f there is one place where many business critical documents are stored, it is in the pharmaceutical industry. A well organised archive is crucial and contributes to the primary business process. But what risks do you face when information management is not in order? If we look at industries where audits are an important part of the processes, the pharmaceutical industry is the number one. The Healthcare Inspectorate and other certifying bodies ensure that procedures, evidence, documentation and working methods comply with laws and regulations. Retrieving the right documents at the right time, within the shortest possible time, is therefore very efficient and reduces risks during audits. A digital archive helps with this.
Quality requirements within the pharmaceutical industry
Within the pharmaceutical industry, there are quite a few quality requirements that must be met. The most important guidelines to take into account in the pharmacy are: the Good Manufacturing Practice (GMP), the Good Automated Manufacturing Practice (GAMP) and the Good Laboratory Practice (GLP). Various ISO standards are also important. Think of ISO 17025: general requirements for the competence of testing and calibration laboratories and ISO 9001, for the quality management system. External audits are a logical consequence.
The influence of audits
During these audits, it is essential that information is retrieved in time. Internally, this can be quite a challenge. Information is stored all over the place: digitally, on paper in the relevant departments, in boxes, in the central archive etcera.. There is often no time to find out where a specific piece of archive material is during an audit. Not to mention when the right evidence cannot be found (or not in time).
A digital archive system, even with paper archives
It may sound strange: 'also with paper archives'. In the pharmaceutical industry, a lot of work and archiving is still done on paper. We are noticing a turning point here, but we will be definitely in a hybrid situation with a mix of paper and digital documents for the coming years. This means that an archive system, containing both paper and digital documents, is an investment that will pay for itself in a short space of time. But how does it work? In a digital archive, which is securely accessible via the web, both the physical files/boxes are registered, as well as the digital documents. By using correct metadata, information can be retrieved very quickly
But rooms fill up, information is spread too thin and security cannot be guaranteed in offices or internal archives. That is why organisations choose to place their paper documents in Archive-IT's secure archives. Through the digital archive system the archive documents can be requested 'on demand'. The possibilities are endless. Think of sealed boxes, digital requests, but also (urgent) deliveries of physical archive documents during an audit.
Many more advantages!
It is not only the quick consultation of the right evidence during audits, that is a reason to switch to a digital archive system. Here are some of the benefits you can achieve with (digital) archiving:
- Your archive is up-to-date, so you are always working with the correct version;
- Valuable internal space can be used for other purposes;
- You comply with the correct legislation and regulations and can apply an automated removal policy;
- Your documents are available from any location and can be viewed by multiple users;
- The security of your archive is better guaranteed by extensive logging and authorisation structure.
Do you recognise yourself in the above problem and would you like to discuss the (digital) archiving method within your organisation? Please contact us!
