Validation Management

Analyzing data for a flawless production line

Quality assurance in the healthcare industry

Validation is particularly relevant in the pharma-medico industry, as several regulations and design proportions must be met, in the construction of the production lines.

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Validation is inevitable in any manufacturing setup within the pharmaceutical and medical industry. When validating a production line, we at PJM analyze the input generated during the
design and manufacturing process of a product, to verify that the production line is consistent and reliable enough to release the system for production.


Creating value with validation management

At PJM we work closely with our customers, to make sure, that we at PJM understand and incorporate the special needs and requirements of our customers. 

When working with the pharma-medico industry, we always consider regulatory authorities such as the FDA and EMA to seek to conduct a complete and high-quality validation according to recommended guidelines such as GAMP.

We always ensure that our customers understand how and why we use our templates. Internally, we work as a team, keeping every discipline aligned, and using our internally standardized templates to keep track of changes, updates, and deliveries. 

We continuously keep our customers in the information loop, to prevent the process from slowing down, and ensure that we are always aligned with our customers, throughout the entire validation process.


A defined line of procedure 


We use the necessary tools and concepts and follow our quality management system and guidelines to conduct a customized validation plan that discloses how the project unfolds.

Our setup is modular but will include a quality plan, traceability matrix, and test plans. The complexity will be customized to the specific project and will follow the overall steps in the V-model.

Process validation is an iterative process that we conduct simultaneously with the manufacturing. This means that we continuously gather insights and experiences during the project.

When optimizing the process from A to Z, we can facilitate the process to avoid relapses and mistakes during the project, which would otherwise be costly and time-consuming.



1. A documented plan

We can deliver complete documentation- and validation packages, customized to the specific needs of our customers. This strengthens the validation process and contributes to the overall success of the process and product outcome.

2. Comply with rules and regulations

Our validation process ensures that our customer's manufacturing setup complies with the rules of regulatory agencies such as the FDA and EMA. 

3. Build trustworthy and long-lasting partnerships

With validation management, we are dedicated to ensuring that our customers achieve the best possible outcome within every applicable regulation of the industry. With a large interest invested in our customers' success and outcome, validation serves as the foundation of a long-lasting partnership.



We always keep an open and honest dialogue with our customers because we acknowledge that every project begins and ends with our customers.

At PJM, we take pride in leading the validation and always include our customers in the entire process to ensure that we are continuously aligned throughout the production.

We know about manufacturing devices and setups – in that we are the experts, but our customers know their products inside out, and these insights are crucial when validating.

By including the customer in the entire production process, we can fit the validation requirement to the level that our customers require.


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