Those who have been tasked with documentation lifecycle management for highly regulated industries know what a daunting task it can be. Adhering to Good Manufacturing Practices (GMP), such as meticulous management of documentation throughout the product lifecycle, is not just a regulatory requirement but a critical aspect of ensuring product quality and safety. There are several common problems with lifecycle management that can be solved with a purpose-built electronic solution.

High cost of document creation and maintenance

Writing documents by hand is an extremely time-consuming, expensive, and tedious task. Writing and maintaining lifecycle documentation can consume most of a project’s schedule and budget – and still result in inconsistent and error-riddled documents. Traditionally, documents were first created in a word processing environment, then iteratively reconciled with the actual implementation during development and deployment, and finally maintained using time-intensive write/review/edit/approve/revise cycles.

What if you could significantly cut down on those expensive cycles? When a company selects software that can automatically generate documents from imported and archived information, the effort of documentation creation is reduced, while the accuracy of the documentation increases. Companies can achieve a shorter timeline for project documentation with significantly less effort.

Ensuring regulatory compliance

Meeting stringent regulatory standards is a paramount concern for industries governed by GMP. As discussed above, writing documentation by hand can introduce errors that cause problems with regulatory compliance. This could be solved by using documentation software, but if that software is not built to ensure GMP compliance, there is still risk of not fully adhering to compliance standards. By using a software solution designed for compliance, you can feel confident you are audit-ready.

Reliance on third parties

Sometimes instead of writing the documentation themselves, manufacturers will tap a third party to create documentation. Relying on external entities for document creation and management poses challenges related to turnaround time, communication, and potential security risks. Navigating third party documentation creation can be painful, and results aren’t guaranteed.

Instead of searching for an external solution, manufacturers can simplify their documentation efforts by selecting software that eliminates the high time-cost pain point. By internalizing document creation and maintenance, businesses can enhance agility, reduce dependency on external parties, and mitigate the associated risks.

Inadequate change control

It’s important to ensure that documentation is up to date, but this is no simple task. Manual change control processes are prone to oversights, delays, and inconsistencies, jeopardizing the integrity of the documentation. This method of version comparison introduces the possibility of significant human error. Why go through the document refresh fire drill if it isn’t necessary?

Choosing software that can import system and product lifecycle information into a change control database removes the issues introduced by manual review. If documentation is automatically generated from the actual code, discrepancies are eliminated. With automatic document generation software, documentation is always accurate, complete, and up-to-date.

The Bottom Line

It’s clear that documentation lifecycle management is a daunting task. High cost, regulatory requirements, third party outsourcing, and inadequate change control are all obstacles to an efficient process. By selecting software purpose-designed to automatically generate documents and streamline change control for strictly regulated industries, it is possible to eliminate such challenges altogether.

Informetric offers a GMP documentation management tool (AgileDoc®) that has saved companies $575,00-$720,000 and 5,000-6,000 hours on individual projects. If you’re interested in learning more about software for lifecycle documentation management, reach out to Informetric.

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