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 by 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
- Admit change needs to happen and then agree on how to go about introducing the change.
- Start by focusing on your QMS documents and procedures, these are the cornerstone of your organisation. Review what you need, and don't be afraid to discard any nolonger 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
Read more about what our customers have to say
"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."
"The new system has improved the GMP compliance and data integrity of our QMS as it comes with audit trails, electronic signatures and automated data analysis tools. It has also made our QMS more efficient."
"We have established a great relationship with Formpipe, and they have listened and understood our requirements, maintain regular contact and any support has been very responsive. The EQMS has exceeded my expectations in terms of efficiency and has allowed Quality Assurance to focus on value-added tasks rather than paper administration."
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 opportunities 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 affect Quality departments.
Read more about our life science offers:
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