Autocal Ireland Limited is an Irish owned and managed company providing consultancy services to the Pharmaceutical and Healthcare industries. Our clients include API manufactureres, medical device manufacturers, bulk ingredient manufacturers, Bio Tech, sterile fill/finish, laboratories and hospitals.
Validation Engineers working at Autocal range from Microbiologists and chemists to Electrical and Mechanical Engineers. All of our engineers have pharmaceutical validation experience and have worked on projects under regulatory scrutiny.
Our services include:
Execution of thermal qualification of processes such as autoclaves, SIP, de-pyrogenation, stability chambers, incubators, etc. including derivation of Protocols, on-site execution of tasks and completion of reports. All work is performed to comply with the current requirements of IMB, FDA, MCA, etc. and each engineer has a full grasp of the applicable standard, e.g. HTM series, ISEN 554, ISEN 285, CFR's, EP/BP/USP, ISO11134, etc.
Project Validation Engineers
Engineers are placed on long term projects with clients where they will be responsible for many aspects of the validation life cycle for equipment procurement, installation and qualification. This can vary from protocol generation for URS, DQ, FAT, SAT, IQ, OQ, PQ to execution of same. The role of these engineers includes system design, integration and qualification. Placements can vary from 6 months to 24 months.
Computer System Validation
With a competent understanding of the requirements of ISEN 60601, GAMP IV and 21CFR part 11, our engineers provide a computer system validation solution to clients for both new projects and retro-qualification.
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