What Do You Need to Know about GLP Compliance Guidelines?
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.
Accelerating GLP Compliance through Automation
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.
How MasterControl Can Help You with GLP Compliance
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:
- Connected processes: Since MasterControl is an integrated solution that connects users, documents and processes in a single centralized system, it vastly improves communication and efficiency and ensures that goals and objectives are met and completed in a timely manner.
- Faster turnaround: MasterControl automates version control, document routing, follow-up, and escalation of document review and approval processes. In addition, it also automates the management of annual reviews.
- Work Acceleration through Preconfiguration: Since MasterControl is preconfigured to organize SOPs, policies, and work instruction documents for labs and blood/organ/tissue bank operations, it helps these types of organizations to streamline their processes.
- Out-of-the-box functionality: MasterControl software works right off the shelf and requires minimal system administrator or user training. LDAP integration is also available, if so desired.
- Automated tracking: The MasterControl GLP compliance software system tracks a document through collaboration, review, and approval steps. This allows the document owner to efficiently move the document through these processes and get work on the documents completed quickly and efficiently.
MasterControl GLP compliance-specific solutions include:
- Document Control/ Document Management
- Corrective Action, Preventive Action (CAPA)
- GLP Change Control
- GLP Training Management
- Software zur Automatisierung des Managements von Nichtkonformitäten
- GLP Compliance Audit Management
- Process Automation (forms-based)
- Elektronische Zulassungsanträge und andere Vorlagen
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 on Good Laboratory Practice Compliance
For more information about standards for GLP or software for ensuring GLP compliance, please feel free to contact a MasterControl representative.