Research and Development (R&D) Software Systems
MasterControl's Research and Development Software Systems are designed for Automating R&D Audit and Related Quality Processes
The MasterControl Audit™ research and development software solution offers unique functionality across and between research and development quality groups. The software facilitates quality and compliance oversight of quality activities and related facets such as environmental safety, corporate policies/procedures, computer systems usage, pharmacovigilance/product safety, third party evaluations/assessments, regulatory inspections, CAPA, nonconformances, customer complaints, and regulatory governance.
Features of MasterControl's Research and Development Software System
Specific areas of focus of the R&D system include:
- GLP: The MasterControl research and development software solution's Good Laboratory Practice (GLP) module contains all the functionality necessary to meet OECD requirements for the regulated master schedule, QA statements, and multi-site studies. The research and development software system available from MasterControl also includes a study-based process inspection management tool, and it is specifically designed to assist quality groups working under the non-clinical Good Laboratory Practice (GLP) requirements of OECD, FDA CFR Title 21, and CFR Title 40.
- GCP: The Good Clinical Practice (GCP) module generates the GCP compliance statement. The GCP component of the research and development software solution has been specifically designed to help quality groups working under the GCP requirements of ICH GCP and ICH GCVP.
- GMP: The Good Manufacturing Practice Module (GMP) component of the MasterControl research and development software system can be used for batch release reviews and is designed to benefit quality groups working under the GMP requirements of FDA CFR Title 21 and 91/356/EEC.
The research and development software available from MasterControl includes the following useful GxP functionality for R&D departments doing business in stringently regulated industries:
- Master schedule
- Process-based inspections
- Multi-site capabilities
- QA statements
- Audit certificates
- 21 CFR Part 11 compliance
- Batch release
Built-in tools allow users of the research and development system to define R&D quality activities, processes, and workflows. MasterControl's solution also allows users to separate similar functional groups by forming distinct business areas within a regulated discipline. Authorized users can be contained within a single business area or granted access to more than one business area, with the same or different roles. Each business area can be configured to give as much standardization, or as much flexibility, as the organization needs. The system's users can share as much - or as little - data as necessary within and between business areas. This allows each department to better meet long-term corporate objectives.
Benefits of the MasterControl Research and Development Software System
- Life Sciences-specific Features: MasterControl is a demonstrated leading global provider of research and development software solutions for quality groups doing business in highly regulated industries. More than half of the top 20 pharmaceutical companies' audit groups rely on MasterControl research and development software for quality management within R&D groups.
- Simplification through Automation: The MasterControl solution's web-based response features allow personnel to electronically receive findings and comments, respond to them, and track the status of individual CAPAs. Workflows can be configured to manage follow-up and implementation status, with email reminders automatically generated as due dates approach.
- Consolidated: MasterControl R&D software unites all quality programs into a single all-inclusive system. As such, all support and validation efforts can be shared across the organization. The solution provides maximum flexibility without the need for external consultants, vendor intervention, or additional programming support. The standard off-the-shelf MasterControl research and development software offering includes all the tools necessary to hit the ground running. Users simply decide which features to use when they are needed without being required to purchase costly add-on options.
- Cost effective: MasterControl's software is intuitive and cuts training time, which brings a rapid return on investment at a low total cost of ownership. The scheduling and planning tools are also vital to maximizing resources.
- Compliant: MasterControl's R&D system is fully compliant with FDA 21 CFR Part 11. Specific functionalities related to GLP, GCP, and GMP are included within the standard off-the-shelf product. The comprehensive software is based on a flexible access security model, and provides crucial compliance-oriented features such as audit trails and electronic signatures.
- Flexible: MasterControl software has core business processes available "out of the box" and predefined built-in workflows that users can either utilize or customize to create a completely new workflow. This means that the system can easily be modified to conform to corporate policies and procedures without relying on external consultants. The long term effect is a reduced overall cost of ownership.
- Electronic Tracking and Distribution: MasterControl's paperless research and development software system incorporates full electronic activity recording and distribution features, including response receipt and CAPA tracking.
- Effective Reporting Tools: MasterControl software comes with data trending, metrics, and compliance surveillance tools that allow users to carefully monitor quality and compliance statuses. The holistic software solution incorporates trending/metrics data, risk assessment, and root cause analyses to increase the general effectiveness of quality and compliance surveillance. Numerous standard reports, as well as an ad-hoc query tool, provide comprehensive compliance analysis, CAPA conditions, and the statuses of various studies, projects, and activities.
- Language Translation Tools: The system's multi-language capabilities can translate dictionary data and display system field labels in the user's local language using either single or multi-byte characters.
- Reduced Implementation Time: Business processes are pre-mapped in the standard R&D software, thereby reducing the time actually required to implement the system.
The Definitive Research and Development Software System
MasterControl's research and development software solution is a user-configurable, validated, off-the-shelf tool designed and developed by QA professionals, for QA professionals. Whether the organization is a small start-up company, a division of a larger organization, or a corporate group, MasterControl understands your business. Regardless of the organization's size, users can configure MasterControl's R&D software to effectively and efficiently manage all quality, compliance, and CAPA programs. Versatile tools allow users to manage dictionary terminology, create custom screen labels, configure workflows, and design templates.
If your organization is responsible for GLP, GCP, GMP, environmental audits, vendor management, and/or pharmacovigilance/product safety audits, MasterControl software can be deployed as a local or global solution to meet all your R&D needs. The MasterControl solution provides a central and secure database that can be used in multiple areas with as much or as little sharing of workflows and dictionary data as the user requires.
One of the most vital features of MasterControl research and development software is that it gives companies the freedom of automated processes, replacing inefficient paper-based or hybrid systems with a proven automated solution that allows authorized users to:
- Create quality and compliance plans
- Manage resources and projects
- Write quality and compliance findings directly into the database
- Perform peer review/approval prior to issuing reports
- Electronically issue results to a document or web browser
The research and development software solution harmonizes processes between audit groups and across audit groups. Built-in regulatory compliance features (i.e., GLP multi-site study capabilities, QA statements, a GLP master schedule, audit certificates, as well as batch release, "qualified person" tools, supplier evaluation, clinical trial monitoring, and key data capture) ensure that MasterControl software meets the specific needs of all research and development quality groups.
Contact Us About Research and Development (R&D) Software Systems
To learn more about research and development (R&D) software systems, call us toll free at 800-825-9117 or contact MasterControl online.