6 Life Sciences Software Validation Hurdles and Strategies to Conquer Them

Life sciences companies developing drugs, biologics, or medical devices face many challenges on the road to providing safe and effective products and therapies to market. Validating computerized systems and software and managing the process can be very challenging, time-consuming, and overwhelming for even the most experienced software validation professionals. Software validation is a critical step in the development process to ensure that software applications meet your company’s and the relevant regulatory requirements and function as intended. This post explores some common hurdles in life science software validation we have encountered in our experience that you should be aware of and strategies to overcome them.

1. Customized Software

Try to avoid complex home-grown software solutions. These solutions often lead to much more work than is beneficial for your company. In general, they divert your resources from your core business activities and there are longer-term costs with ongoing maintenance and development expenses along with limited scalability when your organization grows. This approach also may not incorporate life science software validation industry standards or the latest technologies and is often poorly documented, which makes training and updates more difficult. Instead of going it alone, use some of the many affordable commercial off the shelf (COTS) software solutions that have been developed for most of the basic quality, regulatory, and manufacturing functions.

2. Vendor Selection

Do not use vendors that are not familiar with your GxP approach. Vendors who do not work in the life sciences and medical device industry may not understand the regulations, industry standards, and rigor that are needed to ensure data integrity. With unproven vendors, you risk increased regulatory scrutiny and possible violations due to poor documentation practices. Unproven vendors require more oversight from you in life science software validation projects and your processes may be inefficient.

3. Testing

Do not use life sciences software that has not been thoroughly tested prior to being turned over for validation. You risk leaving critical security flaws undetected, which can compromise data integrity. You may also have more bugs and undetected performance and issues, which are more expensive to fix and will cause delays in completing your project on time. Also, be sure to assess (and control as necessary) software upgrades and patches (for bug fixes and updates) rolled out during implementation of your software for impact to other functions in your organization.

4. Business Processes

Remember that transition from paper-based systems to computer systems requires massive changes to business practices and standard operating procedures (SOPs) that may not originally be thought of as “in-scope” of the life sciences computer systems validation project plan. The learning curve, the struggle to adapt to new ways of working, added training for all SOPs, and the transfer of existing paper records to a digital format can be time-consuming and error prone. You should plan to have extra resources available to assist during this transition period.

5. Hybrid Systems

Be sure to understand your plan for dealing with the complications of hybrid systems (partial paper/partial electronic). There will be overlap until all paper systems have been replaced by a holistic digital solution. As with all changes, some people are slower to adopt the new system, so don’t underestimate the resources needed to guide your employees through the process. It is critical to be clear about which activities will continue to be handled via the paper system, which activities will be digitized, and when each activity will be transferred to the new system. In addition, you should have personnel who are outside of the day-to-day work assigned to deal immediately with the complications that arise due to life sciences computer system validation in a hybrid system.

6. System Integration

Validation in pharma and other life sciences environments can be challenging when using multiple systems from different vendors. Be sure to address integration between all systems. Avoid using systems that use incompatible technologies, data formats, or protocols. Be aware that changes to one system may break integration with other systems, which may require ongoing maintenance. In addition, managing data ownership, access rights, and compliance across multiple systems will be challenging.

A well-designed, customized digital validation management system can make this process more efficient, saves time, and lowers cost in the long run. These systems provide a risk-based approach to create a validation plan, transfer operation qualification (TOQ), transfer performance qualification (TPQ), installation qualification (IQ) protocols, and compile the final validation report. Selecting a reputable, well-established digital validation management system and using experienced life sciences and medical device validation professionals to assist in selecting and implementing a digital system that fits your organization’s needs is critical to a successful migration from a paper system to a digitized system.

If you think of how much time and money is wasted throughout your organization writing protocols and reports, chasing paper for revisions, and obtaining approvals, you can see how using a digital validation management system will ease your pain and provide a more compliant, efficient way to manage your company’s drugs, biologics, or medical devices development.