I am a systems analyst. I am changing industries but see that requirements in one industry have been or are familiar to me. I worked under government contracts and now I am moving into the Pharmaceutical industry. Are they that different?

by E.R. Williams

Not unusual. It's very interesting to me to hear the above question from third party or individuals in one industry. Just as there are commonalities in managing projects (although each project is unique), many standards' requirements are similar to other industries.

Knowledge gained from another industry and its standards can contribute to success in another industry. Take for instance in the Pharmaceutical industry. Often times a professional seeking employment or a contract is required to have certain system requirements experience including software/application development, quality assurance and/or validation for computer systems, and other environments. The employer may require experience with GXP (e.g., GCP, GMP, etc.)You find that the terminology and names are different but content is familiar to you. When you examine the requirements directly by studying the regulations and standards you see that the content (requirements) are very similar requirements used in DOD, IEEE, and aerospace standards and regulations for development. Why?

Why? I have managed projects and programs in several industries but let me share a story. When I first began to manage projects in the Pharmaceutical industry it was because I was part of a team reviewing a contract/proposal requirements. The documents imposed on the prime contract seemed to be familiar to me. I inquired after reading the draft documentation where and who wrote it, along with a request to talk with the team representative. When I got the opportunity to talk with the individual, he seemed to understand that I had the knowledge required. He showed me the documentation that was the boilerplate for the work (contract) documentation. Ah ha, it was DOD/MIL documentation that had been modified and tailored to fit the requirements for the (this particular project). What I am really saying is that many Pharmaceutical, commercial IT and project management standards and requirements (imposing management and quality/quality assurance, and configuration management), use standards that have been applied to their industry but originated some from DOD, MIL, and aerospace standards and requirements. Understand that there is nothing wrong with this fact because DOD/MIL/aerospace have also used commercial innovations and standards. Use business analysis to understand the particular company and industry but realize that many individuals have much of the knowledge that is required in the Pharmaceutical and /commercial IT having worked in another industry.

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