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Indentifying risks before a regulator can be most cost effective.

 

 

 

Compliance Audits

PTS reviews draw on extensive regulatory, operations, and engineering experience to address issues and avoid regulatory problems or expensive reworking of facilities. You can trust PTS 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.

PTS can  perform a two week audit of your Calibration, Maintenance, Facilities Control (Pest Control, Engineering Change Control, etc.) or Project Engineering programs.  PTS has conducted similar assessments for many major and new pharmaceutical, biopharmaceutical and medical device companies.  Typically these assessments follow the following pattern:

First part of the audit is directed to reviewing your procedures - both program administration and work performance level (e.g. cleaning, manufacturing, calibration or maintenance SOPs). 

Next part of the audit reviews the practices as performed.  Do they match the procedures and should they? This is often combined with the following segment

The closing 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 starting point for a regulatory audit and needs 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.  Please contact PTS to schedule an assessment of your Calibration, Maintenance, Facilities, or Engineering programs.

 

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Pharmaceutical Technical Services 2015