Regulatory Compliance Associates Inc. has a comprehensive knowledge base of facility, utility, and equipment validation. Our staff has decades of combined experience in assessing compliance strategy, authoring, executing, and summarizing infrastructure qualifications 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
- White Papers