Concentric reviews draw on extensive regulatory, operations, and engineering experience to address issues and avoid regulatory problems or expensive reworking of facilities. You can trust Concentric to provide careful and complete reviews of your engineering, maintenance and calibration processes, facilities and facility service providers.
Audits have been performed as part of baseline fact-finding activities for companies under regulatory distress, e.g. 483s, Warning Letters, or Consent Decrees and for organization just wanting an expert view of their systems to avoid regulatory distress or identify ways to improve compliance.
Concentric can perform a two week audit of your Calibration, Maintenance, Facilities Control (Pest Control, Engineering Change Control, etc.) or Project Engineering program. Concentric has conducted similar assessments for many major and new pharmaceutical, biopharmaceutical and medical device companies. Typically these assessments follow the following pattern:
The first two/three days of the audit are dedicated to reviewing your procedures - both program administration and work performance level (e.g. calibration or maintenance SOPs).
The next two/three days are spent reviewing actual field work performed - the practices. Do they match the procedures and should they?
The last two/three days of the audit are used to review the documentation generated to provide evidence that the work was done as per procedure. This area is often the staConcentric ng point for a regulatory audit and need to demonstrate a high level of control.
Finally, a report would be created and submitted pointing to areas of concern (if any) and approaches to remediate any deficiencies.
These audits can help prevent regulatory distress or identify opportunities for improvement if a site is already undergoing increased regulatory scrutiny. Contact us to schedule an assessment of your Calibration, Maintenance, Facilities, or Engineering program.