PharmAllies validated its LIMS system in 2022, and every change since had been assessed, approved, and correctly documented.
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The system had been validated in 2022, and every change since had been assessed, approved, and correctly documented. That was the problem. I was doing a readiness reviewโฆ
Company
PharmAllies
Commissioning, Qualification & Validation (CQV) | GxP Compliance | Computer System Validation (CSV) | Risk-Based PM
- Industry
- Business Consulting and Services
- Location
- Kenilworth, US
- Company size
- 2โ10 employees
About PharmAllies
๐๐ต ๐๐ฉ๐ข๐ณ๐ฎ๐๐ญ๐ญ๐ช๐ฆ๐ด, ๐ธ๐ฆ ๐ฅ๐ฐ๐ฏโ๐ต ๐ซ๐ถ๐ด๐ต ๐ฆ๐ฏ๐ด๐ถ๐ณ๐ฆ ๐ค๐ฐ๐ฎ๐ฑ๐ญ๐ช๐ข๐ฏ๐ค๐ฆ, we integrate it from the start. Our approach bridges the gap between ๐&๐ ๐ณ๐ถ๐ฟ๐บ๐, ๐ฟ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐ฒ๐ ๐ฝ๐ฒ๐ฐ๐๐ฎ๐๐ถ๐ผ๐ป๐, ๐๐ค๐ฉ ๐ฒ๐ ๐ฒ๐ฐ๐๐๐ถ๐ผ๐ป, ๐ฎ๐ป๐ฑ ๐บ๐ฎ๐ป๐๐ณ๐ฎ๐ฐ๐๐๐ฟ๐ถ๐ป๐ด ๐๐๐ฐ๐ฐ๐ฒ๐๐. The traditional GxP Systems delivery methodology ๐ณ๐ฎ๐ถ๐น๐ ๐๐ผ ๐ฎ๐น๐ถ๐ด๐ป ๐ณ๐ฎ๐ฐ๐ถ๐น๐ถ๐๐ ๐ฑ๐ฒ๐๐ถ๐ด๐ป, ๐ฝ๐ฟ๐ผ๐ฐ๐๐ฟ๐ฒ๐บ๐ฒ๐ป๐, ๐๐ค๐ฉ, ๐ฎ๐ป๐ฑ ๐ฟ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐ฐ๐ผ๐บ๐ฝ๐น๐ถ๐ฎ๐ป๐ฐ๐ฒ, leading to: โ ๐ข๐๐ฒ๐ฟ๐ฏ๐๐ฟ๐ฑ๐ฒ๐ป๐ฒ๐ฑ ๐ข๐๐ป๐ฒ๐ฟ๐ & ๐๐ผ๐บ๐ฝ๐น๐ถ๐ฎ๐ป๐ฐ๐ฒ ๐ฅ๐ฒ๐๐ฝ๐ผ๐ป๐๐ถ๐ฏ๐ถ๐น๐ถ๐๐ถ๐ฒ๐ โ ๐๐ป๐ฎ๐ฑ๐ฒ๐พ๐๐ฎ๐๐ฒ ๐๐ค๐ฉ & ๐๐ ๐ฃ ๐๐ผ๐ฐ๐๐บ๐ฒ๐ป๐๐ฎ๐๐ถ๐ผ๐ป ๐ฎ๐ ๐๐ฎ๐ป๐ฑ๐ผ๐๐ฒ๐ฟ ๐ง๐ต๐ฒ ๐ฃ๐ต๐ฎ๐ฟ๐บ๐๐น๐น๐ถ๐ฒ๐ ๐ฆ๐ผ๐น๐๐๐ถ๐ผ๐ป: ๐ผ ๐๐๐จ๐ โ๐ฝ๐๐จ๐๐, ๐๐ฃ๐ฉ๐๐๐ง๐๐ฉ๐๐ ๐ผ๐ฅ๐ฅ๐ง๐ค๐๐๐ ๐๐ฆ ๐ฆ๐ฎ๐ฃ๐ฆ๐ฅ ๐๐น๐ ๐ค๐ฐ๐ฎ๐ฑ๐ญ๐ช๐ข๐ฏ๐ค๐ฆ, ๐๐๐ ๐ฆ๐น๐ฆ๐ค๐ถ๐ต๐ช๐ฐ๐ฏ, ๐ข๐ฏ๐ฅ ๐ท๐ข๐ญ๐ช๐ฅ๐ข๐ต๐ช๐ฐ๐ฏ ๐ด๐ต๐ณ๐ข๐ต๐ฆ๐จ๐ช๐ฆ๐ด ๐ข๐ต ๐ฆ๐ท๐ฆ๐ณ๐บ ๐ฑ๐ฉ๐ข๐ด๐ฆโ๐ง๐ณ๐ฐ๐ฎ ๐ง๐ข๐ค๐ช๐ญ๐ช๐ต๐บ ๐ฅ๐ฆ๐ด๐ช๐จ๐ฏ ๐ต๐ฉ๐ณ๐ฐ๐ถ๐จ๐ฉ ๐ง๐ถ๐ญ๐ญโ๐ด๐ค๐ข๐ญ๐ฆ ๐ฐ๐ฑ๐ฆ๐ณ๐ข๐ต๐ช๐ฐ๐ฏโ๐ฆ๐ญ๐ช๐ฎ๐ช๐ฏ๐ข๐ต๐ช๐ฏ๐จ ๐ด๐ช๐ญ๐ฐ๐ด ๐ข๐ฏ๐ฅ ๐ฆ๐ฏ๐ด๐ถ๐ณ๐ช๐ฏ๐จ ๐ณ๐ฆ๐จ๐ถ๐ญ๐ข๐ต๐ฐ๐ณ๐บ ๐ด๐ถ๐ค๐ค๐ฆ๐ด๐ด ๐ง๐ณ๐ฐ๐ฎ DAY ONE! โ ๐๐ผ๐บ๐บ๐ถ๐๐๐ถ๐ผ๐ป๐ถ๐ป๐ด, ๐ค๐๐ฎ๐น๐ถ๐ณ๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป & ๐ฉ๐ฎ๐น๐ถ๐ฑ๐ฎ๐๐ถ๐ผ๐ป (๐๐ค๐ฉ) โ ๐ค๐๐ฎ๐น๐ถ๐๐ ๐ฅ๐ถ๐๐ธ ๐ ๐ฎ๐ป๐ฎ๐ด๐ฒ๐บ๐ฒ๐ป๐ (๐ค๐ฅ๐ ) โ ๐๐ผ๐บ๐ฝ๐๐๐ฒ๐ฟ ๐ฆ๐๐๐๐ฒ๐บ ๐ฉ๐ฎ๐น๐ถ๐ฑ๐ฎ๐๐ถ๐ผ๐ป (๐๐ฆ๐ฉ) & ๐๐ฎ๐๐ฎ ๐๐ป๐๐ฒ๐ด๐ฟ๐ถ๐๐ โ ๐ข๐ฝ๐ฒ๐ฟ๐ฎ๐๐ถ๐ผ๐ป๐ฎ๐น ๐๐ ๐ฐ๐ฒ๐น๐น๐ฒ๐ป๐ฐ๐ฒ & ๐๐ฒ๐ฎ๐ป ๐ฆ๐ถ๐ ๐ฆ๐ถ๐ด๐บ๐ฎ โ ๐ฃ๐ฟ๐ผ๐ท๐ฒ๐ฐ๐ ๐ ๐ฎ๐ป๐ฎ๐ด๐ฒ๐บ๐ฒ๐ป๐ & ๐๐ ๐ฒ๐ฐ๐๐๐ถ๐ผ๐ป โ ๐ฃ๐ฎ๐ฐ๐ธ๐ฎ๐ด๐ถ๐ป๐ด ๐๐๐๐ผ๐บ๐ฎ๐๐ถ๐ผ๐ป & ๐ฆ๐ฒ๐ฟ๐ถ๐ฎ๐น๐ถ๐๐ฎ๐๐ถ๐ผ๐ป ๐๐ผ๐บ๐ฝ๐น๐ถ๐ฎ๐ป๐ฐ๐ฒ ๐ช๐ต๐ ๐๐ฒ๐ฎ๐ฑ๐ฒ๐ฟ๐ ๐ง๐ฟ๐๐๐ ๐๐๐๐ง๐ข๐ผ๐ก๐ก๐๐๐จ ๐น ๐ช๐ฒ ๐๐๐ถ๐น๐ฑ ๐๐ผ๐บ๐ฝ๐น๐ถ๐ฎ๐ป๐ฐ๐ฒ ๐ณ๐ฟ๐ผ๐บ ๐๐ฎ๐ ๐ข๐ป๐ฒ ๐น ๐ฆ๐ฒ๐ฎ๐บ๐น๐ฒ๐๐ ๐๐ค๐ฉ & ๐๐ ๐ฃ ๐๐ ๐ฒ๐ฐ๐๐๐ถ๐ผ๐ป ๐น ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ ๐ฝ๐ฒ๐ฟ๐๐ถ๐๐ฒ, ๐ฅ๐ฒ๐ฎ๐น-๐ช๐ผ๐ฟ๐น๐ฑ ๐๐ ๐ฒ๐ฐ๐๐๐ถ๐ผ๐ป ๐น ๐๐ผ๐๐ & ๐ฅ๐ถ๐๐ธ ๐ ๐ถ๐๐ถ๐ด๐ฎ๐๐ถ๐ผ๐ป ๐ฏ ๐๐๐๐ ๐๐ญ๐-๐๐๐๐๐ฎ ๐๐ค๐ก๐ช๐ฉ๐๐ค๐ฃ๐จ ๐๐ค๐ง ๐๐ค๐ช๐ง ๐๐๐๐๐ก๐๐ฉ๐ฎ?
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Latest activity from PharmAllies
7 signals
Research & Knowledge
PharmAllies conducted a CSA risk assessment that found fifty-four out of sixty-one functions came back high risk after the site had transitioned.
Research & Knowledge
PharmAllies completed a line balancing project that worked after six weeks, bringing in Peniel Ortega after the second investigation.
Operations & Supply
PharmAllies delivered a project four months late.
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