Equipment Qualification & Validation


Are your validations overdue? Are you running short on time and resources?
If you have equipment that needs qualification or requalification, but lack the time or the expertise, we can help.
We can performpart of the qualification, e.g. Installation Qualification (IQ) and/or Operational Qualification (OQ), or we can performthevalidation from start to finish, including assisting with Validation Master Plan (VMP), User Requirement Specification (URS) etc.
We have a pragmatic approach to qualification and validation: Focus on compliance and keep it simple!

Requirement Specifications

Long experience with preparation of equipment requirement specifications.

Validation Plans

Preparation of both Validation Master Plans and individual Validation Plans.

Risk Assessment

Performance and facilitation of FMEA/FMECA risk analysis in accordance with ISO 14971:2019.

Validation Protocols

Extensiveexperience in preparation of IQ, OQ & PQ protocols.

Validation Performance & Reporting

A solid hands-on experience in performing validation activities and reporting according to the authorities’ expectations.

Statistical Methods

Calculation of statistically based sample sizes and acceptance criteria for attributive and variables validation data.
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Pharma4ever A/S

Agervej 4, 4340 Tølløse

+45 42 70 20 90
CVR: 36436573