Strict Adherence to Regulatory and Safety Compliance Guidelines
From Class 1 Lasers to following Current Good Manufacturing Practice (CGMP) regulations, Ackley strictly adheres to all FDA and CE compliance guidelines which are essential to the health and safety of workers and consumers.
Below is a general list of our FDA & CE machine compliance information. For complete and specific compliance information regarding a machine – please contact us for details.
Safety and Regulatory Compliance:
- Designed in accordance with cGMP regulations:
- FDA 21 CFR Parts 210-211: Current Good Manufacturing Practice for Pharmaceuticals.
- Computerized system is compliant with:
- FDA 21 CFR Part 11: Electronic Records; Electronic Signatures.
- Compliant with European CE Directives:
- Machinery Directive 2006/42/EC
- Low Voltage Directive 2014/35/EU
- Electromagnetic Compatibility Directive 2014/30/EU
- Laser systems are compliant with:
- 21 CFR Part 1040.10: Performance Standards for Laser Products. (Laser Product Classification – Class I)
- International Laser Safety Standard:
- IEC 60825-1: Safety of laser products.
- International Safety Standards:
- ISO 13849-1: Safety of machinery. Safety-related parts of control systems. (SRP/CS Performance Level: Category 3, PL d)
- IEC / EN 60204-1: Safety of machinery. Electrical equipment of machines.
- National Fire Protection Association:
- NFPA 79: Electrical standard for industrial machinery.
- Canadian Food and Drug Regulations:
- C.R.C., c. 870: Food and Drugs Act; C.02.005 (GMP – Equipment)