Good laboratory practice compliance is difficult to attain yet it is vital to the success of laboratories and other companies that are required to meet FDA good laboratory practices. Fortunately, there are electronic systems that facilitate GLP compliance.
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Good laboratory practices, according to the Organization for Economic Co-operation and Development (OECD) Principles of GLP and national regulations, refers to a system of management that ensures laboratories and research organizations are maintaining consistent and reliable results. Hence, GLP is not only an analytically sound practice, but it is mandated by the Food and Drug Administration (FDA). The ultimate purpose of GLP compliance is to assure quality, traceability, integrity, and validity of test results.
GLP compliance comes with a host of challenges. Disconnected processes, slow turnaround, poorly configured in-house systems, inefficient tracking, and exorbitant hours spent setting up and learning document management systems are just a few of the common obstacles to adequate GLP compliance. Communication breakdowns often cause critical delays in product development and missing paperwork creates significant delays in sequential processes. And in the instance of manual systems, bottlenecks are almost impossible to identify and avoid. But however daunting GLP compliance may seem, there are automated solutions that have been specifically engineered to help companies in regulatory environments meet the requirements of GLP guidelines and eliminate compliance concerns . A software solution designed to facilitate GLP compliance can provide your organization with an electronic system for collecting, organization, and reviewing all the documents required to meet FDA, ISO, and CAP requirements.
MasterControl was the very first content management system provider to offer software that directly addresses the challenges of good laboratory practice compliance. Our software applications -- such as GLP audit, GLP training, and other applications -- are integrated and easy to use. MasterControl’s GLP compliance software is specifically preconfigured according to regulatory standards and industry best practices to better help you organize and control standard operating procedures (SOPs), policies, work instruction, and other similar documents that labs need in order to meet regulatory requirements. MasterControl offers companies an affordable means of automating document control processes and simplifying document collaboration, approval, and review.
Consider whether or not your organization could take advantage of the benefits of MasterControl, such as:
MasterControl GLP compliance-specific solutions include:
GLP compliance software solutions from MasterControl reduce the total cost of ownership because no special equipment is required. The preconfigured software can be customized to meet new requirements as your company proceeds through its growth cycle. MasterControl also offers a validation approach that dramatically cuts the time, pain, and cost involved in software validation. In addition, MasterControl is web-based so it can connect all involved parties from virtually anywhere in the world. Plus, it is secure so companies are able to manage critical information throughout the entire product lifecycle. Other features of MasterControl’s GLP compliance-oriented software solutions include electronic approval signatures, time-stamped audit trails, revision control, automated conversion/publishing to PDF end-to-end through a document’s lifecycle, and all necessities for compliance with the FDA’s 21 CFR Part 11 requirements.
MasterControl software is world renowned for being easy to implement and easy to use. Software solutions from MasterControl allow companies doing business in GLP compliance environments to get products to market faster while reducing overall costs and increasing internal efficiency.
For more information about standards for GLP or software for ensuring GLP compliance, please feel free to contact a MasterControl representative.