Compliance & Validation for Lab Systems
At Avacone India, we offer specialized compliance and validation services tailored to meet the regulatory demands of pharmaceutical, biotech, healthcare, and food testing laboratories. Our approach is aligned with international standards like GAMP 5, 21 CFR Part 11, and EU Annex 11, ensuring your lab systems operate with integrity, security, and full audit traceability.
Validation of Lab Software (as per GAMP 5, 21 CFR Part 11, EU Annex 11
Key Offerings:
Validation planning and execution per GAMP 5 V-model
Compliance mapping to 21 CFR Part 11 and Annex 11
Validation of cloud-based, hybrid, and on-premise systems
Testing for data integrity, electronic signatures, audit trails
Revalidation after patches, upgrades, or change control
Whether you’re implementing a new lab application or upgrading an existing one, software validation is a regulatory requirement for ensuring systems are fit for their intended use. We perform full-lifecycle validation for systems like LIMS, ELN, CDS, and instrument software, aligning our work with GAMP 5 and other global regulatory frameworks.
Our validation ensures your software systems are compliant, reliable, and fully traceable—reducing the risk of data breaches, non-conformities, and audit findings.
Regulatory bodies place strong emphasis on traceable, controlled documentation during software qualification and validation. We support you with comprehensive, audit-ready documents covering the full validation lifecycle—from User Requirement Specification (URS) to Performance Qualification (PQ).
Our expert teams create documentation in alignment with your QMS and IT policies, ensuring completeness, clarity, and consistency across validation projects.
Documentation: URS, RA, FS, DS, IQ, OQ, PQ, TM, VP
Key Offerings:
Creation of URS, FS, DS, RA, TM, and VP
Qualification documents: IQ, OQ, PQ with traceability matrix
Support for GxP-aligned documentation templates
Customizable formats as per client SOPs
Document reviews, approvals, and archival in DMS
Audit & Inspection Readiness
Key Offerings:
GxP system audit readiness assessments
Gap analysis & remediation planning
Mock audits for FDA, MHRA, WHO, and client inspections
Data integrity compliance checks
CAPA management and SOP alignment
Being audit-ready at all times is crucial for regulated labs. Our validation experts prepare your lab systems for internal audits, external regulatory inspections (FDA, EMA, WHO), and customer audits by identifying gaps and remediating them proactively.
We conduct mock audits, gap assessments, and readiness workshops to ensure your lab systems, documentation, and SOPs meet the strictest regulatory standards.
SOP Creation & Controlled Document Support
Standard Operating Procedures (SOPs) form the foundation of a compliant laboratory operation. We assist in drafting, reviewing, updating, and maintaining SOPs that align with regulatory frameworks and your organizational policies.
Our SOPs are clear, actionable, and designed to reduce operational variability while supporting training, audit preparedness, and system governance.
Key Offerings
- SOP development for lab systems, validations & IT processes
- Template creation for controlled documentss
- Version control and document lifecycle management
- Alignment with regulatory & internal compliance standards
- Training guides and procedural documents
