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Quality Assurance & Quality System Services

Whether you are implementing a brand new Quality System or overhauling an existing quality system, PCS has the experience to help you optimize your system. We strive for small, lean and user-oriented quality systems.

Used by

Abbott
Roche
Pfizer

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Why you should choose PCS for your next QA project

  • More than 30 years experience in GMP & GDP quality systems
  • We stick to the essence: your process, people and the patient
  • We know what the government inspects and expects
  • We are up-to-date on all the major regulatory frameworks
  • We can assume the role of Quality Assurance, where required

Quality Assurance Services

GMP or GDP quality systems are the highest standard in quality management. Show regulators, clients and stakeholders your commitment to patient safety, quality and reliability.

At PCS we help pharmaceutical organizations with implementation, optimization or replacement of Quality Management Systems. We are familiair with most international regulatory guidelines such as; EU GMP, EU GDP, U.S. FDA GMP and WHO GMP.

If required, we can assume full control over the quality system and run it for you. This is mainly applicable to smaller organizations who lack resources to staff a QA department. PCS runs quality systems for a number of Dutch and U.S. based organizations.

Receive our free QA services whitepaper in your inbox, download this whitepaper and discover:

  • The full scope of our QA services
  • Quality Assurance training options
  • Quality As A Service

Click this button to download the whitepaper:

Purchase a quality system

Most companies have their own distinct quality management system. However, in some cases, it is more expedient and cost-effective to start out with a standardized set of documents.

To help companies that want to utilize a time-tested quality system that has withstood numerous regulatory inspections and client audits, PCS offers a standardized set of GMP and GDP procedures. Contact us to learn more about pricing and which procedures are included.

Jaap Koster, CEO of PCS, avatar

Many companies focus too much on the periphery of quality; deviations, change control, etc. By building your quality system around your primary process, you spend time on proactive rather than reactive quality.

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

Quality as a Service

For companies that operate on a small scale, are in the startup phase or have trouble finding personnel PCS offers Quality as a Service.

Quality as a Service is a concept where PCS assumes operational control over your QMS.

  • We execute the tasks in the quality system,

  • We maintain the quality system,

  • We perform QMR's, PQR's and ensure that suppliers are qualified,

  • We perform qualification audits,

  • We answer to your management.

Interim QA Management

PCS has interim QA personnel that can help out in case of a shortage in QA staff or when a temporary boost in capacity is needed. When a change in the quality culture at your company is needed; installing an expert interim QA manager is also an option that we often provide.

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Get in touch with us.

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Frequently asked questions

What are the average rates for your QA consultants?

Rates vary between €75 and €125 per hour for junior to medior consultants, while senior QA consultants - with the ability to guide quality transformations - can go up to €200 per hour. Get in touch to discuss your project in detail so we can provide you with the most competitive rate.

Ready to get started?

We are happy talk about your project. During this meeting, one of our GxP experts will go over your QMS, your wishes and our working methods. After this conversation we will make a tailor-made offer.

  • More than 30 years experience in GMP & GDP quality systems
  • We stick to the essence: your process, people and the patient
  • We know what the government inspects and expects
  • We are up-to-date on all the major regulatory frameworks
  • We can assume the role of Quality Assurance, where required
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