YAVEON Compliance Kit

The YAVEON Compliance Kit is a documentation package specifically developed for the life sciences industry. It includes standardized, GAMP 5-compliant validation templates that meet regulatory requirements according to the EU-GMP guidelines (including Annex 11) and 21 CFR Part 11.

• The Compliance Kit covers all phases of the validation process for the Microsoft Dynamics 365 Business Central and YAVEON ProBatch ERP system: – Supplier Qualification of YAVEON and Microsoft
• Standard user requirements and traceable functional specifications including risk assessments in accordance with GAMP5
• FMEA Risk assessment for Cloud environments
• Standard SOPs for Update Management and System Operation
• Validation Plan and Report.

Once delivered, the documents become the responsibility of the customer. Thanks to their modular structure and high level of standardization, they can be efficiently tailored to specific project needs with minimal effort. The result: significantly reduced project durations and validation costs – with full regulatory security and audit readiness.

Supported Countries:

DE, US, CA, FR, BE, NL, GB, AU, SE, AT,CH, NO, IT, ES, TR, PA, AR, MX, PT, PE, CO, DK, FI, BR, IS, PL, HK, IN, NZ, AO, AD, BS, BH, BM, VG, CM, KY, CL, CR, HR, CY, CZ, DO, EC, EG, SV, EE, ET, FO, FJ, GE, GH, GR, GT, HN, ID, IE, IM, IL, JP, KE, KR, LV, LT, LU, MG, MT, NA, NG, MK, PR, RO, SN, RS, SG, SK, SI, ZA, TN, UG, AE, MY, PH, KH, TW, TH, VN, KR

Supported Languages:

EN, DE