Audits
Compliance Audit Consulting
Today’s medical device companies face more pressure than ever to meet the increasing and evolving demands of an internal audit. Many businesses are implementing a risk assessment internal audit to identify insufficiencies, evaluate risks, and determine inspection readiness. These strategies smooth the regulatory compliance audit process and provide a greater chance of FDA audit success.
Conducting periodic internal audits is one way that many companies choose to ensure compliance with ISO standards, cGMPs and international regulations. At Regulatory Compliance Associates®, we have healthcare compliance audit expertise with both short, targeted internal audits and more substantial assessments across the quality management system. No matter what your goals are, RCA’s regulatory audits team will teach you how to prepare for an FDA audit & increase FDA inspection preparedness.
Internal Audit Services
Using an RCA audit risk-based strategy, Regulatory Compliance Associates® will help your company identify and correct compliance deficiencies and choose the best regulatory compliance audits for FDA inspection readiness.
ASQ-CQA or Exemplar Global certified auditors are available for the following medical device audits:
- Current Good Manufacturing Practices (cGMP) Compliance Audits:
- Manufacturing, Pilot Plant, Laboratory Facilities
- CAPA Audit
- FDA Audit Preparation
- FDA Audit Training
- FDA Audit Support
- Current Good Laboratory Practices (cGLP) / cGMP Compliance Audits
- Regulatory Gap Analyses
- Pre-Approval Audits
- CFR Part 11 Gap Analysis
- Risk Assessments
- FDA Audit 483 Observations
- Quality Systems
- 21 CFR 820 Audit
- ISO 13485 Audit
- Development of Inspection Checklists
- Internal Audits
- Contract Manufacturer Audits
- Supplier Audits
- Scribe Audit
- Virtual audit
- Medical Device Single Audit Program (MDSAP)
- MDSAP Compliance Audit Readiness
To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
