Validation Services

Developing precision documentation and perfecting your operations for GxP compliance throughout the product lifecycle

Dor’s validation services help pharmaceutical manufacturers, medical device companies, logistics firms, hospitals and start-ups produce accurate documentation to confirm that facilities, equipment, systems, processes and devices meet international regulatory requirements.

Get quick, quality support to comply with regulatory, industry and quality standards

With Dor’s comprehensive validation program, gain the assurance and written records that your entire operation will produce reliable and consistent quality outcomes every time, as required by FDA, EU and other regulations, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Laboratory Practices (GLP).

Dor helps organizations perfect their businesses and take effective corrective and preventive action (CAPA) to eliminate non-conformities at the source.

Compliance validation and training for:

  • 21 CFR Part 11
  • 21 CFR 820
  • Regulation 126 (נוהל 126)
  • Regulation 130 (נוהל 130)
  • Regulation 135 (נוהל 135)
  • GAMP 5
  • ISO 13485:2016
  • ISO 9001

Dor Services

Dor introduces best-practice validation services aligned with each customer’s needs – as either turnkey solutions or targeted project assistance.

Validation planning

Develop a validation
master plan – a
roadmap specific…

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Develop a validation master plan – a roadmap specific to your organization that defines how and when the validation program will be executed in order to achieve and maintain a qualified facility.

Validation project management

Direct validation master
plan activities to make
sure that operations…

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Direct validation master-plan activities to make sure that operations and documentation are in complete compliance with all regulations. Oversee documentation development, testing and corrective actions, keeping the project on track

Validation

Prepare documentation
as evidence of the
operation and execute

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Prepare documentation as evidence of the operation and execute the process. Highlight the steps on the critical path and evaluate how to streamline the process in order to accelerate the operation, prevent delay, reduce costs and correct activities vulnerable to error.

Risk analysis

Assess work,
manufacturing and
distribution processes…

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Assess work, manufacturing and distribution processes, as well as materials, facilities, systems and equipment to determine areas of exposure, the impact and severity, and propose corrective action. A supplemental gap analysis evaluates alternatives and recommends feasible options within the organization’s risk tolerance.

Audits and regulatory compliance assessments

Perform complete or
select evaluations of
process, system and…

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Perform complete or select evaluations of process, system and equipment documentation to determine whether it matches the actual operation and complies with regulatory requirements. Prepare organizations for validation compliance audits.

Systems, software and equipment qualification

Conduct equipment and
computer system
validation (CSV) to…

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Conduct equipment and computer system validation (CSV) to ensure that these technologies perform according to functional requirements and standard operating procedures and maintain data integrity. Qualification covers: design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) for 21 CFR Part 11 and GAMP 5 (Good Automated Manufacturing Practice) standard compliance.

Standard Operating Procedure (SOP) writing and review

Develop or evaluate
step-by-step
instructions to perform…

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Develop or evaluate step-by-step instructions to perform routine operations across the value chain, and document in a simple standard format. Recommend revised processes, alternative infrastructure, state-of-the-art equipment and other elements to streamline activities, reduce risk and save resources. The scope covers raw materials, production, packaging, labeling, storage and logistics, including all facilities, materials movement, human resources, sanitation and vehicles.

Change management

Implement updated
processes, technologies,
job roles and…

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Implement updated processes, technologies, job roles and equipment using a systemic, detail-oriented approach that plans, documents and tests the changes. Ensure a smooth transition, minimizing disruptions and maximizing resource efficiency. Incorporate effective communication strategies to support employee buy-in and project success. Conduct a post-implementation review to confirm effectiveness.

GMP and GDP training

Deliver a range of
courses from basic
introduction to…

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Deliver a range of courses – from basic introduction to advanced GxP – with special attention to the validation process. Focus on company empowerment and knowledge acquisition to promote future independence. Customized classes are designed to meet customer needs, and targeted training introduces new regulations and industry standards.

Medical device validation

Get the support to obtain
clearance to market for all
class machines and all levels…

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Get the support to obtain clearance to market for all class machines and all levels of regulatory scrutiny. Prepare and submit documents, and respond to inquiries during all device-development phases, from engineering and product specification, to design and testing, and from manufacturing to upgrades. Fast-track the US FDA (21 CFR 820), EU CE Marking and ISO 13485:2016 approval processes.

eProcurement audit

Review your end-to-end ecommerce
infrastructure from order to delivery
to ensure that it has airtight…

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Review your end-to-end ecommerce infrastructure – from order to delivery – to ensure that it has airtight supply chain controls that maintain transparency and are compliant with ever-emerging regulatory and industry standards.

Get pragmatic and creative solutions from specialists with a wealth of validation experience

Dor professionals are seasoned experts with intimate validation knowledge from years of experience in clean room processes, systems and equipment, as well as production, storage, distribution and transportation.

With Dor, you get a big-picture view. Dor has a keen ability to identify implications on the entire operation, assess trade-offs and make recommendations to shorten the value chain and identify financial and resource savings. For example, with small-scale product batches, Dor evaluates implementing single-use system (SUS) to shortcut high-risk processes.

Dor’s Senior Auditors can help customers avoid common and uncommon pitfalls in the approval process.

Forward-looking expertise

Dor has its finger on the pulse of emerging regulations to help you remain in compliance over the long term.

The firm practices what it preaches with internal quality reviews to ensure that customers are getting the benefit proposed from services provided.

Empowering customers to promote independence

Dor prides itself on truly listening to customers, understanding their vision, needs and concerns – and customizing solutions to each situation. With results-oriented projects, Dor’s goal is to help organizations strengthen and broaden their capabilities so they can function on their own.

A customer-focused approach to overcome regulatory barriers

Dor helps organizations gain peace of mind that they are in control and in compliance, seeing regulatory requirements as necessary quality steps, and not daunting, insurmountable hurdles. The Dor team has helped organizations exceed Ministry of Health requirements, earning three-year review cycles instead of biennial reviews.

Specialization in the supply chain and Good Distribution Practices

Since raw materials coming into a plant and finished products leaving the manufacturing site require a special level of attention, Dor has targeted expertise in logistics, including transportation, storage, refrigeration, temperature mapping, etc.

With Dor, simplify compliance with the full range of regulations and industry standards

  • Validation for Regulation 126 of the Israeli Ministry of Health: For proper refrigeration, temperature mapping and transportation (ביצוע ולידציות בהתאם לנוהל 126 של משרד הבריאות )
  • Validation for Regulation 135 of the MOH: For hospital pharmacy compliance with high-risk drug preparations – sterility for cytotoxic drug and aseptic products and preparations (ביצוע ולידציות בהתאם לנוהל 135 של משרד הבריאות )
  • Validation for Regulation 130 of the MOH: To support the full adoption of European GDP directives for pharmaceuticals – including warehousing and distribution (ביצוע ולידציות בהתאם לנוהל 130 של משרד הבריאות )