Compliant eTMF Archiving & Management

Long term eTMF preservation solution

As part of our extended archiving services, Ardington Archives is partnering with Arkivum, an expert in the provision of long term data management and preservation, to provide a secure and compliant hosting service for electronic Trial Master Files (eTMF). The Arkivum solution has been developed to ensure electronic data remains machine readable and accessible for at least 25 years, as per the requirement of EU Regulation 536/2014.

Specifically designed for sponsors and CROs to manage the eTMF and other critical clinical trial documentation, this solution meets the standards of GxP, providing the confidence and protection our regulated customers require. All document access and file movement is recorded to provide a full audit trail, whilst secure access may be granted to regulatory inspections.

As part of a commitment to regulated customers, Arkivum regularly deliver validated (CSV) releases of the software and place a great importance on it’s Quality Management System (QMS) and related SOPs, fully welcoming customer audits.

The eTMF preservation solution includes:

  • Ensuring the data is stored in a cost-effective manner
  • Employing measures to prevent data loss or corruption
  • Preparing for file format changes (and obsolescence) over time
  • Ensuring data is indexed correctly so it can be easily found
  • Providing secure access to the data
  • Capturing a complete audit trail of who has accessed the data and when

Key benefits:

The Arkivum solution ensures that customer data is:

  • Safeguarded: stored in at least three different locations (with full chain of custody) ensuring customer’s data can easily be recovered if any issues occur.
  • Findable: through the use of metadata and advanced search features, quickly and accurately find the right document across multiple and varied datasets.
  • Accessible: ensure that the right people can easily access the right files and importantly, a complete audit trail is captured in each instance.
  • Machine and human readable: avoid file format obsolescence and have the confidence that files created today can be opened, read, and used tomorrow.
We offer unique, customised document scanning and storage solutions.

We work closely with our clients to ensure we deliver a scanning and storage solution to fit their needs. Have a look at some of our other services.

Ardington Archives currently has a total document storage capacity of over 100,000 boxes across three archive stores, together with our in-house argonite pods and secure vaults. Our facilities are modern and purpose-built for storage. In addition, we have the option to expand our secure archive environments to increase total capacity.

At Ardington Archives we understand that fast and efficient document retrieval is vital for the management of any business.  Document retrieval can be requested via phone, email or through our secure online portal service, and if requested by 12 noon, will be returned the next working day, anywhere in the UK.  Requested documents are returned either physically or via electronic format, with both options ensuring a secure and confidential delivery.

At Ardington Archives, we provide a comprehensive range of document scanning and digital conversion services using state-of-the-art equipment. We can advise on the best mix of scanning and hardcopy storage to meet your specific needs.

As part of our document storage service, Ardington Archives works with clients to determine destruction dates for archived documents and files.  Confidential destruction is carried out by twice shredding the documents, before they are pulped and recycled into toilet tissue.  We additionally offer destruction of associated media such as PC hard drives, meeting BSI standards in both Environmental and Information Management.

Ardington Archives has a range of custom designed storage boxes made from high content recycled board.  Designed with a double thickness skin to ensure strength, rigidity and a longer life than most other storage boxes, all Ardington Archives  boxes are PH neutral to maintain the quality and integrity of the documents stored inside, meeting BS 4971 standards.  All boxes are supplied flatpacked for ease of storage and transportation.

In our rapidly-evolving digital era, preserving our cultural and personal heritage has taken a revolutionary turn through heritage scanning. This transformative process involves digitising redords, documents and images, extending their life without causing any damage to the original items.

Get In touch

We would love to hear from you. Please complete the form and we will be in touch shortly. Alternatively, give us a call to discuss your scanning and storage needs.

01367 718710