Software validation is an increasingly important topic for pharma companies. Many regulators, such as the U.S. Food and Drug Administration and the European Medicines Agency, require pharma companies to validate their labeling solutions electronically to maximize patient safety. Complying with these regulations can be a complicated process, especially if a company uses legacy or homegrown systems for labeling and marking.
At the same time, pharma companies are under pressure to streamline operations, reduce costs and increase efficiency to compete better in a challenging market environment. It might seem like a near-impossible task. Achieving and maintaining compliance alone expends time and resources, not to mention simplifying and improving the manufacturing process at the same time.
The good news is it can be done. Many pharma companies have successfully validated their labeling software solutions, even using the validation process as an opportunity to increase operational efficiency. One of the most significant benefits of validation is regulatory compliance. However, validation offers several operational, commercial and business benefits.
Operational benefits
The validation process allows users to familiarize themselves with the labeling solution before it goes live. This means they will be far more comfortable using the system once it’s migrated to production, which ultimately leads to improved operational efficiencies.
Additionally, by validating software at the time of installation, and whenever major updates are introduced to the system, pharma companies can detect software anomalies before they impact their manufacturing operations or cause recalls. Additionally, the extensive testing that companies perform in a non-production environment can greatly reduce the possibility of system failure.
Full traceability – complying with future audits and regulations
The regulatory environment is in constant flux and ensuring patient safety is a top priority. However, meeting new requirements can be a significant burden to businesses. When done right, validation processes ensure that the labeling system works as intended. Companies can be confident the software will provide them with detailed, searchable records making it easier to comply with future audits and regulations.
Realizing these benefits requires pharma companies to take a best-practice approach with their validation projects. Here are five ways that companies can reduce the burden of validating their software solution and what they need to do for successful validation:
1. Be clear on your objectives: When companies validate a labeling solution, they have two primary objectives. First, they want to ensure that all parts of their labeling solution work correctly and consistently. Second, they need to compile documented evidence of this fact.[1] [2] [3] [4] Once objectives are set, it is important to leverage a Validation Accelerator Pack (VAP) — having the right documentation to assist with the validation process has a huge benefit for companies from simplifying compliance to increasing productivity and minimizing costs
2. Understand what the validation process means in a software context: This can be a challenge! It can be helpful to select a labeling solution that is validation-ready, one that is developed with life sciences companies in mind and designed to make the validation process easier.
3. Minimize the number of software updates: Pharma companies need to validate their software each time it’s updated. Some options require updating several times a year, which can be a challenge for IT teams who are pushed into a perpetual cycle of re-validation.
4. Factor in flexibility for testing: Determining the level of testing needed to validate a new labeling solution can be a challenge. Using a three-tier environment, companies can test changes in the DEV environment and validate them in the QA environment, only publishing tested and validated labeling assets to the PROD environment. This allows them to safely test new features/versions while minimizing the need to revalidate the software.
5. Work with a team of experts: companies needing more hands-on assistance with validating their labeling solution – find the right professional advice to support this!
