1. Home

Regulatory compliance

Regulatory compliance is the adherence to industry-specific standards, ensuring ethical and legal operation. For manufacturers, compliance involves meeting strict guidelines from regulatory bodies such as the FDA to ensure product safety and operational integrity.

What is regulatory compliance?

The strategic goals of most manufacturing companies are to manufacture competitive products, operate profitably and grow their business in an environment of increasing globalization and elevated product development costs. This is challenging enough in itself, but for medical device and pharmaceutical manufacturers, the task is even more daunting due to the additional burden of dealing with the various facets of compliance with FDA, SEC and international requirements.

Good manufacturing practices

The core mandate that guides FDA regulatory oversight is consumer safety. As a result, the FDA has defined current Good Manufacturing Practices for both device and drug manufacturers that dictate the necessary measures that must be taken to ensure that quality systems and processes are in place to consistently produce quality products.

Related products: Opcenter Quality | Teamcenter Quality and Compliance Management | Opcenter Execution


Understand the benefits

Enhance product quality

Mandate adherence to strict quality standards, driving organizations to implement robust processes and controls, ultimately resulting in enhanced product quality.

Mitigate risk

Establish and enforce standardized practices, reducing the potential for operational, legal and reputational risks within an organization.

Increase consumer trust and market access

Demonstrate an organization's commitment to ethical practices, quality assurance and adherence to industry standards, instilling confidence among consumers and regulatory authorities.

Increase customer satisfaction

Ensures adherence to strict quality standards and ethical practices, ultimately increasing customer satisfaction by delivering safe and reliable products that meet regulatory requirements.

Reduce warranty and recall costs

Enforce standardized practices and robust quality controls, thereby minimizing the likelihood of product defects or safety issues that could lead to expensive recalls or warranty claims.

Enable openness and flexibility in support of standards

Support standards across the business, allowing organizations to adapt and integrate industry best practices seamlessly, thus promoting interoperability and innovation within the regulatory framework.

Software for Manufacturing Regulatory Compliance

The aim of addressing the manufacturing regulatory compliance challenge involves establishing a consistent, top-down strategy across the manufacturing enterprise. Software solutions for Manufacturing Execution and Quality Management tailored to the needs of Medical Device and Pharmaceutical manufacturers address these challenges.

This system enables compliance with 21 CFR Part 11, and provides a comprehensive technology infrastructure for manufacturers, effectively reducing associated costs and risks. It enables automation of manufacturing processes, creating a paperless environment for global regulatory-compliant operations, and allowing companies to maintain compliance with good manufacturing practices more efficiently and cost-effectively.

Regulatory compliance software assists global manufacturers in delivering high-quality products consistently. Through real-time visibility, enforcement of manufacturing controls and integrating feedback into product design, the platform naturally promotes global compliance. Additionally, it drives risk-based compliance management globally by fostering operational excellence and ensuring compliance with international regulatory and industry standards as a by-product of efficient, high-quality processes.

Features of regulatory compliance software:

  • FDA Regulatory Compliance with 21 CFR Part 820, Parts 210/211 and 21 CFR Part 11 for electronic records and electronic signatures.
  • Compliance with international industry standards including ISO 9001, ISO 13485, IEC 61215 and IEC 61646
  • Enterprise alignment with Good Manufacturing Practices (GMP) and Guaranteed Performance Standards
  • Reduction in Audit Findings and risks associated with non-compliance

Regulatory compliance software functionality

An effective quality compliance software solution is adaptable to existing company processes. Regulatory compliance management software integrates control functions and responsibility structures to enable a fast and effective flow of information. This results in quick identification of production trends and operational risks and the avoidance of negative consequences.

Compliance software integrates user administration to enable reliable role and function allocations for each individual user. To meet all organizational compliance needs, compliance management software must provide a highly configurable and scalable solution and create no sector restrictions. As a compliance document software solution, compliance software must support a large variety of different document types, different rights and different workflows. Compliance software should be useful to every unit within an organization, regardless of location.

Specific functionality supported by an integrated compliance software solution includes:

Training and qualification - Regulatory compliance software provides a single repository for employee training and certification, including employee training profiles, course information, job requirements, certification expiration dates, and revised training requirements.

Assessments - Compliance software enables auditing processes, including scheduling, creation, and online execution.

Calibration and preventive management - Compliance software creates schedules and offers notifications, alerts, and escalation for all calibration and equipment maintenance activities.

Supplier management - Compliance software manages supplier assessments and evaluations, identifying issues and moving them to resolution.

Environmental management - With compliance document software, manufacturers ensure complete environmental recordkeeping, including analysis of environmental aspects and impacts and tracking of environmental targets and objectives.

Occupational health and safety - Compliance management software tracks and addresses workplace incidents, monitors safety hazards and controls, and manages policies and records.

Risk management - Compliance software helps manufacturers assess and mitigate risks using thorough risk analysis and controls testing.

Learn more


Siemens’ Opcenter Quality software helps manufacturers meet their quality goals

White paper

Streamline quality and compliance using best practices