Services> Document and Quality Management Systems

 
Structured documentation means quality and a shorter time to market

 
Implemented correctly, document and quality management systems significantly increase productivity, reduce cost, ensure quality and speed your product to the market.

To achieve this, it is crucial for any Life Science company to search, select and implement solutions that fulfill the business requirements defined by the quality, clinical and regulatory departments, in addition to complying with regulatory requirements, like 21 CFR Part 11.

Accelerate your search and selection process
epista IT’s deep roots in the Life Science industry combined with our solid hands-on experience and advanced knowledge of the IT products specifically designed for Life Science businesses will quickly bring you to the optimal compliance solution that solves your quality, regulatory, IT and business needs.

We offer the tools and methods which accelerate requirements formulation, define clear evaluation criteria and involve your decision-makers from the regulatory, quality and clinical departments.

Implementation – why reinvent the wheel?
epista IT has developed best practices for implementation. These best practices are workshop-driven and are a proven starting point for defining content types and metadata, workflows and security, which are aligned with the requirements from the regulatory, quality and clinical departments. epista IT’s best practices are based on years of experience with implementation of compliance solutions for Life Science companies.