Product Engineering Services & Solutions blending Applied Sciences with Technologies

Case Study: Regulatory Compliance

21 CFR Part 11 Requirements Gathering

Domain : Regulatory Compliance

Type : Knowledge and Consulting

BAT has supported a leading analytical instrument manufacturer for gathering requirements for 21 CFR Part 11 Electronic Records and Electronic Signatures. BAT worked with customer representatives to identify features within the analytical software that would support 21 CFR Part 11 compliance. A user requirements document and a software requirements document with the mock UI was created and made available to the development team.

Computer Systems Validation

Domain : Regulatory Compliance

Type : Knowledge and Consulting

BAT provides validation service for software that controls the analytical instruments like LC, GC, MS, etc. BAT has supported a leading contract research and testing organization that provides full service clinical research by performing computer systems validation thereby helping them fulfill the US FDA requirements. The validation activities where scheduled meticulously so that the instruments would have a minimum down time.

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  • “Shimadzu engaged Bio-Analytical Technologies (BAT) for an important addition across its software products suite. BAT designed and developed the application where we found that they are reliable service provider who treated Shimadzu as a valued customer. BAT delivered the solution with utmost flexibility yet as planned, on schedule which really made a difference to Shimadzu. At Shimadzu we definitely would consider BAT as a long term partner.”

    Ryuji Nishimoto,
    Ryuji Nishimoto,General Manager Research & Development
  • “The partnership with BAT has been a contributing factor in achieving the business goals for Waters MS division. We are pleased with the commitment and dedication exhibited by BAT practitioners and management. BAT has a team with strong domain and software life cycle expertise. BAT can be proud of its vision statement of solutions that make a difference”

    Richard Chapman,
    Richard Chapman,Waters The Sciences of What's Possible.
  • “The BAT team are very professional, we have good communication and engagement with the team who are able to demonstrate a strong mix of life science application and software technical knowledge. This balance has delivered value in practice, allowing teams to get up to speed with our projects efficiently, and deliver on commitments without the need for constant supervision.”

    Gary Coulthurst,
    Gary Coulthurst,Software Quality Assurance Brooks Life Science