The right team for your team.

WE ARE A STRATEGIC PARTNER to biopharmaceutical manufacturing organizations for validation and quality consulting. At SpecLine, we provide customized support to our clients by bringing in carefully selected expertise to ensure consistent, efficient, and quality solution delivery. Our close attention to the specific goals of our clients make us the foremost experts and partners in regulatory work. We follow a set of defined processes within a quality system.

WE ARE HERE FOR YOU. Outsourcing validation project management brings supplemental attention and experience to a project when support is needed. With a constantly changing regulatory environment, our top priority is to ensure our clients maintain compliance in their operation.

We work to continuously identify new regulatory policies and requirements, so we can target the most cost effective approach to market from discovery to commercialization.

FLEXIBLE.  TIMELY.  DEVOTED.  We are available for projects lasting a week or a year, with flexible scheduling to meet your needs.

IQ/OQ/PQ Services & Documentation

Validating your processes and equipment is an essential activity, particularly in the current regulatory climate. We bring the validation experience you need. Our team members pride themselves on seamlessly integrating with your company in order to get the job done quickly and within budget. Always striving to meet our clients’ expectations, and working within a set of clearly defined processes, we guarantee you high-quality solutions.

Equipment Validation

From bioreactors, to chromatography columns, to tablet presses, to packaging robotics, to labeling vision systems: We have the experience and skill you need to bring your equipment online to support your production goals. We use a risk-based approach to ensure that all of your equipment meets current compliance standards, and we also work to increase overall efficiency and reliability of the equipment and instruments upon which you so heavily rely.

IT Management and Computer Systems Validation

The SpecLine team has experience navigating scientific and regulatory policies and requirements. Our computer systems validation (CSV) experts provide total project management, from concept and prototyping, through the system’s operational life, and on through maintenance, change control, and retirement. Our risk-based approach to validation saves time and money, provides assurance of correct and compliant functions, and creates real value for the patient, the system end users, and you. Ask us today how we can help you with your computerized systems and validation needs.

Quality Management

Your goal is to produce high quality products efficiently, affordably, and in full FDA compliance. Our goal is to work hand-in-hand with you in order to ensure quality management. This includes ISO-9000 activity, process definition, record keeping, and control of products and services provided. These facets overlap with the regulatory interest, particularly in the expectations of regulators regarding quality constructs (records, evidence, and signatures).

Project Management

Our team is incredible when it comes to working with you in order to oversee a complete project. We aren’t afraid to wear multiple hats and do whatever it takes to see that the job is done. From budget and cost controls to resource allocation and executive oversight, we are an effective partner with efficiency and productivity in mind.

Technical Writing & Custom Templates

SpecLine is skilled in handling a variety of technical writing needs. We can effectively convey and communicate understanding of complex scientific processes and procedures in writing and via developed training modules. Working extensively with Validation Protocols, Validation Master Plans, Risk Assessments, and Standard Operating Procedures, we can help you better define and bring value to your company’s quality, validation and training programs.