Written By: Monica Short, Business Development Manager

  • Can you meet new compliance requirements?
  • Is your growth outpacing your resource capacity?
  • Are there roadblocks in your quality assurance or regulatory pathways?
  • Have changes to regulatory guidelines impacted your quality assurance and regulatory strategies?
  • Have you changed suppliers, vendors, or manufacturing processes recently?
  • Have you added a new line to your manufacturing facility?
  • Are you planning to move?
  • Are you prepared for your next inspection or audit?
  • Are you prepared for an unannounced FDA inspection?

Staying current in a fast-paced, regulated environment can be daunting.  You need to know your strengths and weaknesses.  How?  You can use a three step process to monitor for gaps, assess how critical those gaps are, and decide where, when, and how you can make improvements.

Step One – Understand your current state and future requirements or activity.  Review your current state.  Review your current activities, future requirements, desired states, targets, goals, and objectives.

Disinfectant Efficacy Testing

Step Two – Perform a gap assessment. Identify the gaps between where you are now and where you want to be.  Do internal or third party audits with an objective and unbiased lens.  Don’t sugar coat things.  Audit like your future depends on it, because it does.

Step Three – Make the necessary improvements to close the gaps. After you identify the gaps, prioritize and decide on the appropriate corrective and preventive actions.  Determine when you need to finish and what it will take to do the job.  You may want to enlist the assistance of an outside resource with a wide range of experience and knowledge.

Partnering with the right company can simplify the task of staying compliant. PSC Biotech brings professional services experience from more than 25 years of work with over a 1,000 clients in 31 countries.  PSC serves clients in regulated industries from globally recognized brands and multinational corporations to family-owned companies and start-up operations.

Our clients count on PSC to provide them best-in-class professional services to achieve and maintain compliance and deliver projects on-time and on budget.

  • Computer Systems and Software Validation (CSV)
  • Commissioning, Qualification, and Validation (CQV)
  • Audits, cGxP and Inspection-Readiness
  • Regulatory Affairs
  • Quality Assurance & Compliance
  • Environmental Monitoring
  • Engineering
  • Technical Writing
  • Project Management
  • Calibration and Thermal Mapping

How can we assist you, your team, and your organization? Contact PSC today! Let’s get started on toward Compliance success.

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