Documentation

In the highly regulated world of pharmaceutical and biotechnology production, documentation can easily consume 25 to 50 percent of the resources for any given project. Often, the documentation is a project unto itself. It is also something you cannot do without, as the best system in the world is unusable without proper documentation.

From user requirements to qualification documents and every step between in the GAMP lifecycle, we shoulder the documentation load for clients. We understand for what each document is supposed to be used and what information goes in them. And we understand how managing early documentation steps can make later documentation validation easier to execute.

We define and create any and all documentation required to get your process approved and running, managing the effort through GrandView, our advanced projects management, document library, audit trail and collaboration tool.

Documentation services include:

• Compliance analysis
• Quality and project plans
• Documentation for requirements, design, commissioning, validation and qualification
• User requirements specification
• Process descriptions and operators manuals
• Functional requirements specification
• Programming standards development