At DC Allen, Good Documentation Practice (GDP) is employed throughout any development as a matter of course. GDP ensures that our records are complete, accurate and retrievable.
A substantial proportion of product development carried out at DC Allen is in the highly regulated medical sector, in which complete and accurate documentation is required to demonstrate product efficacy.
As well as the creation of a Design History File during the course of a development, we also undertake DHF remediation exercises, in which the original documentation does not meet current regulatory or business requirements. A DHF remediation program will almost always involve significant effort in Verification and Validation – it is typically the case that shortcomings in this area triggered the remediation exercise in the first place.
Software is often an area in which even if the initial documentation was adequate, subsequent documentation is not properly maintained. We embed detailed software documentation within software source code, and use software documentation tools to extract this into complete documentation sets. We have found this to be a highly effective approach, specifically addressing the software documentation maintenance issue.