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 theĀ GCP and eRecordsĀ Special Interest Group Forums, and back issues of the Associationās journal.
See the resources available below.
Ā
Useful links
GLP
EMEA Guidance for laboratories that perform analysis or evaluation of clinical trial samplesĀ (so calledĀ āGCLPā)
GMP
EudraLex ā Volume 4: Good manufacturing practice (GMP) Guidelines ā Chapter 4: Documentation
ICH Quality Guideline Q7: GMP Guidance for Active Pharmaceutical Ingredients
(refer to section 6)
GCP
EU Directive 2005/28 (Good Clinical Practice)
Trial Master File Reference Model
Data Integrity
MHRA Guidance on GxP Data Integrity
Electronic records
FDA part 11 guidance for electronic records
International Research on Permanent Authentic Records in Electronic Systems
Model Requirements Specification for the Management of Electronic Records
Other associations
Information and Records Management Society (IRMS)
Information and Records Management Frameworks and Standards (compiled by IRMS)
The Research Quality Association
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 ā Requirements | ISO | Information and Records Management Standards |
| ISO30302 | https://www.iso.org/standard/54673.html | Management systems for records ā 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 |
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 – globally accessible | Ā No | Yes | No |
| Crown Records Management | https://www.crownrms.com/intl/en-gb/page/home | UK | Ā 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 | Ā Yes | Ā No | Ā No |
Publications
Below is a list of publications available from the Health Sciences Records and Archives Association (HSRAA).
This area contains documents relating to the governance of the Health Sciences Records and Archives Association.
The 2ndĀ edition ofĀ the Guide to GCP ArchivingĀ is now available.
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 editionĀ was published in 2014Ā 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 purchaseĀ a printed copyĀ from our onlineĀ publisherĀ for Ā£10.
The HSRAA publication āA Guide to Archiving of Electronic Records (2nd edition)ā 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.Ā 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.
Publications fromĀ the HSRAA GCP special interest group
White Papers published by the Electronic Records Community Forum
This area contains the proceedings of our annual conferences. You can filter to one conference by clicking on the appropriate event.
Members can access resources here: Member Resources
Available for members only, click here if you would like to become a member
Our bi-annual journal provided free to members, containing articles of interest to archivists and records managers.
Members can access resources here: Member Resources
Available for members only, click here if you would like to join
Member Resources
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.