Regardless of your organisation role within the Life Science industry, compliance is key to be able to safely and successfully bring new products from research to market while maintaining a healthy profit. However, too often compliance becomes a burden rather than a guiding light of excellence.
Compliance starts with documented procedures detailing the steps that staff follow and proving that your staff understands this. Our eQMS and supplementary products, ensure these steps become easily implemented in your business and the cornerstone of your Quality operation.
Our eQMS products have document management at the heart of them but also offer pre-configured, life science specific workflows, meaning you are not only buying software, but also industry best practice, right out of the box. Robust training-, asset-, and equipment management, all supported my powerful reporting dashboards, means we have your compliance covered, whether it is FDA, EU, MHRA or MPA driven.
CHALLENGES & DRIVES
What drives the industry forward?
Regulatory authorities and customers drive the need for compliance. Markets drive the need but for competitiveness. Under compliance will result in restricted markets and over compliance will hinder competitiveness, so there is a market trend to ensure we are performing at our optimum production level. The move to the cloud is one example of how organisations can now benefit from lower Cost of Ownership, but still maintain compliant systems if they are designed to be delivered via the ease of the cloud.
Challenges within Life Science are:
Admit change needs to happen and then agree how do go about introducing the change.
Start by focussing on your QMS documents and procedures, these are the cornerstone of your organisation. Review what you need, don't be afraid to discard no longer required SOPs.
Select an eQMS product and vendor based on your core requirements, not on all 500 items of your URS. Remember that the team you will work with is just as important as the software.
Ensure you work with people who understand your market.
Berit Lindholm, CEO
"We reviewed many options, but X-docs met our needs best. Formpip's values of professionalism, honesty, transparency and taking a collaborative and consultative approach to projects aligned nicely with our company and thus, made them a great choice as a trusted partner."
Kyle Brinkman, Director QA
"We have been very pleased with Formpipe's X-docs solution, the implementation of X-docs has been a complete success with all objectives being achieved on time and on budget. Their product is and will be a major part of our success and growth."
Emma Årsköld Lind, Product Manager
"Platina LS was the natural choice for Probi and, after several demonstrations of competing products, was selected unanimously."