anymore? A17: This is correct. This is one of the major technical changes between IUCLID 5 and IUCLID 6. The Tomcat application server will be replaced by GlassFish (version 3.1.2 or 4) that will be mandatory. Q18: We have no experience with GlassFish. What does the installation package containing a preconfigured GlassFish look like? Do we only have to extract the package and are good to go? A18: You would have to configure your network as well. 2.2.3. Operating Systems (OS) Q19: Which will be the OS supported by the distributed version (Linux, Windows, Mac OS/X)? A19: All OS are expected to work with the IUCLID 6 version released in Q2 2016. The use of Mac OS with the workstation version still has to be confirmed. The OS tested and supported by ECHA will be made available on the IUCLID website. Q20: What Windows Server is IUCLID 6 compatible with? A20: IUCLID 6 is planned to support Windows Server 2012. Q21: Will there be continued support for Linux servers, in particular CentOS? A21: Yes, this is indeed foreseen. Q22: Will the new IUCLID 6 be running on MacOS? A22: IUCLID 6 is planned to support MacOS but this has not yet been tested for the beta version.

Webinar IUCLID 6 distributed version Q&A Page 6 2.3. Hardware requirements Q23: Recommended hardware sizing for IUCLID 6 in terms of database and operating system? A23: This is currently under definition and recommended hardware sizing will be communicated at the time of the release of IUCLID 6 beta version. Q24: How much memory is required on the relevant host system? A24: This depends on the amount of data and users that are expected in the database. Further information will be provided with the release notes of the IUCLID 6 beta version. 2.4. Installation Q25: Was the server-side tested in virtual environment like VMWare? A25: This is currently tested in this context in ECHA. Q26: It is possible to customize the installation procedure (i.e. changing server name, port number etc.) avoiding to decompress jar files via command-line as in early IUCLID6 test releases? A26: This is currently under investigation and is expected to be available for the IUCLID 6 beta version. Q27: Will it be possible with GlassFish to run two installations of IUCLID 6 on a single (virtual) machine? The databases would be stored on two additional servers. Please advise best practice for multiple installations concerning stability and performance. A27: This has not been tested yet, but we will take your question in consideration for the preparation of the installation instructions. Q28: What are the Pros and Cons of the preconfigured package containing GlassFish for the distributed version? A28: The preconfigured version is expected to be used for standard environments and will be a 'ready to use' package. For more complex environment (e.g. use of proxy, specific port use, etc.), the manual deployment will offer more flexibility. Q29: What about a beta version for the standalone version? A29: A workstation version of IUCLID 6 beta will also be available. It will be provided together with a new installer.

Webinar IUCLID 6 distributed version Q&A Page 7 Q30: If we install IUCLID 6 beta version to test our system, can we still use IUCLID 5.6 to prepare dossier? No problem with testing version 6 while still working and changing the database under version 5.6? A30: Indeed, you should still use the version 5.6 of IUCLID to prepare dossiers for submission to ECHA for example, until the official release of IUCLID 6 in 2016. However you can install and migrate your data to IUCLID 6 to test this new version. The migration from IUCLID 5 to IUCLID 6 copies the data from one system to another so both systems can be used in parallel. Once the official version of IUCLID 6 is available, a final migration from IUCLID 5 to IUCLID 6 will have to be performed. 2.5. Migration Q31: How is the migration process from 5.6 to 6.0? A31: For migration of data a migrator tool will be used. This tool will migrate the data from an existing IUCLID 5.6 database to the new IUCLID 6 database. IUCLID 5.6 files ( i5z extension) will be able to be imported to IUCLID 6. Q32: What needs to be done to prepare IUCLID 5 for migration? A32: In order to migrate a IUCLID 5 database to IUCLID 6, it has to be upgraded to the latest version (5.6). Q33: Is the migration tool a client tool? Can it run on PC or should run on GlassFish server? A33: It is a tool, java application. It does not need glassfish. It needs connection to both databases (i.e. PostgreSQL or Oracle on IUCLID 5 side and Derby or Oracle on the IUCLID 6 side). Q34: During the preliminary testing of the IUCLID 5 to IUCLID 6 migration in 2014 we got a lot of errors. What are experiences of others? A34: The same experience, initially several issues were reported relating to the migration. All known issues have been fixed and the situation has improved. That is why we also encourage users to test the beta version in order to be able to identify and correct any remaining issues before the official release in 2016. Q35: Are there migration problems known or expected going from PostgreSQL to Derby? A35: A migration of the data is a complex procedure therefore it is important to install IUCLID 6 beta, to prepare for the migration and test the procedure. This will help us address possible issues. But not specific issues have been detected for this migration scenario.

Webinar IUCLID 6 distributed version Q&A Page 8 Q36: Will the migration tool be available at the same time as the IUCLID beta version in order to be able to test it in advance? A36: Yes, the migration tool will be available with the beta version to be released in May. It is really important to test the migration with the beta version in order to report any issues to ECHA so that they can be fixed for the official release in 2016. Q37: Which way of migration do you recommend for more than 3,000 substances, via export / import or using the migration tool? A37: The use of the migration tool would be recommended in that case. Q38: We lost all our attachments (pdf, doc, tif etc.) during the update to a previous version of IUCLID 5 - will there be the same risk with the update to IUCLID 6? A38: This issue has indeed affected users who did not have enough disk space available for the migrated data. We are working on the migration report content that currently lists all the data successfully migrated (including e.g. number of datasets, attachments, and dossiers). In addition, after the migration from IUCLID 5 to IUCLID 6, the IUCLID 5 database will remain available so that data can still be transferred afterwards in case a problem is identified. Q39: What happens to the data not migrated from IUCLID 5.4 to 5.6 when IUCLID 6 is already available? A39: One pre-requisite for the migration to IUCLID 6 is to have upgraded the IUCLID 5 database to the latest version (IUCLID 5.6). Manuals are available on the IUCLID website for the description of the IUCLID 5 update procedure. Q40: Will it be possible to import an IUCLID 5.6 i5z to IUCLID 6? A40: Yes, IUCLID 6 will accept the import IUCLID 5.6 files. During import, the data will be automatically migrated to the IUCLID 6 format. IUCLID will not be able to export data in the IUCLID 5 format though. Q41: Will the migration tool support migration of PostgreSQL databases to Derby? A41: Yes. The migration tool will execute the migration. It will connect to both IUCLID 5 and 6 databases and execute the migration from any supported IUCLID 5.6 database to any supported IUCLID 6 database. Q42: Do we need the migration tool for both workstation and distributed versions? A42: The migration tool will be available for both the workstation and the distributed version. But it does not have to be necessarily used as the import of IUCLID 5.6 i5z files will also be possible. The use of the migration tool is recommended for large amount of data (thousands of dossiers) though.

Webinar IUCLID 6 distributed version Q&A Page 9 Q43: Will it be possible to switch the database from a standalone IUCLID 5.6 database to a distributed IUCLID 6 beta version? A43: Yes. If a IUCLID 6 beta version server is deployed and connected to a database, it will be able to use the migration tool to migrate the data from a IUCLID 5 database (used in a workstation or distributed version) to a IUCLID 6 database (used in a workstation or distributed version). 2.6. IUCLID functions Q44: Following scenario: you already have a IUCLID dataset with UUID1 in your database and you want to import another IUCLID dataset that has the same UUID into your database, but you do not want to overwrite the old one, but import it as a new dataset with a new UUID instead. Is this possible? A44: This is not implemented in the IUCLID 6 beta version but will be considered for the future. Q28: In IUCLID 6, will it be possible to create a substance dataset from a dossier? A28: This is not planned to be included in IUCLID 6 but this requirement has already been identified and will have to be prioritized for implementation. Q45: You mentioned new printing functionality in IUCLID 6, can you provide more detail about it? A45: A new print function will be available in the IUCLID 6 beta version. IUCLID 6 documents will be able to be generated in pdf format. However further enhancements are planned to be made until the official release in 2016. Q46: Will the template for the Chemical Safety Report (CSR) under REACH stay the same? A46: The CSR generated from IUCLID 6 will follow the template published on the ECHA website. 2.6.1. User management Q47: What about password policies? Self-service password reset? A47: Password strength will be configurable, as in IUCLID 5, in IUCLID 6 beta version released in May. It is expected that for the IUCLID 6 official version to be released in Q2 2016, password could be reset via mail (if a mail server is configured to be used with IUCLID 6). Q48: Will there be an interface to e.g. LDAP to avoid basic user / password management in IUCLID? A48: Yes, the interface to LDAP, for authentication, is planned to be included in the IUCLID 6 version released in Q2 2016.

Webinar IUCLID 6 distributed version Q&A Page 10 2.6.2. Backup Q49: Were the backup and restore procedures on IUCLID 6 tested? Are they reliable? A49: The backup and restore functions are not yet available in the IUCLID 6 beta version. However they will be based on database backup and restore functions and not anymore implemented in an alternative way like in IUCLID 5. For the distributed version, the administrators of the database should put in place backup procedures. Q50: What about the possibility to schedule backups using a GUI interface, avoiding the traditional command-line? A50: Backup scheduling is not planned to be available in IUCLID 6. This will have to be established, separately by the database manager. 2.7. Support, training Q51: Is ECHA going to prepare webinars on how to manage IUCLID 6 and how to build dossiers? A51: Yes, closer to the official release of IUCLID 6 in 2016, different materials will be made available to support users, such as webinars, video tutorials, updated Help System in IUCLID 6. 2.8. IUCLID integration with other systems Q52: What about web services to link IUCLID data e.g. to office 365 SharePoint sites? A52: Web services are designed for using IUCLID 6 with external systems, but the integration with specific systems will have to be implemented by the users. ECHA will develop the integration of IUCLID 6 for Chesar 3 and the QSAR Toolbox for example and provide guidelines on how to achieve integration with other systems. Q53: Will IUCLID 6 be integrated with IHS Intelligent Authoring via Web Services? A53: Please refer to Q&A 52 above. Q54: Will the new Chesar version be able to read IUCLID 6 files? A54: Yes, Chesar 3 will be integrated with IUCLID 6 and data will be able to be exchanged between the two systems. Q55: Will IUCLID 6 be compatible with previous versions of Chesar or only with Chesar 3? A55: IUCLID 6 will be compatible with Chesar 3 only. Q56: Any IUCLID 6 web service in preparation for interfacing purpose with SAP EHS? A56: Please refer to Q&A 52 above.