Laboratories Clinical and Medical
Integrated Quality Management Software - Automate Paper-based Clinical or Medical Laboratory Quality Processes and Comply with CLIA, CGLPs, CGMPs, and Other FDA Regulations
Whether the goal is R&D or medical testing, laboratories play an essential role in the prevention, diagnosis, and treatment of diseases and in the overall delivery of health care. Like other life sciences industries, labs invest heavily in research and development of new technologies. Most of all, labs must ensure the quality, accuracy, and integrity of test results and other laboratory data.
Clinical labs must comply with the Clinical Laboratory Improvement Amendments (CLIA) to be certified to perform testing on human specimens. Labs involved in development of new tests and technologies and in clinical studies also must comply with FDA regulations. FDA-regulated labs maintaining electronic record-keeping systems must comply with 21 CFR Part 11. Public companies or those planning to go public or are acquired by public companies are covered by Sarbanes-Oxley Act (SOX) requirements.
A laboratory's ultimate goal is to ensure the accuracy and quality of tests. To achieve this goal, the lab must address many challenges, including:
- Inefficient Quality System: Labs with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during inspections.
- Disconnected Processes: Quality processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA, training, and other quality processes is likely to cause delays in change implementation.
- High Cost of Validation: High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a lab successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.
Compliance is a state, not an event. A laboratory must not only attain compliance, but sustain it year after year. The MasterControl? integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost-effective manner.
Recognizing that validating a software solution ? and keeping it in a constant state of validation ? is half the battle in sustaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
Roll over the list of solution categories below to view the related MasterControl product, then click to go to that solution's product page.
MasterControl Documents™ helps increase the efficiency and effectiveness of each department by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy.
MasterControl Change Control™ streamlines the entire
change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high.
MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees.
Training control can be integrated with the rest of the
quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
MasterControl Submissions™ facilitates electronic delivery of
FDA applications (such as IND, NDA, and BLA) by providing control in assembling and tracking necessary documentation. It provides appropriate templates to streamline the dossier-creation process. MasterControl can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process, to accelerate submissions.
MasterControl Customer Complaints™ streamlines the complaint-handling process and reduce the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue.
The
FDA's
21 CFR Part 11 requires full-cycle validation of electronic record-keeping systems to assure the accuracy, reliability, and consistent intended performance of the system.
MasterControl GCPDocs JumpStart™ provides a solution for collecting, organizing, and reviewing all the documents required to meet
GCP requirements.
MasterControl Supplier™ gives companies the capability to efficiently manage and approve vendor lists and effectively track supplier
quality and supplier status.
MasterControl Batch Records™ is a powerful EBR management solution for automating and controlling batch processes. This automated EBR system will help ensure
GMP compliance and increase efficiency in creating and managing master recipes and control recipes. For manufacturers automating their paper-based batch record systems for the first time, MasterControl meets all software-related requirements of
Part 11.
Nelson Laboratories
