Equipment & System Division

Services

Perfect organization and executation for qualification and validation

Equipment and Systems that have a direct impact on the pharmaceutical drug quality or medical devices by GMP Law should be validated in order to demonstrate the expected performance in a reproducible way.

DOC Equipment & System Division can organize and execute qualification and validation of new or in use existing Systems; the several activities are fully traced and documented applying the Validation Life-Cycle from the User requirements to the Validation maintenance.

Equipment and Systems that have a direct impact on the pharmaceutical drug quality or medical devices by GMP Law should be validated in order to demonstrate the expected performance in a reproducible way.

Validation Life Cycle

DOC Equipment & System Division Team is made up of Mechanical and Chemical Engineers that support our clients providing the necessary documentation and through the execution of “on site” activities covering the entire Qualification process for pharmaceutical Equipment and Systems like:

Critical utilities:

  • Water For Injection / Purified Water / Pure Steam / Process Gases (compressed air, nitrogen)

HVAC System and related controlled classified areas including:

  • Unidirectional Air Flow (LAFs) / Environmental monitoring systems (EMS) for critical parameters

Pharmaceutical Manufacturing Process Equipment for:

  • API (chemical or biological) / Solid Finished Forms / Liquid Finished Forms

Quality Control Laboratory Equipment

Services

Beside our Automated System Sub-Division made up of Computer Technicians provides the Validation of Computerized Control Systems as per Gamp 5 and 21 CFR part 11 requirements.

With the reference of the Validation Life Cycle, Equipment & Systems Division provide activities and services in the following areas:

System qualification

Equipment and systems to ensure a full compliance

DOC team has an in-depth, hands-on personal experience in qualifying pharmaceutical equipment and systems to ensure full compliance to companies that are regulated by FDA, EMA or other Agencies. Our qualification activities incorporate ISPE Baseline Guide approach and the “make-right” job attitude in order to verify any system’s critical aspect.

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Validation Maintenance

The right program for the calibration and maintenance of test and measurements equipment

FDA and EU regulations require that Firms have a program for the calibration and maintenance of test and measurements equipment. The program should include: intervals, scheduling, specific procedures, limits and remedial actions in the event that the equipment does not meet established requirements. Towards this task, DOC’s expertise and the usage of the highest calibration standards and systems helps customers to maintain the “Validated State” of their equipment and systems providing calibration services, Standard Operating Procedures, Process and System Re-validation and Change Control Management.

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Computerized System Validation

A great experience in qualifying pharmaceutical equipment and systems

Currently most of the pharmaceutical equipment is managed and controlled by computerized systems that have to be designed, developed and validated according to stringent quality standards defined by International Regulatory Bodies and Organizations like FDA, ISO and GAMP. Quality requirements impose the need for specific controls and procedures throughout the Software Development Life Cycle and the documented evidence, as stated by FDA, that “Computer Systems will consistently produce results that meet its predetermined specification and quality attributed”.

Acting in compliance with the most updated regulatory normative requirements, DOC has the Know-how and the Expertise to plan and execute Static and Dynamic Testing necessary for a successful Computer System Validation.

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