Validation Services

Pragmatic risk based approach that validates right fi rst time

SeerPharma has been successfully supporting Life Science businesses for over 20 years in this complex compliance environment.

At SeerPharma, our experienced validation consulting team fully understands all international compliance standards, the benefi ts of leveraging risk analysis in validation and ensuring GxP critical systems are validated right first time. We have a proven track record of bringing client projects in on time and within budget.

We adopt a pragmatic approach to validation and project management using risk assessments and the ASTM E2500 framework. This minimizes documentation without compromising business control.

SeerPharma can project manage global, regional or local validation programs for clients and if required will supply implementation staff to execute the project under a single point of responsibility.

 Our industry experience reduces your cost

Through the understanding of best practices and the application of lessons learnt, SeerPharma can help reduce risk, reduce cost of validation and improve system quality by:

• Developing Validation Master Plans
• Writing validation documentation (plans, protocols, reports)
• Performing validation oversight and quality assurance services
• Conducting computer system GAMP compliance gap analysis
• Providing 21 CFR Part 11 assessments and remediation
• Implementing effective validation training programs
• Developing IT governance procedures
• Conducting validation according to intended use
• Recommending risk based validation strategies

SeerPharma has experience in validation across multiple life science product areas including sterile, biological, solid dose, liquid and medical devices.

We deliver Confidence in Compliance

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