Services

Make the most of your investment in BIOVIA solutions with lab-to-plant process consulting, onsite implementation, expert training and superior support

Regulatory Support

System Validation

BIOVIA Management Consulting supports customers in the preparation of the validation plan, user requirements and functional design specifications, and in writing Installation Qualification, Operational Qualification and Performance Qualification plans. We also provide support in carrying out the corresponding tests and their documentation all in line with the current rules and regulations (e.g., GAMP5 and 21 CFR Part 11).

Life-cycle Management

Once a system is up and running, procedures must be put in place to keep it qualified for its use. Maintenance, upgrades, improvements and adoptions to any changes need to be carried out according to strict change management procedures. BIOVIA Management Consulting will help establish these procedures, carrying out testing and qualification of changes to keep the system compliant with qualification requirements.

e-Records

Not all electronic records are generated with Part 11 compliant systems. BIOVIA Management Consulting will support its customers in developing strategies to manage all electronic records in a Part 11 compliant manner, maintaining version control, audit trails and record protection according to ยง11.10 of 21 CFR Part 11.

e-Signatures

BIOVIA Management Consulting identifies when and where to execute electronic signatures in a system, setting up controls and policies for identification codes and passwords, from simple electronic signatures with username and password up to biometric devices that fit specific customer needs.

Interfacing solutions, Part 11 compliant and validated

BIOVIA Management Consulting implements and validates interfaces using well established and proven methods, resulting in a 21 CFR Part 11 compliant and validated implementation.

Industry Guidelines and Specifications

21 CRF PART 11
(U.S. Department of Health and Human Services, Electronic Records; Electronic Signatures; Final Rule & Electronic Submissions; Establishment of Public Docket; Notice)

GUIDANCE FOR INDUSTRIES
(U.S. Department of Health and Human Services, Guidance for Industry Part 11, Electronic Record; Electronic Signatures — Scope and Application)

EU-GMP-ANNEX 11
(European Commission Health and Consumers Directorate - General, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 11: Computerized Systems)

40 CFR PARTS 3, 9, 51 ET AL.
(Environmental Protection Agency. Cross-Media Electronic Reporting; Final Rule)

OECD GLP CONSENSUS
(OECD Series On Principles of Good Laboratory Practice and Compliance Monitoring)

PIC/S GUIDANCE PI 011-2
(Pharmaceutical Inspection Convention, Good Practices for Computerised Systems in Regulated "GXP" Environments)

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