In the pharmaceutical industry, it is important to manage archives according to strict requirements. Documentation often needs to remain intact for decades, so that in case of complications, there is always proof of how a medicine was created. To give pharmaceutical organisations a direction on what an archive must comply with, the GLP and GMP have been drawn up. These abbreviations stand for Good Laboratory Practice and Good Manufacturing Practice and encompass the stringent requirements. In addition, pharmaceutical organisations themselves often have criteria that an archive must meet.
Curious about which steps are taken when archiving externally physically?
Selection process
The choice within your organisation has been made. Strict requirements, rising costs, inefficiency or other reasons have made you decide to outsource your archive management. A number of parties are selected that are tested against the strict requirements from the GxP guidelines or legislation and subjected to your own criteria.
At Archive-IT, one of the things we offer is individual storage for your archive that needs to be kept in the most secure way possible. By means of Scanning on Demand, files are available again at lightning speed. For example, during one of the many, strict audits. Our archive hall is heavily secured and equipped with a unique gas extinguishing system. Every file is registered and archived individually, which allows us to guarantee 100% delivery reliability.
During the selection process, Archive-IT is happy to look at the possibilities and specific needs together with your organisation.
Inventory
An inventory is made to decide which archive solution best suits your needs. For example, the scope and complexity of the project is mapped out and, based on this, a quotation is drawn up with a proposal. If this proposal is accepted, cooperation begins and a Service Level Agreement (SLA) is drawn up by mutual agreement. This sets out clear agreements on future cooperation.
Transport
When the archive leaves its own location for the first time, this can be an exciting moment. It is important that nothing goes wrong during transport. This is why Archive-IT offers exclusive transport. At the customer's request, the truck can be sealed. Prior to transport, you receive boxes from us, in which you place the archive. If necessary, these boxes can be sealed with our special seals. Then our secure transport picks up the boxes and transports them directly to the archive hall, where the archive is unloaded in a secure lock.
Registration
Upon arrival, the archive is marked with an Archive-IT barcode and registered in our system. Because the files/boxes are registered and archived individually, we guarantee 100% delivery reliability
No distinction is made between archives that need to be archived in accordance with Good Practice standards and other archives. Archive-IT always applies the strictest security standards for each type of archive.
Archive
The files are stored in our high-security archive building. The archive building is equipped with, among other things, a unique gas extinguishing system, strict access control and camera surveillance. Access control ensures that only authorised people can enter the archive rooms. All activity related to access control is logged in the system.
Archive-IT was recently audited for GLP standards by the Healthcare and Youth Inspectorate (IGJ) with successful results. Archive-IT meets the strict requirements listed in the GLP.
Access
Your archive is always accessible via our certified software Virtual Archive, provided you are authorised to log into the system as a user. Through the software, requests can be made to retrieve records. The requested records are made available digitally via Scanning on Demand or physically delivered to your premises by our own staff.
Digitally, files can be made available within 1.5 hours. Physically, files can be delivered within 24 hours. In some cases, the archive can be delivered to your location faster. This depends on your location and the agreements made in the SLA agreement.
Also, this software is used by you to register new archive material and submit it to us.
Destruction policy
The characteristics necessary to determine whether a box or file is eligible for destruction are recorded in the Virtual Archive. This makes it possible to generate a destruction proposal list, which will then be approved by you. After approval, we will proceed with the destruction of these objects and a certificate of destruction will be sent upon completion. The destruction is carried out by our certified partner PreZezo. PreZero is a specialist in confidential destruction of privacy-sensitive documents.
Audits
At Archive-IT, we know how important an in-house audit is for a pharmaceutical organisation. It goes without saying for us that these can take place regularly. It also gives us room to keep improving and optimising so that we continue to meet the highest quality standards.
Would you like to know what we can do for your organisation? Then contact us here without obligation.
