Data Integrity and
Software Implementation
Achieve compliance and operational efficiency
Today’s data-driven life sciences industry, data integrity is necessary for both regulatory compliance and operational success. At BioBoston Consulting, we offer comprehensive data integrity and software implementation solutions that ensure your data remains accurate throughout its entire lifecycle while ensuring that it is consistent with international standards.
Why Choose Data Integrity and Software Implementation by BioBoston Consulting?
A Complete Expert on Data Integrity
Our team is highly experienced in ensuring data integrity throughout all stages of product development and production. We are able to assist you in adopting business activities which comply with standards such as 21 CFR Part 11, ALCOA+ principles and other necessary regulatory requirements.
Custom Software Solutions
We understand that different companies are in different situations. Our professionals are here to work with you to find the most suitable software solution for managing, tracking and reporting your data. We are by your side when it comes to choosing, validating and implementing software in ways that streamline operations while remaining compliant with all relevant rules.
Risk management and Compliance
In the world of data integrity, compliance with regulatory authorities is paramount. We are here to help you identify any potential risks and take action in time so that your data management systems are secure, traceable and compliant with the latest rules.
Seamless Integration
Our talented team is involved in liaising data integrity practices with your existing processes and systems. If you are carrying out a software upgrade or seeking out a new system, we make transitions smooth by minimizing disruption.
Related Regulation Knowledge All Around the World
We are very familiar with the data integrity laws of all countries. Also, we make sure that you comply with local requirements for equipment and procedures while delivering superior software products. In fact, if your state has a requirement as strict as those stipulated by the authorities in Boston, EMA ‘s establishments in Europe or Asia’s authorities, we can adapt what is needed to be done in order to meet such high level standards.
Our Data Integration and Software Implementation Services:
Data Integrity Audits
In depth assessments your present data intelligence systems
Data Plan Creation and Implementation for Data Integrity
Action plans to address data integrity gaps and in accordance with ALCOA+ principles and regulatory requirements.
Selection Validation Implementation and Training of Software Systems
Assist with inspection, testing, acceptance procedures, and acceptance of software which make better data management possible while enabling audit compliance.
Software Implementation and Integration
Providing extensive support in bringing software programs automatically into full service and making them an organic part of the already existing process.
Extensive Training and Supporting
Providing training in all the most important data integrity principles as well as the use of new software systems to your organization until it becomes second nature. We offer the benefit of parallel translations for some languages.
Mid-term Control and Guidelines for your Ongoing Obligations
Support which goes beyond the point of usage: including regular inspections or comparative testing undertaken to guarantee retention of data validity while also meeting changing rules.
Be Your Premier Backstop In Data Integrity With BioBoston Consulting
Our Data Integrity plans and software systems ensure your life sciences company adheres to the highest standards of data integrity while realizing maximal operational efficiency. Let us help put secure, regulation-compliant software in place that actually works for your business.
Get In Touch Today
Make a meeting with staff at BioBoston Consulting for your data integrity and software implementation issues.
All Services
- Quality Assurance and Regulatory Compliance
- Investigational New Drug (IND) Application
- Regulatory Strategy & Submissions
- Investigational Device Exemption (IDE) Application
- Vendor Selection & Qualification
- Project & Risk Management
- Technology Transfer
- Quality Management Systems (QMS)
- Gap Assessment and Remediation
- Funding and Investment Strategies
- Research and Development (R&D)
- Biostatistics and Data Analysis
- Lab Operations and Efficiency
- Medical Writing
- CDMO Vendor Selection Qualification & Oversight
- CRO Selection & Qualification
- CTO Selection & Qualification
- Data Integrity and Software Implementation
- Clinical Operations
- Clinical Trial Monitoring
- FDA Inspection Readiness
- Internal and Supplier Audits
- Regulatory CMC Support
- Qualification and Validation
- GxP Training
- Computer System Validation (CSV)
- Strategic Advising
- Process Optimization
- Health Authority Meeting Support
- Recruitment