Regulatory Compliance Associates Inc. has a comprehensive knowledge base of process validation. Our staff has decades of combined experience in assessing compliance strategy, authoring, executing, and summarizing process validations utilizing prospective or concurrent approach strategies for the Pharmaceutical, Biotechnology, and Medical Device Industries. We work with client provided existing formats, utilize Regulatory Compliance Associates Inc. extensive library, or create custom formats as required meeting our client’s specific qualification requirements. The result provides a high degree of assurance that all applicable regulatory requirements are satisfied, utilizing an “owner’s perspective” to cost containment from planning and team building, through turnover. Typical documentation may include:
- Validation Master Plans
- User Requirement Specifications
- Functional Design Specifications
- DQ’s, IQ’s, OQ’s, and PQ’s
- Summary Reports and Documentation
- Deviation Documentation and Justification
Cleaning Validation
Regulatory Compliance Associates Inc. provides comprehensive services for cleaning validation programs. Our services include Cleaning Program Strategy, Cleaning Validation Master Planning, Creation of Cleaning Protocols, Summary Documentation, SOPs, staff training, and implementation support