Ensuring quality is important in every sector, but for pharmaceutical companies, the consequences of improper quality management can be fatal. Compliance with all laws and regulations surrounding quality management and information security is essential in this sector, and that is exactly what the quality departments of these organisations are on top of. One of the standards that is of great importance is Good Laboratory Practices (GLP). We tell you more about it in this blog!
Good Laboratory Practices
Studies on the safety of the use of chemicals for humans, animals and the environment must be carried out according to Good Laboratory Practice (GLP). This is a system to ensure the quality of experiments in laboratories. In the Netherlands, the Healthcare and Youth Inspectorate (IGJ) monitors compliance with GLP standards. This has implications for records management. When pharmaceutical organisations outsource archive management, it is seen as an extension of their own organisation. Archive-IT, for instance, has been audited by several pharmaceutical companies, with successful results. In addition to these audits, Archive-IT has been audited on GLP standards by the IGJ. It can be proudly said that Archive-IT successfully passed this, without any observations.
Security is essential in pharmacy
Within the pharmacy sector, there are a fair number of security requirements that a company must meet. To work with privacy-sensitive documents, such as patient records, examinations, experiments and, for example, instructions for use of medicines, extreme precision is essential. One small mistake can be fatal in this industry. It is therefore also very important to comply with all quality management and information security certifications. The certifications that must be met are:
- ISO 9001 (2015): the standard for quality management of processes.
- ISO 27001 (2013): the standard for information security.
External archiving in line with GLP
Outsourcing critical business information is often a barrier for pharmaceutical companies, precisely because of the strict standards and stringent requirements. Therefore, when it comes to external archiving, it is very important to work with a partner that has information security and quality as its number one priorities. On the other hand, it is the responsibility of pharmaceutical institutions to test the partner for GLP. One runs the risk that the IGJ will inspect the partner and reject it. The GLP archive will then have to be taken away from the partner and housed elsewhere. This not only involves a lot of costs, but also comes at the expense of reliability and increases risks.
In short, if, as a pharmaceutical institution, you make the choice to archive externally, it is imperative that your partner is tested for GLP. In pharma, the security and quality assurance of documents and related processes is essential. Are you interested in the possibilities available with Archive-IT? Then get in touch here with no obligation!
