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Regulatory

Compliance Management Tools

How the right compliance management tool ensures products get approved and on the market faster.

Developing regulated products requires strict attention to many diverse details. A single error or missed step can lead to costly waste and delays. A compliance management tool:

• Provides a full view of all quality and compliance processes.

• Tracks all tasks to prevent omissions.

• Prevents costly errors.

• Keeps product releases on schedule.

An automated tool that enables you to successfully comply with all the 21 CFR Part 11 guidelines makes the regulatory pathway smoother and easier.

Free Resources

21 CFR Part 11: 7 Ways to Avoid Noncompliance

Videos Show the Advantages of a Compliance Management Tool

See how companies meet every 21 CFR Part 11 guideline with MasterControl.

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Record Tracking

21 CFR Part 11 includes guidelines about audit trails. These are needed to ensure electronic records are reliable and authentic. Your compliance management tool should create secure, time-stamped audit trails. Automatically document the identity of anyone who creates, changes or deletes an electronic record. Also track the changes and when they occur.

Ensure Compliance Throughout the Product Life Cycle.

Download these free resources and learn how to prevent gaps and errors in compliance management with MasterControl.

Free Templates: 21 cfr part 11 compliance checklist template
Industry Brief: SOP Management as a Compliance Tool in FDA and ISO Environments Industry Brief: What the Revised European Union’s Annex 11 Means to Life Science Companies

Unified Business Units

Seamless communication and data sharing across the supply chain is valuable. It prevents errors and lost information. Your compliance management tool should keep all phases of product development — quality, design, documentation, change control, training, corrective and preventive action (CAPA), etc. — organized and up to date.

Efficient Risk Mitigation

The FDA stresses the importance of quality, safe and risk-free products. Patient experiences and outcomes are common benchmarks for risk management. Your compliance management tool should enable you to proactively identify and amend risks.

Confidently Achieve and Maintain Compliance

Automate compliance management and deliver high quality, safe and effective products sooner.

Related Information

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Compliance Management Tools

Videos Show the Advantages of a Compliance Management Tool

Record Tracking

Ensure Compliance Throughout the Product Life Cycle.

Unified Business Units

Efficient Risk Mitigation

Confidently Achieve and Maintain Compliance

FDA 21 CFR Part 820

Compliance Audit Software Systems

Regulatory Information Management System (RIMS) Software

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Compliance Management Tools

Videos Show the Advantages of a Compliance Management Tool

Record Tracking

Efficient Electronic Records Management

Ensure Compliance Throughout the Product Life Cycle.

Unified Business Units

Reduce the Cost of Compliance

Efficient Risk Mitigation

Product Reliability and Integrity

Confidently Achieve and Maintain Compliance

FDA 21 CFR Part 820

Compliance Audit Software Systems

Regulatory Information Management System (RIMS) Software

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