Operations Management Software Compliance

When discussing the compliance and qualification of management software for GxP operations, there are several aspects to consider. Terms such as 21CFR11, GxPs, and GAMP 5 are referenced in this regard.

Title 21 of the Code of Federal Regulations Part 11 (a.k.a. 21CFR11) is primarily concerned with controls required to be in place for the management of electronic records and electronic signatures. This is particularly important if quality decisions will be based on information documented in your software system and/or approvals are documented in this system.

Title 21 of the Code of Federal Regulations Parts 210 and 211 (a.k.a. cGMPs) have more to do with the general controls required for manufacturing and finishing of drug products.

ISPE GAMP guidelines, and others, focus on best practices consensus regarding the development of sofware and hardware for control systems and other software systems used in the above activities.

Of course, meeting the CFR requirements is necessary for compliance, whereas the GAMP guidelines provide a scalable set of tools to help during the development of compliant systems, using a risk based approach.

It is possible, however, to develop software which meets compliance requirements, but is not efficient for the end user in performing their function. The following are some examples of the types of issues that have come up in our experience.

  • One can design a system with an arduous workflow that is compliant if followed, but may result in the inability of users to consistently follow it correctly. In the end, this can generate more compliance issues than it solves.
  • Software can be developed with a great variety of “bells and whistles”, which provide tempting features, but require so much time to be spent with the software that the workflow is bogged down in minutia. Data entry becomes backlogged, as does compliance.
  • Software can be designed to “do everything” and meet every possible requirement. This can result in software that is forever in configuration mode, until it is finally validated, after which there may be great fear of making changes/upgrades due to the burdensome requalification process. Over time, the system becomes antiquated, with the risk of lost support.

There are myriad other possibilities in which the best intentions of compliance and software design can complicate, rather than simplify, manual operations. This makes it critical to have software developed based on a solid understanding of the operational aspects of the scale of your operation and the applicable regulatory environment. The solution for a 10,000 person company with integrated supply chains may not be the best solution for a company approaching its first pre-approval inspection.

At GxPReady!, we have developed a solution that gives you flexibility, scalability, and simplicity that will help you meet compliance requirements for qualified calibration, maintenance, and/or validation management software, and support a user-friendly workflow. In addition, we have other packages in development and GxP experts that can help you focus on the critical compliance-related issues, without churning out unnecessary complexity in the process. Our folks have experience to separate the features that will help you with compliance from the ones that will just bog down your operations.

You will be surprised how quick and painless the process can be.