Document Management & Storage: Pharmaceuticals
Clear and present guidance for full compliance - As well as backing up and storing day-to-day and long-term business information for access and compliance, the pharmaceuticals industry has to abide by specific rules and regulations when it comes to archived data.
EU directive 2005/28/EC and its subsequent inclusion in Statutory Instrument 2006/1928 mean that there are a number of essential areas that must be reviewed, these include:
- compliance of archived data material with current regulations governing storage facilities and ICH/GCP guidelines.
- Archiving the correct documents.
- Clinical documents must be readily available for MHRA inspection.
- Separation of sponsor and investigator data from the same clinical trial.
Tailored Information Management Services for the Pharmaceuticals Sector
We’re dedicated to offering the right storage solutions for our customers as part of our ongoing exceptional service we always guarantee as part of our company values. With this in mind, we are now able to supply a fusion service to assist pharmaceuticals industry customers with reviewing all their archived material.
Working together with Phlexglobal, a specialist contract research organisation, we will carry out an initial assessment on a randomly selected sample of archived material, and give an estimate of any work required to bring storage, tracking and destruction up to industry standard compliance levels. This work could include preparation of archived data such as removing documents from plastic wallets to prevent deterioration; removal of Lever Arch files to reduce volume and, potentially, cost; re-boxing in industry-specified storage boxes with clear labelling and inventory.
Phlexglobal and Restore make a good team and customers can be confident that company SOPs and retention schedules will be checked for files no longer required so that, where appropriate, these will be confidentially destroyed in accordance with BS EN 15713:2009.
Contact us to find out more about our cost-effective, high-security and personalised document management and storage services to the pharmaceuticals sector.