It's all about compliance!
Regardless of your organisation role within the Life Science industry, compliance is key to being 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.
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.
Our Customers
"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."
"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."
"Platina LS was the natural choice for Probi and, after several demonstrations of competing products, was selected unanimously."
How to go from distress to success!
- We develop software that meets compliance requirements.
- Identifying how we can then use the software to expand business opportunity and increase organisational efficiency.
- Documenting the development, release, and maintenance of the software to ensure we are also compliant.
- Understanding the wider implications of changing the market or regulatory conditions and how they effects Quality departments.
How we co-create
Compliant solutions for the life science industry designed and maintained by life science experts. Helping you Get Compliant and Stay Compliant.
You can read more about our consultancy service for Life Science here.
Don't hesitate to contact us for more information about our products and our consultancy services.
X-docs
Regulatory compliance available out-of-the-box and on a SaaS contract.
Platina LS
Compliance and the ability to be configured to work how you need it to – not only today but also in the future.
Long-Term Archive
Remove the burden of storing records or archived documents within day-to-day systems. Also, retain compliance and the ability to search and retrieve.