QUALITY ASSURANCE IN THE PHARMACEUTICAL AND MEDICAL INDUSTRY

 

Validation is a critical process in any manufacturing setup within the pharmaceutical and medical sectors. At PJM, we meticulously analyse the data generated during the design and manufacturing process of a product. This enables us to verify that the production line is consistent and reliable enough to be cleared for production.

 

Validation is essential in the pharmaceutical and medical industries, where strict regulations and design specifications must be met in the construction of production lines.

 

CREATING VALUE WITH VALIDATION MANAGEMENT

At PJM, we collaborate closely with our customers to ensure that we fully understand their unique needs and requirements.


When working within the pharma-medical industry, we take in-to account the regulations of authorities such as the FDA and EMA. We adhere to recognised guidelines such as GAMP5 to carry out high-quality and complete validations.


Our commitment to transparency means we always ensure our customers understand how and why we use our templates. Internally, we work as one team, ensuring all disciplines are aligned. We use standardised templates to track changes, up-dates, and deliveries, ensuring consistency throughout the process.

 

We keep our customers fully informed, preventing slowdowns and ensuring alignment throughout the entire validation process.

INTEGRATED VALIDATION AND DOCUMENTATION SERVICES

To enhance our service offering, PJM has consolidated vali-dation and documentation into a single dedicated department, led by Tanja Lykke Petersen, Manager of Documentation & Validation Management. Click here to read more about the vision that Tanja has for the future of Validation Management.  


This strategic integration ensures that our customers receive comprehensive, compliant packages that seamlessly fit into their validation frameworks, reducing complexity and saving valuable time during project integration. By uniting these competencies, we provide solutions that meet exact requirements, facilitating smoother operations and reinforcing our commitment to delivering high-standard solutions.

A DOCUMENTED PLAN

 

We provide comprehensive documentation and validation packages tailored to the specific needs of our customers. This strengthens the validation process, ensuring the success of both the process and the product outcome.

REGULATORY COMPLIANCE

Our validation process ensures that your manufacturing setup meets the requirements of regulatory agencies such as the FDA and EMA.

LONG-LASTING PARTNERSHIPS

We are committed to helping our customers achieve the best possible outcomes, fully compliant with industry regulations. Validation is the foundation of a long-lasting partnership, driven by our investment in our customers' success.

A DEFINED LINE OF PROCEDURE

We follow a clearly defined process using the necessary tools and concepts as part of our quality management system and guidelines. We develop a custom validation plan that outlines the steps of the project.


Our setup is modular but will always include a quality plan, traceability matrix, and test plans. The complexity is tailored to the specific needs of the project, and all steps follow the framework of the V-model.


Process validation is an iterative process conducted along-side manufacturing. This allows us to gather continuous in-sights and feedback throughout the project. By optimising the process from start to finish, we can avoid costly and time-consuming mistakes and ensure a seamless workflow.

EVERYTHING BEGINS WITH THE CUSTOMER

At PJM, we believe in maintaining an open and honest dialogue with our customers. We understand that every project begins and ends with our clients.


While we are experts in manufacturing devices and setups, our customers are experts on their products. This insight is invaluable in the validation process. By involving the customer throughout the entire production process, we can tailor the validation requirements to meet the specific needs of each client.

WANT TO KNOW MORE ABOUT VALIDATION MANAGEMENT? 

 

If you need expert support with validation management to ensure full compliance with regulatory requirements, our experienced team is ready to guide you through every step of the process. Feel free to reach out by using the form below. 

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