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HSRAA resources

Here you can access HSRAA publications and useful links to documents including Records Management and GxP Archiving Resources.

Members can access the HSRAA and the GCP and eRecords Special Interest Group Forums, and back issues of the Association’s journal.

See the resources available below.

Useful links

Information and Records Management Standards

Below is a list of Information and Records Management Standards for the archiving of paper or electronic data, or samples. This is not a complete listing, and it is recommended that you perform due diligence checks to ensure that you are using the most current and relevant standards and guidances. Please be aware that while the details are correct at the time of publishing, they may be subject to change.

If you have an interest in standards and regulations, why not learn more by coming to our annual conference? Full details here

Standard/Regulation Code Link Description Publisher Standard/Regulation Type
ISO15489 https://committee.iso.org/sites/tc46sc11/home/projects/published/iso-15489-records-management.html Records Management ISO Information and Records Management Standards
ISO16175 https://www.iso.org/standard/55791.html Processes and Functional Requirements for Software for Managing Records ISO Information and Records Management Standards
ISO21965 https://www.iso.org/standard/72312.html Records Management in Enterprise Architecture ISO Information and Records Management Standards
ISO22428 https://www.iso.org/standard/73173.html Managing Records in Cloud Computing Environments ISO Information and Records Management Standards
ISO30301 https://www.iso.org/standard/74292.html Management Systems for Records ‚ÄĒ Requirements ISO Information and Records Management Standards
ISO30302 https://www.iso.org/standard/54673.html Management systems for records ‚ÄĒ Guidelines for implementation ISO Information and Records Management Standards
ISO13008 https://www.iso.org/standard/52326.html Digital records conversion and migration process ISO Information and Records Management Standards
ISO17068 https://www.iso.org/standard/66760.html Trusted third party repository for digital records ISO Information and Records Management Standards
ISO18128 https://www.iso.org/standard/61521.html Risk assessment for records processes and systems ISO Information and Records Management Standards
ISO23081 https://committee.iso.org/sites/tc46sc11/home/projects/published/iso-23081-metadata-for-records.html Metadata for records (in 3 parts) ISO Information and Records Management Standards
ISO26122 https://www.iso.org/standard/43391.html Work process analysis for records ISO Information and Records Management Standards
BS10008 https://shop.bsigroup.com/ProductDetail?pid=000000000030286704 Evidential weight and legal admissibility of electronic information BSI Group Information and Records Management Standards
BS10010 https://shop.bsigroup.com/ProductDetail?pid=000000000030330941 Information classification, marking and handling BSI Group Information and Records Management Standards
NHS RM Code of Practice https://digital.nhs.uk/data-and-information/looking-after-information/data-security-and-information-governance/codes-of-practice-for-handling-information-in-health-and-care/records-management-code-of-practice-for-health-and-social-care-2016 NHS RM Code of Practice
Records Management Code of Practice for HealthRecords Management Code of Practice for Health and Social Care 2016 and Social Care
NHS Digital Healthcare Records Management Standards
n/a https://eur-lex.europa.eu/eli/reg/2016/679/oj General Data Protection Regulation (GDPR) EUR-Lex Data Protection and Privacy Regulations
n/a http://www.legislation.gov.uk/ukpga/2018/12/contents/enacted Data Protection Act (UK) The National Archives Data Protection and Privacy Regulations
n/a http://www.irishstatutebook.ie/eli/2018/act/7/enacted/en/html Data Protection Act (Ireland) Office of the Attorney General, Government of Ireland Data Protection and Privacy Regulations
ISO/IEC 27000 https://shop.bsigroup.com/ProductDetail/?pid=000000000030362045&creative=399709739432&keyword=&matchtype=b&network=g&device=c&gclid=CjwKCAiA0svwBRBhEiwAHqKjFtOSUa2m2Bd25R9A469cb8798Rx-KdIgiPBPzJ4fKT-IWaHLSTPaWhoCtB8QAvD_BwE Information security overview and vocabulary ISO Information Security Standards
ISO/IEC 27001 https://shop.bsigroup.com/ProductDetail?pid=000000000030347472 ISO/IEC 27001
Information security management system requirements
ISO Information Security Standards
ISO/IEC 27002 https://shop.bsigroup.com/ProductDetail?pid=000000000030347481 Code of Practice for Information Security controls ISO Information Security Standards
ISO/IEC 27017 https://www.iso.org/standard/43757.html Information security controls for cloud services ISO Information Security Standards
ISO/IEC 27031 https://www.iso.org/standard/44374.html Information security controls on business continuity ISO Information Security Standards

List of archive vendors

Below is a list of vendors that have been suggested by HSRAA members for the archiving of paper or electronic data, or samples. This list is not an endorsement by the HSRAA of the vendors, and it is recommended that due diligence checks are performed prior to using any vendor. Please be aware that while the details are correct at the time of publishing, they may be subject to change.

If you have an interest in using commercial archive providers, why not learn more by coming to our annual conference or attend our training courses?

Vendor Name Contact details Country/Region Paper archiving? Electronic archiving? Samples?
Ardington Archives LLP http://ardingtonarchives.co.uk / UK Yes Yes No
Arkivum http://arkivum.com/ Virtual Рglobally accessible  No Yes No
Crown Records Management https://www.crownrms.com/intl/en-gb/page/home UK  Yes No No
Cube Records Management http://www.cuberms.com/ UK Yes No No
Deepstore Records Management http://www.deepstore.com/ UK Yes Yes Yes
EPL http://www.eplarchives.com/ France; USA Yes Yes Yes
Grace Records Managment https://www.grace.com.au/information-management/records-management-solutions/ Australia Yes Yes No
Iron Mountain http://www.ironmountain.com/ Global Yes Yes Certain sites only
L&R Storage http://landrstorage.co.uk/ UK Yes No No
MJF Records Management http://mjf.co.uk/ UK Yes No No
Preservica http://preservica.com/ Virtual – globally accessible No Yes No
Qualogy http://www.qualogy.co.uk/ UK Yes No Yes
Restore Document Management http://www.restore.co.uk/ UK Yes No No
Rhenus Logistics http://www.archive-outsourcing.com/en/document-archiving/off-site-records-storage.html Europe  Yes  No  No

Publications

Below is a list of publications available from the Health Sciences Records and Archives Association (HSRAA).

Governance Documents

This area contains documents relating to the governance of the Health Sciences Records and Archives Association.

Good Clinical Practice : A Guide to Archiving

One of the fundamental requirements of the principles of Good Clinical Practice (GCP) is the need to ensure the integrity and secure retention of clinical trial documents for a period of time determined by legal, regulatory and business requirements. Essential Documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements.

The first edition of this guidance was published in 2007. The second edition was published in 2014 to reflect changes in regulations since then, and to address feedback received on the first edition.

The guidance and advice contained within this document are consistent with the requirements of EU Commission Clinical Trial Directive 2001/20/EC and supporting Directives, UK SI 1928:2006, US 21CFR 312 and ICH GCP Guidelines.

This publication can be downloaded for free in PDF format for you to print yourself.

Alternatively you can purchase a printed copy from our online publisher for £10.

A Guide to Archiving of Electronic Records

The HSRAA publication ‚ÄúA Guide to Archiving of Electronic Records (2nd edition)‚ÄĚ is now available.

The retention and archiving of study materials and process records, raw data and source data, is a critical part of compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).

The maintenance and retention of study records is essential to ensure that a study can be reconstructed and the data generated can be verified. Requirements for archiving of electronic records are no different to those for physical records.  However, the variety and complexity of electronic records requires some additional considerations. The purpose of this document is to identify and discuss these features and provide guidance on how best to meet these challenges.

This revised guide has been updated to encompass the many developments that have occurred in the field of electronic archiving since the first edition was published.

Update: We are now making this second edition of our popular Guide to Archiving of Electronic Records freely available to all.
We hope you will find it useful and if you use its content to aid discussions and decision-making within your organisation please reference it as:
Health Sciences Records and Archives Association; A Guide to Archiving of Electronic Records (2nd Edition, November 2020); downloaded from https://the-hsraa.org/resources/publications/guide-archiving-electronic-records/

Click here to download your free PDF copy.

White Papers from the Electronic Records Community Forum

White Papers published by the Electronic Records Community Forum

HSRAA Conference Proceedings

This area contains the proceedings of our annual conferences. You can filter to one conference by clicking on the appropriate event.

Available for members only, click here if you would like to become a member

ONrecord - Current and Back Issues (formerly Sagacity)

Our bi-annual journal provided free to members, containing articles of interest to archivists and records managers.

Available for members only, click here if you would like to join

Member Resources

For member only publications, click here

Available for members only, click here if you would like to become a member

Note for book retailers:
The HSRAA does not maintain a stock of its publications and is unable to fulfil orders received from book retailers. Our publications are available for purchase by the trade from the Ingram Book Company with whom a trade price has been agreed.

Training

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News

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