Documentation
INVpack has an area responsible for generating and ensuring that equipment includes the next technical documentation:
- Machine drawings: Coil plan, Layout, Electrical & Pneumatic drawings, P&ID
- Electrical & Pneumatical components list
- Bill of material (Spare parts, Replacements and Recommended lubricant)
- Technical data and required supplies
- Installation manual
- Operation & user manual
- Maintenance & cleaning manual
- Programme security copy (Backup/Restore)
- European Conformity Certificate
And assure that machine is in concordance with safety regulations (2006/42/CE, Electromagnetic Compatibility Guideline 2004/108/CE, and Low-Tension Regulations Guideline 2008/95/CE).
In addition to the documentation required for use, operation, and maintenance, also the customer can request the following services:
Oriented to Pharma sector, according to GMP annex 11 & 15, US 21 CFR Part 11 and GAMP 5, INVpack offers Machine Qualification Package which integrates:
- Validation Master Plan (VMP)
- Risk Analysis in line with ICH Q9 (RA)
- Functional Specifications (FS)
- Design Specifications & Qualification (DS/DQ)
- Hardware & Software Specifications (HSS)
- Hardware & Software Qualification (HSQ)
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
Focus on Food sector and agreeing with ISO 22.000, presents Risk Analysis & Control Critical Points (HACCP) focus on equipment and Certificates of materials in contact with the product (in agreement with CE 1935/2004 & CE 10/2011).
Regarding User Safety Terms, Machine Failure Mode and Effects Analysis (FMEA) and in Explosion Safety Terms, Equipment Explosion Risk Evaluation Study (ATEX) are also provided.
