Other examples for today’s problems in the industry are those companies building entire manufacturing facilities (factories, buildings, etc) that end up with a huge amount of paper documentation, but still inefficient for presenting the documentation required in case of a FDA expert control.

Using traditional word processing software to create standard Quality Assurance documents & procedures (like URS, FS, IQ, OQ and PQ) are increasingly becoming inadequate to comply with current regulatory and documentation requirements:

• No guarantee for consistently enforced processes and protocols in all the necessary CFR 21 Part 11 and GxP documentation

• General mistakes, use of incorrect doc. versions, page numbering, references etc.

• Lost documents and missing signatures

• Hard to verify accountability  - ”who did what”

• Significant amount of the total enterprise Quality Assurance time is spent on trivial documentation work, not on improving product or process quality

• Expensive and difficult to prove compliance meaning that there is a de facto risk of non-compliancy during onsite inspections from i.e. the FDA authorities

These well-known industry issues are what the QAtor’s products are developed to solve. With a complete Quality Assurance management solution the throughput speed of your documentation and associated Quality Assurance business will drastically improve and your organization could realize measurable improvements in its Quality Assurance process, also see the introduction to the calculation of your financial benefits when implementing our QA suite of applications.

QAtor’s Risk & Compliance suite is a leader in innovation Web and workflow-based systems that ensure complete control and full compliance with FDA regulations and American and European GMP standards with a simple, cost-effective solution to these complex Quality Assurance challenges.