Helping you achieve compliant management of all electronic records and documents. Pharmaceutical and life sciences companies operate in a highly regulated environment with long product lifecycles. Their operations are both data and document-intensive. Pharmaceutical product development can take up to 15 years and $1 billion or more per product. Recent demands for increased public accountability against a trend of fewer new products and expiring patents are threatening traditional profitability and revenue growth.
Life sciences departments must share key information with team members and make the best decisions possible based on all relevant information, while complying with government regulations such as the FDA's 21 CFR Part 11 and conforming to industry standards such as GAMP4.
Novaciss Solutions IT Services for the Pharmaceutical and Life Sciences industries support critical processes where compliant management of all paper and electronic records and documents is essential.
We recognize that your processes range from informal research collaborations to formal procedures like SOP review and approval, and that these processes may be limited to single departments, span your enterprise or even include alliance partners, contractors and consultants.
Users can use a range of interfaces ranging from email clients, Web browsers, as well as office and specialty applications, allowing them to work in the environment that is most natural to them.