Keeping up with certification and compliance in life sciences
Manufacturing is probably the most highly regulated of all the industries and as a result has many bodies watching its every move.
Manufacturers are subject to regular audits to prove they are operating at a subscribed level of competence. These audits are often necessary to prove that a manufacturer can make and sell their products in line with compliance standards and regulatory frameworks. If a company has certifications removed, they might have to stop selling their products, with immediate effect.
And within manufacturing some sub-industries are subject to even more scrutiny than others – Life Sciences is a case in point. Any organization involved in the production of pharmaceuticals must adhere to stringent regulator standards. They have to be able to prove that they are compliant and build historical evidence to support their position. And what’s more, all of this information must be readily available on demand. So production data and documentation need to be unified and accessible, no matter the source, to support analysis, traceability, and reporting. Which is why it’s essential to have a business system that tracks the complete history of product creation, through manufacturing, sales and distribution, whilst maintaining complete end to end traceability.
This is where IFS Cloud can really help. It supports all modes of manufacturing, with industry specific functionality and KPIs embedded as standard. And for Life Sciences this means supporting the full process, from new product development, through production, quality control and delivery with subsequent auditability.
Besides the digital core of financials, human resources, production and distribution, IFS Cloud also includes enterprise asset management (EAM), product lifecycle management (PLM), B2B and customer relationship management (CRM). In addition, IFS project, document, and quality management are substantial capabilities in their own right. IFS Cloud meets the FDA requirement of 21 CFR part 11, where people who complete work or inspections on products must provide a unique and clearly readable signature.
IFS Cloud has integrated Total Quality Management, which offers in-process controls, positive release, and end to end traceability using lot and/or serial numbers. And supporting the Quality functionality is complete, and integrated, document management functionality.
And on top of the regulatory challenges, there’s the constant threat of Cybersecurity attacks, along with pressure to stay agile and up to date with the latest manufacturing thinking. So, how does a highly certified life sciences company keep pace and remain compliant when their manufacturing software is constantly changing? IFS Cloud has been created with monthly updates and feature updates every 6 months. The tool sets provided with IFS Cloud mean it’s possible to compare the certified version, in use by production, with the updated version and identify any changes. This shows which certified processes are affected and may need attention. Only these processes need to be certified and not the whole database, (which is the case in an upgrade). The releases build on each other so it gives customers the choice of when to bring them into production.