New CISPro Biological Materials Module Delivers Unique Functionality for Tracking Biological Material in Inventory

ChemSW has released a new version of their CISPro Biological Materials Module that delivers enhanced functionality for tracking biological materials in inventory. Biological materials are traditionally difficult to track because they vary greatly in size, storage, and information needs, and they are easily propagated. As a result, traditional chemical inventory approaches don't apply well to biological materials. With CISPro's Biological Materials Module, it is now possible to easily track different biological criteria in inventory by user-defined properties as well as by sample or stock location.

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Accurate Information Drives More Effective Operations

Off-the-shelf Chemical Inventory Systems (CIS) can deliver a high-performance, relational database system for tracking chemicals and other laboratory supplies. Accurate, real-time inventory information enables all types of pilot plants - from API and hydrogenation pilot plants to biopharmaceutical and dosage form pilot plants - to operate more effectively, regardless of whether the facilities are regulated or non-regulated or whether Good Manufacturing Practices (GMP) are utilized.

Chemical Inventory Challenges

There are numerous challenges associated with ensuring that a CIS is accurate and supports validation. For instance, because each batch has unique processing and ingredient requirements, the CIS must reflect inventory accurately and support operations so that a continuous flow of material is available when and where needed. The CIS must also provide accurate and complete documentation for each production run.

For pharmaceutical pilot plants, not only is regulatory compliance mandatory with severe consequences for non-compliance (Figure 1), but requirements often change. A legacy or in-house system that may have met the requirements in the past might now be using awkward, inefficient workarounds to address modifications or changes to U.S. FDA rules


Figure 1. An accurate, quality-oriented CIS can help avoid many of the numerous potential costs and consequences associated with FDA GMP non-compliance.

Competitive factors always loom. Bringing the next blockbuster drug to market is often more than just discovering the formula; it is also tantamount that the processes involved in testing the drug be performed without a hitch. A hold in the process can kill projected marketshare and future profits. A real-time best practices CIS that manages current, accurate material inventory data supports the entire clinical testing process.

Best Practices Inventory Systems Optimize Processes

Pharmaceutical Pilot Plants in particular can benefit from being able to access an accurate listing of all the approved material in their facility. A best practices CIS keeps track of where chemicals are and how much are available, as well as generates reports listing chemicals by location, vendor, name, CAS number, formula, etc., and quickly accesses hazard information during an emergency.

White Paper Identifies Critical Components

To help ensure that you know all the components of an effective CIS and how to make it work for you, get a copy of ChemSW's white paper entitled Chemical Inventory Systems Enable Pharmaceutical Pilot Plants to Accurately Manage Chemical Inventory Information in a Regulated Environment which details best practices in chemical inventory management, how a CIS integrates into an existing IT infrastructure, how pilot plants can leverage a CIS to maximize their processes, and the importance of ensuring that the CIS has the attributes for accurate validation as well as compliance with FDA 21 CFR Part 11.

To request your copy, click here.