MMS employs regionally-based compliance specialists to advise your internal teams or augment your internal staff with domestic and international GXP audits. Our clients range from top pharma with established procedures and compliance functions to virtual biotech organizations looking to establish their QMS processes prior to initiating manufacturing or clinical trials.
Covering six continents, our audit team’s experience covers a broad range of audit types and therapeutic areas including oncology, infectious disease, respiratory disease, neuroscience, virology, cardiovascular, ophthalmology, dermatology and many others. We can support your organization across all program phases: non-clinical animal studies, bioequivalence or Phase 1 through Phase 4.
GxP Compliance Auditing Services Include:
- Prequalification, Routine and For Cause Audits
- Site, Vendor, Document/TMF Audits
- Due Diligence Audits
- Systems and Process Audits
- Evaluation of specialized computer systems including validation documentation reviews and compliance check against 21 CFR Part 11
An important part of conducting domestic and international GXP audits is the review of audit observations and Corrective Actions and Preventive Actions (CAPA). MMS will assist your teams in addressing these findings following the audit or inspection. These remediation and prevention strategies can be created, assigned and tracked to prevent similar incidents from reoccurring. Responsive tactics can also be targeted to specific involved parties to guide remedial action such as coaching, training termination, or other activities.
For an organization’s compliance program to be successful, uncovering and resolving the root causes of any compliance issues is critically important. These programs should focus on prevention, in-process quality checks, root cause analysis and governance to be effective, and include a mechanism for continuous improvement.
A key requirement of planning for efficient and effective CAPA is that compliance leaders have actionable information – essential to uncovering the causes of incidents and issues – and a way to actively measure their CAPA efforts, analyze resolution and outcomes, and attain greater visibility of the progress of remediation activities along with systems development. It is important to provide insight so the enterprise can be apprised and remain vigilant.