Why Are Equipment Use Logs Important?
Equipment documentation is fundamental to successful operations. In pharmaceutical and life sciences production, accurate equipment use logs are vital for equipment life-cycle management and compliance.
A thorough equipment maintenance log must effectively manage the use of equipment throughout its life-cycle. Paper and pen have been the traditional means of documenting and logging use. However, such a process is fraught with opportunities for mistakes, omissions, and damage. Digital equipment use-logs not only make both completion and filling simpler and more efficient, but leverages digital functionality to facilitate compliance, improve manufacturing operations, and unlock manufacturing data.
Challenges Of Paper-Based Equipment Use Logs
Paper-based forms have become a basic tick-box exercise. They often rely on human effort for entry and review, which leaves an opportunity for misses. Once they have been archived, managing equipment history becomes a challenge. They become inaccessible and data extraction becomes a time-consuming task.
Equipment use logs are essential to give insights across all assets. Even if completed to perfection, paper-based equipment use logs offer no proactive solutions to managing an equipment’s impact to downstream operations. How do you ensure that what is written down is accurate? What controls are in place to mitigate illegible handwriting or incorrect calculations? While reviews, confirmed by wet signatures, are helpful, risk of human error is not negligible.
In a manufacturing environment, keeping the production line moving is vital. In pharma, and other highly-regulated industries, this need can be complicated by the need for reviews and sign-offs at various stages of the process. Paper-based documents requiring a wet signature rely on the authorized person being onsite and carrying out a manual examination prior to giving their approval. This is necessary from an audit and compliance perspective but can carry operations risks.
Benefits Of Digital Equipment Use Logs
Digital equipment use logs enable effective asset management throughout its lifecycle. OpsTrakker equipment status management software for pharma is designed to ensure right first time execution at every stage of production. Real-time statuses enable greater insight into equipment use and performance. OpsTrakker’s workflows are configurable to verify that equipment meets status requirements. Right first time is crucial in production and OpsTrakker’s equipment status management tools are the best way to meet these goals.
Whether performing activity sign-offs or reviews, there are numerous times in which signatures are essential. But what about the activities that slip through the cracks? Although low, the risk of human error may still have an impact on process performance. OpsTrakker’s computer assisted review, or ‘Review by Exception’ functionality assists in process review. Parameterized equipment leverage attributes which control workflow sequencing. Such attributes may be used to validate entry conditions. When conditions fall outside their validated ranges, a comment is automatically triggered to highlight that review is necessary. Review by exception significantly decreases the time to review processes by highlighting the exact source of the exception. You no longer have to review the entire process, only the items flagged with exceptions. In turn, boosting team productivity and decreasing post-execution review time.
Why Choose Digital Equipment Use Logs?
In a world of increasing regulation, accurate and timely record-keeping is essential for compliance and quality operations. In the pharma and life science industries, right first time production is critical. Digital equipment use logs are automated, pragmatic, and authentic. They don’t make mistakes or get distracted. They deal in facts. They are not designed to make decisions, that responsibility remains with trained professionals. But they are designed to ensure that every detail pertaining to every piece of equipment and every stage of the process is clearly documented and defined.