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Expert Gap Assessments and Mock Audits for Pharma Compliance

PCS performs gap assessments of pharmaceutical manufacturers or distributors. Worldwide coverage, EU, U.S. FDA or WHO regulatory requirements.

Used by

Abbott
Roche
Pfizer

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Why you should choose PCS for your next gap assessment

  • More than 300 gap assessments performed, worldwide
  • Extensive experience in the international GxP's
  • We work with qualified auditors only
  • Detailed reporting and CAPA support

Gap assessments & mock audits

PCS provides specialized services in gap assessments and mock audits, designed specifically for companies regulated by GMP and GDP standards.

In the ever-evolving pharmaceutical industry, maintaining compliance is not just about meeting regulatory requirements; it's about exceeding them to ensure the highest quality and safety of your products. Our team of experts is here to guide you through every step of the compliance journey.

Utilizing a PCS mock audit or gap assessment allows you to gain an in-depth understanding of your current quality culture and compliance status.

Mock Audits

Our mock audits simulate real-world regulatory inspections, preparing your team for the actual auditing process. This practice not only familiarizes your staff with audit procedures but also helps in identifying potential areas of non-compliance.

Gap Assessment

Our gap assessments delve into your current practices to identify areas of improvement in compliance with GMP and GDP standards. We thoroughly review your processes, documentation, and management systems to ensure no stone is left unturned.

Continuous compliance

Beyond initial assessments and audits, we provide ongoing support to ensure your company continues to meet and exceed regulatory standards.

Jaap Koster, CEO of PCS, avatar

Finding organizations adept in managing both the intricacies of technical installations and complex manufacturing processes, along with the nuanced dynamics, can be challenging. PCS offers comprehensive audits encompassing all these aspects to ensure thorough and balanced evaluations.

Eng. J.J.M. Koster
CEO of PCS

Benefits of gap assessments and mock audits

  • Risk Mitigation

    Our proactive approach in identifying and addressing compliance gaps significantly reduces the risk of regulatory issues.

  • Operational Efficiency

    Through our services, companies often discover opportunities for operational improvements, leading to enhanced efficiency and product quality.

  • Regulatory Confidence

    Preparation is key to successful audits. Our comprehensive mock audits provide your team with the confidence to handle regulatory inspections seamlessly.

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Frequently asked questions

How long does a typical gap assessment or mock audit take?

The duration varies based on the size of your organization and the complexity of your operations. Typically, a gap assessment or mock audit can take anywhere from one to five days.

Can you assist with writing or implementing CAPA's?

Absolutely. After identifying gaps or potential improvements, we can provide guidance and support in implementing these CAPA's to ensure compliance and enhance operational efficiency.

Do you provide training for our staff as part of the audit process?

Yes, part of our service can include staff training to ensure they are fully informed about GMP and GDP standards and understand how to maintain compliance in their daily operations.

Can you handle audits for international regulations outside of our home country?

Our team is experienced in a variety of international regulatory standards and can conduct gap assessments and mock audits that cater to specific international requirements.

Ready to elevate your compliance standards?

Contact us today to schedule a consultation and learn more about how we can assist your company in achieving excellence in GMP and GDP compliance.

  • More than 300 gap assessments performed, worldwide
  • Extensive experience in the international GxP's
  • We work with qualified auditors only
  • Detailed reporting and CAPA support
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