Regulatory

Regulatory Management Software for Life Sciences Manufacturers

Streamline Compliance Operations and Simplify Quality Processes With Regulatory Compliance Software Systems

For life sciences manufacturers subject to stringent industry regulations, regulatory management software has become an indispensable tool for managing both internal and external regulatory inspections of quality processes. Regulatory compliance software designed for life sciences compliance enables manufacturers to efficiently identify outstanding actions, quickly address issues, and effectively respond to all aspects of a regulatory authority's inspection focus.

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Free Regulatory Management Resources

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White Paper: 6 Must-Haves for a Quality Management System (QMS)
Industry Brief: 21 CFR Part 11: 7 Ways to Avoid Noncompliance
Summary: ISO 9001 Compliance Requirements Summary: ISO 13485 Compliance Requirements
FAQ: 21 CFR Part 820 – ISO 13485 Harmonization
Data Sheet: MasterControl Documents Data Sheet: MasterControl CAPA

Benefits of Regulatory Compliance Software for Life Sciences Manufacturers

Regulatory management software serves two primary purposes in the life sciences industry: controlling the flow of quality information and effectively managing compliance documentation. In the highly regulated environment of life sciences manufacturing, a proven and comprehensive software system must meet both local and global regulatory compliance requirements while allowing users to:

· Electronically manage quality activities specific to life sciences manufacturing.

· Handle process-based inspections and audits in compliance with industry standards.

· Maintain status information on suppliers, vendors, and third parties crucial to the supply chain.

· Support qualified personnel with expanding review responsibilities in a good manufacturing practices (GMP) environment.

· Meet the challenges of good laboratory practices (GLP) multi-site study requirements for R&D operations.

· Manage clinical trial site information, including Institutional Review Boards (IRBs) for pharmaceutical manufacturers.

· Provide electronic GLP master schedules for research-based organizations.

· Perform batch releases in accordance with regulatory requirements.

· Issue quality assurance (QA) statements and audit certificates to maintain compliance.

When implementing regulatory compliance software, life sciences manufacturers should be able to easily develop detailed inspection plans that can be readily shared with appropriate authorized parties. An effective system should also offer flexibility in programmability and allow for electronic prompt updates to remind users of planned, current, and outstanding activities. Additionally, a scoring system that helps quality auditors assign ratings based on assessments of the criticality, frequency, and impact of a finding can be particularly beneficial in the life sciences sector.

MasterControl's Regulatory Management Software for Life Sciences

MasterControl's regulatory management software system includes all the aforementioned features relating to quality inspections in life sciences, plus it provides users with the ability to:

· Directly enter and categorize findings specific to life sciences compliance.

· Attach supporting evidence as applicable to regulatory requirements.

· Perform peer reviews in line with GMP practices.

· Approve reports prior to issue, ensuring regulatory alignment.

· Issue into a secure web browser or document for direct entry of responses and actions.

· Analyze root causes of quality issues in manufacturing processes.

· Perform risk assessments tailored to life sciences industry standards.

· Enter auditor-specific notes relevant to regulatory inspections.

Bonus Features of MasterControl's Regulatory Compliance Management Software System

Proven Solution Designed for Regulatory Environments: MasterControl is a worldwide leading provider of regulatory compliance management software systems for quality teams in highly regulated industries. More than half of the world's top 20 pharmaceutical companies' R&D groups, for example, depend on MasterControl's systems to meet their quality management needs.
Comprehensive, Integrated System: MasterControl's software unites all quality programs into a single all-inclusive system, which means all support and oversight efforts can be shared equally across the enterprise. The system provides maximum flexibility without any need for vendor intervention, external consultants, or additional costly programming. The solution includes all the necessary tools within the standard product, right off the shelf. Customers can decide which features are most beneficial for their particular purposes without being required to purchase costly add-on options that may not be needed.
A Cost-Effective Solution: MasterControl is intuitive and reduces training time, which immediately results in a positive return on investment at a remarkably low total cost of ownership. The MasterControl regulatory compliance management software’s scheduling and planning tools also help to maximize resource usage.
Sustained Compliance: The interconnected MasterControl software is based on a flexible access security model and provides essential compliance-oriented features such as audit trails and electronic signatures. The system is also fully compliant with U.S. 21 CFR Part 11. Specific functionality related to GLP, good clinical practice (GCP), and GMP is included with the standard off-the-shelf product.
Flexibility: At its core, MasterControl's regulatory compliance management software system contains built-in flexible business processes and also incorporates predefined workflows that customers can implement as is or customize to formulate a completely unique workflow. This cost-reducing malleability allows users to easily update the system to conform to internal procedures without requiring any assistance from outside consultants or other third parties.
Electronic Tracking and Distribution Activities: Since it is a completely paperless solution, MasterControl makes ideal use of fully electronic activity recording and distribution features, including response receipts and automated CAPA tracking.
Powerful Reporting Tools: MasterControl regulatory compliance management software comes complete with robust data trending, metrics, and compliance surveillance tools that allow users to observe quality and compliance statuses. The software incorporates trending/metrics data, risk assessment, and root cause analysis tools to enhance the overall effectiveness of quality and compliance supervision.
Language Translation Tools: The MasterControl regulatory compliance management system's language capabilities are useful for translating dictionary data and displaying system field labels in the user's local language. Global deployment is also simplified by the solution's multiple language capabilities, which include single - and multi-byte characters.
Reduced Implementation Time: Business processes are pre-mapped in the standard out-of-the-box system, which minimizes the time needed to implement the software.

The Value of a Web-based Regulatory Compliance Management Software System

MasterControl's regulatory compliance management software system gives companies the freedom of automated quality processes and allows them to replace inefficient, outdated paper-based systems with a high powered electronic solution. MasterControl allows users to:

Create quality and compliance plans
Effectively manage resources and projects
Write quality and compliance findings directly into a central database
Perform peer review/approval prior to issuing reports
Electronically issue results to a document or web browser
Remotely record findings

The MasterControl regulatory compliance management software system's web-based response features allow personnel to electronically receive findings and comments, appropriately respond to them in a timely manner, and track the status of individual CAPAs. Workflows can be configured to manage follow-up and implementation status and email reminders can be automatically generated as deadlines approach.

MasterControl's multiple standard reports - as well as an ad-hoc query tool - provide users with compliance trends, metric analyses, and CAPA status reports, as well as the statuses of studies, projects, and activities. Security features, audit trails, and adherence to U.S. 21 CFR Part 11 guidelines are all standard components of MasterControl's software.

Learn More About Regulatory Compliance Management Software Systems for Life Sciences

For more information about modern regulatory compliance management software systems for life sciences companies, contact a MasterControl representative today.[JJ1]