GxP Audits
Clintask Solutions provides GxP compliance services, including GCP, GLP/GCLP, CSV/CSA, cGMP, and PV.
We regulate audits to assess ensuring full regulatory compliance.
Our team identifies any potential gaps or risks that could compromise quality, safety, or regulatory compliance, providing you with actionable recommendations that align with industry best practices.
Our GxP Standards : Ensuring Quality, Safety, and Compliance
GCP
- Investigator site (CROs/FSP)
- GxP gap assessments & Mock inspections
- CDM/PK and Biostatistics
- Systems & Internal processes(QMS)
- Pre-inspection readiness and Risk based assessments
GLP
- CRO/Vendor
- Study audits,Study Plans and Amendments
- Study report & Raw data
- Bio-analytical laboratory.
GCLP
- Vendor qualifications
- Gap assessments
- SOP development
GMP
- Qualification/Re-Qualification auidts
- QMS complaince and Gap analysis
- For cause auidts
- Vendor audits
GVP
- PV system
- PSMF
- SLA sase processing compliance oversight
- RCA & CAPA
CSV
- GxP computerized system validations
- GxP IT consulting
- 21 CFR PART 11 complaince and Annex 11 complaince
- SDLC process
GCP |
GPV |
GCLP |
GMP |
GVP |
CSV |
| Investigator site (CROs/FSP) | CRO/Vendor | Vendor qualifications | Qualification/Re-Qualification auidts | PV system | GxP computerized system validations |
| GxP gap assessments & Mock inspections | Study audits,Study Plans and Amendments . | Gap assessments | QMS complaince and Gap analysis | PSMF | GxP IT consulting |
| CDM/PK and Biostatistics | Study report & Raw data | SOP development | For cause auidts | SLA sase processing compliance oversight | 21 CFR PART 11 complaince and Annex 11 complaince |
| Systems & Internal processes(QMS) | Bio-analytical laboratory. | Vendor audits | RCA & CAPA | SDLC process | |
| Pre-inspection readiness and Risk based assessments |