Pharmaceutical Document Storage
Restore’s excellent reputation for the provision of Records Management services to the Pharmaceutical sector is borne both from the unique location in which we store records and the additional measures which we have taken to align our provision with the archive requirements of the pharmaceutical sector.
As part of our resolution to regularly review and improve the services we provide, working with Phlexglobal we we are able to offer a complete review of our Pharmaceutical clients archived data, ensuring full compliance with EU directives.
providing you with the right document storage solutions.
Restore are dedicated to offering the right document storage solutions for your specific requirements. With that in mind we are now able to supply a fusion service for those in the Pharmaceutical industry meeting the requirements given in the EU directive 2005/28/EC and its subsequent inclusion in Statutory Instrument 2006/1928.
Working together with Phlexglobal, a specialist contract research organisation we are able to offer a complete review of your archived data to ensure full compliance, including:
- Compliance of archived data material with current regulations governing storage facilities and ICH/GCP guidelines.
- Clinical documents readily available for MHRA inspection.
- Archiving the correct documents.
- Separation of sponsor & investigator data from the same clinical trial
This invaluable service includes full preparation of your archived data, from the removal of plastic wallets to prevent document deterioration along with any lever arch files to reduce volume and potentially the number of boxes stored. If necessary, documentation will be re-boxed in our specified storage boxes with clear labels and an inventory of the box contents. You will be provided with a free of charge report containing an initial assessment of your archived material based on a randomly selected sample. The report will include an estimate of any work required to meet full compliance with the industry standard in terms of storage, tracking and destruction; giving you the confidence that your essential documents are readily available for inspection. Phlexglobal are highly experienced in this field and will follow company SOPs and retention schedules to check for files that are no longer required. Where appropriate, these will be confidentially destroyed in accordance with BS EN 15713:2009.
Our clients can be confident that Restore will deliver the same high level of security and exceptional service that we always guarantee as part of our company values.
Contact us to learn more about our document and archive storage services to the pharmaceutical industry.