Services > Quality and Document Management Systems

 

 
Improve quality and time to market through better control of your processes and documentation 

 
Today’s Life Science companies are facing an ever growing jungle of electronic documents, paper documentation and a complex quality related processes. Without proper control these can clog the channels of communication and block the flow of work. When you add an increasing list of regulatory requirements on top of this, you are faced with a problem which can send productivity and quality plummeting!

An electronic document- and quality management system covering both regulated and non-regulated areas can solve this problem. However, the requirements for such a system are not limited to simple management and versioning of documents. To get the full ROI on your investment, a modern Life Science document- and quality system must span your enterprise from pre-clinical, through clinical to quality and production. Thus, the system must accommodate the requirements for full document management and control as well as complex process management. An enterprise document and quality management can support electronic submissions to authorities and quality processes such as changes, deviations and CAPA’s.

By implementing an optimal document and quality management system, the Life Science companies accomplish more control and overview of document and quality related processes, including:

• Document management and control
  • Proper versioning of documents
  • Support of watermarks for controlled documents
  • Workflows to enable collaboration, approval and distribution of documents
  • Comprehensive metadata support for e.g. regulatory documents
  • Support of electronic approvals in compliance with 21 CFR Part 11
• Training Management
  • Support of training activities, including read- and understood of documents
  • Planning of training activities with support of different course types
• CAPA, Changes, Deviations, Complaints
  • Complex workflows, which support these complex processes
  • Notification and reporting functionalities
• Audits
  • Complex workflows supporting internal and external audits
  • Planning of functionalities
  • Handling of issues and findings
• Compliance
• Compliance with 21 CFR Part 11

In the search and selection process for a new document and quality management system, the following must be considered:

Support of many document types – Handling document types with different compliance levels is essential to cover regulatory as well as non-regulatory business areas.

Integration with other systems – Integration to ERP, production systems and especially e-Submission tools is critical.

More internal collaboration – Requires integration with Microsoft Office or other authoring tools to enable change tracking, checking in and out, etc.

External collaboration – Since development is often done with partners, external collaboration support is also a must.

A real solution for Life Science requires:
- Deep knowledge of these business requirements;
- Clear understanding of the related compliance requirements unique to Life Science; and
- Experience with the technology that supports these challenges.

epista IT can help. We’ll give you a head start on successful Document and Quality Management systems.