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Regulatory compliance and validation services

Throughout the world the production of pharmaceuticals, biotech and API is subject to strict governmental control. Manufacturers are required to provide documented evidence that their facilities, equipment and methods meet, and are capable of continuing to meet regulatory directives.

With our proven experience in the life sciences industry and our track record in managing validation projects we can help you to:

  • Achieve regulatory compliance and optimal production
  • Support new risk-based approaches as described in GAMP5
  • Extend the validation concepts to the next generation PAT-ready control systems
  • Implement a systematic approach to pharmaceutical development and manufacturing
  • Implement continuous manufacturing (CM) operations, as preferred by FDA and EMEA

Your validation partner

ABB helps you establish documented evidence that your facilities, procedures, control systems and other equipment function in a reliable and reproducible manner and meet the current good manufacturing practices (GMP) for all pharmaceutical production.

When validating your facilities, our priority lies with identifying and rectifying those non-compliant areas that most threaten your operations. Our risk-based approach addresses:

  • Laboratory systems and equipment
  • Toxicology software, LIMS systems, spectrophotometers, chromatographs and other equipment
  • Computer systems
  • Electronic records and signatures
  • Process equipment
  • Complete system audit
  • Quality management, work methodology and control mechanisms for product release

Computer system validation

ABB’s computer system validation services actually increase your efficiency by providing consistent execution activities, documentation and solutions for all regulatory compliance issues.

ABB’s qualification as a supplier of applications for current good manufacturing practices (cGMP) is proved by a long list of references for validation projects.

We provide computer system validation documentation as indicated in the GAMP5 including the following:

  • Documentation for your vendor selection and qualification
  • Validation procedures
  • Instrument and equipment use procedures
  • PQP, FDS, IQ/OQ test protocols
  • Text execution forms
  • Traceability matrix
  • Reviews and change control
  • Ongoing services to assist you in maintaining the automated production and control system in a fully validated state

The advantages of a partnership with ABB:

  • System 800xA solutions are designed for ease of end-user validation
  • Each software and hardware module of 800xA system is easy to validate
  • Regulatory compliance is built into our system
  • Automatic version control and tracking of changes for application software and hardware configuration
  • Electronic records
  • Electronic signature and security systems in compliance with 21 CFR part 11

 

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