AdaptQMS helps organisations ensure computerised systems and data are reliable, compliant, and inspection ready. 

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We support compliance with:​

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• 21 CFR Part 11, PIC/S, and EU Annex 11

• GAMP 5 and Computer Software Assurance (CSA)

• ICH E6(R3) (Good Clinical Practice)

• IEC 62304 (Medical Device Software lifecycle)

• ISO 90003 and Data Integrity guidelines

 

Our services include:

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• CSV master plans and validation plans tailored to system
  criticality

• Electronic Records & Electronic Signatures (ERES) assessments

• Implementation and validation of eQMS and LIMS solutions

• Framework reviews and documentation remediation

• Risk-based assessments and compliance remediation

• Training and mentoring to enable sustainable compliance

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